Public safety
Current recall notices for food, drugs, and meat and poultry products in the United States, drawn from Food and Drug Administration enforcement reports and U.S. Department of Agriculture recall notices. Each entry lists what was recalled, why, the risk level, and where the product was sold.
Last checked: (3 hrs ago)· Refreshes automatically every 3 hours from FDA and USDA
Showing 775 of 775 active recalls
Reason: Revival Animal Health of Orange City, IA is recalling Breeder’s Edge® and Shelter’s Choice® Feline Milk Replacers due to low, levels of potassium, copper, folic acid, choline and/or pyridoxine (vitamin B6).
Reason: Jaime’s Foods ATX of Austin, TEXAS is recalling Jaime’s Spanish Village Jalapeno Ranch because it contains undeclared eggs. People who have an allergy or severe sensitivity to eggs run the risk of serious or life-threatening allergic reaction if they consume this product.
Reason: Las Vegas, NV – August 24, 2026 – The Better Bakehouse Snack Company is recalling certain lots of Donutful Chocolate Dipped Vanilla Cake Donuts because the product may contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening aller
Reason: Everything Sprouts, LLC, based in Minneapolis, MN is recalling certain lots of Alfalfa Sprouts because it has the potential to be contaminated with Shiga toxin producing Escherichia coli (STEC) or Salmonella bacteria.Shiga toxin-producing Escherichia coli (STEC) are organisms that can cause serious
Reason: Prince Bakery of Bronx, New York is recalling Prince brand Sesame Italian Bread, Large Italian Bread, Large Sesame French Bread, Long Sesame French Bread and Pan de Manteca Spanish Style Bread because they may contain undeclared sesame or milk. People who have an allergy or severe sensitivity to s
Reason: August 18, 2026 - Dreyer’s Grand Ice Cream, Inc. is voluntarily recalling a limited number of select flavors of Outshine Fruit Bars due to possible foreign material contamination with glass. Products affected include Outshine Strawberry, Watermelon, Grape, Tangerine and Black Cherry 6-Count 2.5 ounc
Reason: L-Nutra of Culver City, California is recalling Prolon brand Apulian Almond & Cocoa Spread because it contains undeclared cashew, pistachio, and hazelnut. People who have an allergy or severe sensitivity to cashew, pistachio, and/or hazelnut run the risk of serious or life-threatening allergic react
Reason: Oma's Pride of Avon, Connecticut, is voluntarily recalling one lot of Woof Complete Canine Chicken Recipe, 6 lb bag (Lot BB012729) because it is contaminated with Salmonella.
Reason: Produced without federal inspection
Reason: Import violation
Reason: The Hampton Grocers, Inc. of Montauk, NY is recalling Lacnola Lactation Granola, 8oz, because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune system
Reason: August 14, 2026, Exotique Foods Inc in Ontario, Canada is recalling Momchipz Veggie Chips Broccoli Florets & Cauliflower because it may contain undeclared wheat. People who have an allergy or severe sensitivity to wheat run the risk of serious or life-threatening allergic reaction if they consume
Reason: August 19, 2026, Grand Central Bakery of Seattle, WA is recalling loaves of Potato Sourdough bread due to the potential presence of pieces of metal.
Reason: Kettle Cuisine LLC of Savage, MD is recalling Marketside Tomato Bisque Soup Kit – 14oz (397g) because the product has the potential to be contaminated with Listeria monocytogenes, an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others
Reason: Dairyland Produce, LLC, dba Hardie’s Fresh Foods of Houston, TX and Dallas, TX are recalling PEPPER JALAPENO 5#, because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others
Reason: AUSTIN, Texas — Whole Foods Market is recalling select products from its Produce and Prepared Foods departments that contain jalapeños sourced from Coast Citrus Distributors due to potential Salmonella contamination. Salmonella is an organism which can cause serious and sometimes fatal infections in
Reason: HOUSTON, TX (August 11, 2026) – Salata Dressings of Houston, TX, is recalling its Jalapeno Avocado Dressing because it had the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with
Reason: ARLINGTON, VA – AUGUST 11, 2026 – Lidl US is recalling one lot of Vitasia Asian Style Wok Spice Mix 1.58 oz (45g) (UPC 4335619355491) with Lot # 155846 and BBD JUN 2028 because it has the potential to be contaminated with Salmonella.
Reason: Laval, Quebec Frankie's Organic is recalling 94 cases of Frankie’s Organic Plant-Based Vegan Cheddar Puffs because it may contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.
Reason: Salinas, Calif., August 9, 2026 – Upon notification that Coast Citrus Distributors is voluntarily recalling fresh jalapeños due to potential Salmonella contamination, Taylor Fresh Foods is recalling finished products containing jalapeños subject to this recall.Salmonella, an organism which can cause
Reason: NatureBest Precut & Produce LLC, with facilities located in Missouri City, TX and Houston, TX is voluntarily recalling products containing jalapeño peppers supplied by Coast Citrus Distributors due to the potential for contamination with Salmonella. Salmonella is an organism which can cause serious
Reason: Possible Salmonella Contamination
Reason: Possible Listeria Contamination
Reason: Lexunder Inc., doing business as Food To Live of Brooklyn, NY, is recalling Food to Live brand green powder products because they have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and
Reason: Import violation
Reason: Import violation
Reason: CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
Reason: August 5, 2026 — Sun Noodle of Honolulu, Hawaii is voluntarily recalling 134 packages (15.4oz) of Sura Tanmen Hot and Sour Flavor Premium Japanese Noodles & Soup Base, because the product may contain undeclared fish allergen. People who have an allergy or severe sensitivity to fish run the risk of a
Reason: Failed Dissolution Specifications
Reason: Blank Slate Creamery of Ann Arbor, MI is recalling its 4.5 oz. packaged VEGAN NON-DAIRY FROZEN DESSERT COCONUT FUDGE SANDWICHES, because it may contain undeclared egg. People who have an allergy or severe sensitivity to eggs run the risk of serious or life-threatening allergic reaction if they consu
Reason: CGMP Deviations:Noted during FDA inspection
Reason: CGMP Deviations:Noted during FDA inspection
Reason: CGMP Deviations:Noted during FDA inspection
Reason: CGMP Deviations:Noted during FDA inspection
Reason: CGMP Deviations:Noted during FDA inspection
Reason: Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.
Reason: Possible Foreign Matter Contamination
Reason: Possible Listeria monocytogenes contamination
Reason: Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles.
Reason: Undeclared allergen (egg)
Reason: Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Reason: Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Reason: Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Reason: Lack of assurance of sterility. The recall is due to potential contamination
Reason: Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Reason: Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Reason: Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Reason: Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Reason: Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Reason: Misbranding and Undeclared Allergen
Reason: Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Reason: Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Reason: Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Reason: Undeclared Red #40.
Reason: Undeclared milk from lactose.
Reason: Import violation
Reason: Label declares cream and cheese, but Milk is not declared
Reason: shortfill; reports of empty capsules.
Reason: CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received.
Reason: Import violation
Reason: Possible Salmonella Enteritidis
Reason: Possible Salmonella Enteritidis
Reason: Defective Container: Firm received multiple complaints of broken cap spikes and undeliverable drops.
Reason: Possible Salmonella in Moringa Leaf Powder product.
Reason: Undeclared Soy. The firm received complaints of sausage in the burritos. Upon review the firm discovered the sausage contains soy which is not listed on the label.
Reason: Presence of Particulate Matter; identified as stainless steel
Reason: Presence of Particulate Matter; identified as stainless steel
Reason: Flexible food pouch may release thin plastic strips into food.
Reason: Incorrect Product Formulation
Reason: Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability
Reason: Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability
Reason: Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability
Reason: Presence of Particulate Matter: Hair was found in products
Reason: Presence of Particulate Matter: Hair was found in products
Reason: Presence of Particulate Matter: Hair was found in products
Reason: Presence of Particulate Matter: Hair was found in products
Reason: Presence of Particulate Matter: Hair was found in product
Reason: Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan
Reason: Lack of Assurance of Sterility
Reason: Lack of Assurance of Sterility
Reason: Lack of Assurance of Sterility
Reason: Lack of Assurance of Sterility
Reason: Lack of Assurance of Sterility
Reason: Lack of Assurance of Sterility
Reason: Failed Impurities/Degradation Specifications
Reason: Lack of Assurance of Sterility
Reason: Lack of Assurance of Sterility
Reason: Possible foreign object (thin, soft plastic strands).
Reason: Subpotent Drug
Reason: Subpotent Drug
Reason: Subpotent Drug
Reason: Subpotent Drug
Reason: Subpotent Drug
Reason: Subpotent Drug
Reason: Subpotent Drug
Reason: Subpotent Drug
Reason: Subpotent Drug
Reason: Subpotent Drug
Reason: Subpotent Drug
Reason: Presence of Precipitate: medication was crystallizing and particles floating in the bottle
Reason: Subpotent Drug
Reason: Allergen missing from contains statement: fish
Reason: Lack of Assurance of Sterility: Affected product may exhibit an open or incomplete seal on the packaging of the applicator
Reason: Moringa Powder ingredient positive for salmonella
Reason: Undeclared colors: Yellow#5, and Yellow#6.
Reason: No labeling. Undeclared wheat and colors: Yellow#5, Yellow#6.
Reason: Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications
Reason: Failed Dissolution Specifications
Reason: Lack of Assurance of Sterility
Reason: Potential E. coli O145:H28 Contamination
Reason: Misbranding and Undeclared Allergen
Reason: Presence of precipitate
Reason: Foreign Manufacturer label contains Undeclared allergen ingredients Wheat, Soy, Sesame, Yellow #5 and Blue #1 in Frozen Flounder Products.
Reason: Foreign Manufacturer label contains Undeclared allergen ingredients Wheat, Soy, Sesame, Yellow #5 and Blue #1 in Frozen Flounder Products.
Reason: Product label allergen "contains" statement does not include anchovy(fish)
Reason: Firm's finished product label does not declare the source of marine collagen which was determined to be fish.
Reason: Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
Reason: Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12 Month Long-Term Stability.
Reason: Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12 Month Long-Term Stability.
Reason: cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
Reason: cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
Reason: cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
Reason: Contaminated with Salmonella
Reason: Presence of Foreign Tablets/Capsules
Reason: Labeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER capsules.
Reason: Undeclared Allergen (Fish)
Reason: SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Reason: SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Reason: SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Reason: SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Reason: SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Reason: SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Reason: SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Reason: SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Reason: SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Reason: SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Reason: SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Reason: Misbranding and Undeclared Allergens
Reason: Misbranding and Undeclared Allergens
Reason: Possible Listeria monocytogenes contamination
Reason: Cross Contamination with Other Products: Customer complaints for appearance of discolored tablets and red dots observed on Cetirizine Hydrochloride Tablets USP 5 mg. Determined to be Ranitidine.
Reason: Lack of Sterility Assurance
Reason: Lack of Sterility Assurance
Reason: Lack of Sterility Assurance
Reason: Lack of Sterility Assurance
Reason: Failed Impurities/Degradation Specifications
Reason: Potential contamination with Salmonella
Reason: Undeclared Peanut. High Valley Orchard Chocolate Covered Raisins contains unintended undeclared peanut due to mis-packaging.
Reason: Subpotent Drug: Low out of specification assay results performed during long-term stability testing.
Reason: CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing.
Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Reason: Potential for spoilage.
Reason: Undeclared peanuts
Reason: Potential foreign material (glass)
Reason: Potential foreign material (glass)
Reason: Potential contamination with plastic material
Reason: Misbranding and Undeclared Allergens
Reason: Dietary supplement product Vista MAX contains undeclared Yellow#5.
Reason: Dietary supplement product Ocular Plus contains undeclared Yellow#5.
Reason: Potential contamination with plastic material
Reason: Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets.
Reason: Subpotent Drug
Reason: Undeclared peanuts.
Reason: Product may be contaminated with Clostridium botulinum.
Reason: CGMP Deviations: An incorrect detergent was used and the required swab sampling was not performed on a production hopper that had previously been used for a different product.
Reason: Crystallization; identified as Buprenorphine free base
Reason: Failed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification.
Reason: Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Reason: Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Reason: Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Reason: Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Reason: Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Reason: Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Reason: Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Reason: Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Reason: Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Reason: Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Reason: Foreign material: small metal pieces
Reason: Lack of assurance of Sterility:
Reason: Temperature Abuse: Product was stored incorrectly in a controlled room temperature environment instead of a refrigerated environment.
Reason: Lack of Assurance of Sterility
Reason: Subpotent Drug
Reason: Lack of Assurance of Sterility
Reason: Failed Impurities/Degradation Specifications
Reason: Products may be contaminated with Listeria monocytogenes.
Reason: Failed Dissolution Specifications
Reason: undeclared colors (yellow#5)
Reason: Products may be contaminated with Listeria monocytogenes.
Reason: Products may be contaminated with Listeria monocytogenes.
Reason: Products may be contaminated with Listeria monocytogenes.
Reason: Products may be contaminated with Listeria monocytogenes.
Reason: Presence of Foreign Substance
Reason: Presence of a Foreign Tablets: Complaint received, possible mix-up of Selexipag 1000 mcg tablet in a bottle of Lacosamide Tablets USP, 100mg.
Reason: Presence of Foreign Substance.
Reason: Presence of Foreign Substance.
Reason: CGMP Deviations
Reason: sub potency
Reason: CGMP Deviations
Reason: CGMP Deviations
Reason: Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process.
Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Reason: Product may contain metal fragments.
Reason: Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.
Reason: Undeclared sodium tripolyphosphate (STTP)
Reason: Undeclared sodium tripolyphosphate (STTP)
Reason: Undeclared sodium tripolyphosphate (STTP)
Reason: Incorrect product formulation: bag did not contain copper and famotidine per label.
Reason: Presence of foreign substance
Reason: CGMP Deviations; deficiencies observed during FDA inspection
Reason: CGMP Deviations; deficiencies observed during FDA inspection
Reason: CGMP Deviations; deficiencies observed during FDA inspection
Reason: CGMP Deviations; deficiencies observed during FDA inspection
Reason: CGMP Deviations; deficiencies observed during FDA inspection
Reason: CGMP Deviations; deficiencies observed during FDA inspection
Reason: CGMP Deviations; deficiencies observed during FDA inspection
Reason: CGMP Deviations; deficiencies observed during FDA inspection
Reason: CGMP Deviations; deficiencies observed during FDA inspection
Reason: CGMP Deviations; deficiencies observed during FDA inspection
Reason: CGMP Deviations; deficiencies observed during FDA inspection
Reason: CGMP Deviations; deficiencies observed during FDA inspection
Reason: CGMP Deviations; deficiencies observed during FDA inspection
Reason: Improperly eviscerated which may result in Clostridium botulinum contamination
Reason: CGMP Deviations; deficiencies observed during FDA inspection
Reason: Product contaminated with Listeria monocytogenes.
Reason: Product contaminated with Listeria monocytogenes.
Reason: Product contaminated with Listeria monocytogenes.
Reason: Product contaminated with Listeria monocytogenes.
Reason: Product contaminated with Listeria monocytogenes.
Reason: Product contaminated with Listeria monocytogenes.
Reason: Product contaminated with Listeria monocytogenes.
Reason: Product contaminated with Listeria monocytogenes.
Reason: Product contaminated with Listeria monocytogenes.
Reason: Product contaminated with Listeria monocytogenes.
Reason: Product contaminated with Listeria monocytogenes.
Reason: Product contaminated with Listeria monocytogenes.
Reason: Product contaminated with Listeria monocytogenes.
Reason: Product contaminated with Listeria monocytogenes.
Reason: Product contaminated with Listeria monocytogenes.
Reason: Product contaminated with Listeria monocytogenes.
Reason: Product contaminated with Listeria monocytogenes.
Reason: Product contaminated with Listeria monocytogenes.
Reason: Failed Impurities/Degradation Specifications
Reason: Labeling: Incorrect or Missing Lot and/or Exp Date
Reason: Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis
Reason: Microbial Contamination of Non-Sterile Products
Reason: Misbranding and Undeclared Allergens
Reason: Subpotent drug
Reason: Subpotent drug
Reason: Subpotent drug
Reason: Subpotent drug
Reason: Presence of Foreign Substance:This recall has been initiated in response to a product quality complaint reported for black/brown specs and particles within the ampoule solution
Reason: Failed Dissolution Specifications: During 12-month long-term stability testing, subject lot was out of specification (low) for stage 3 dissolution at the 24-hour timepoint.
Reason: Subpotent drug
Reason: Subpotent drug
Reason: Undeclared fish.
Reason: Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
Reason: CGMP Deviations
Reason: Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
Reason: Non-Sterility: Due to presence of Aspergillus penicillioides.
Reason: Non-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
Reason: Presence of foreign substance: small metallic particles in chewable tablets.
Reason: Presence of foreign substance: small metallic particles in chewable tablets.
Reason: Presence of foreign substance: small metallic particles in chewable tablets.
Reason: Presence of foreign substance: small metallic particles in chewable tablets.
Reason: Presence of foreign substance: small metallic particles in chewable tablets.
Reason: Presence of foreign substance: small metallic particles in chewable tablets.
Reason: Presence of foreign substance: small metallic particles in chewable tablets.
Reason: Presence of foreign substance: small metallic particles in chewable tablets.
Reason: The product contains undeclared Yellow 5 and 6, Blue 1, and unapproved Red 3.
Reason: Presence of foreign substance: small metallic particles in chewable tablets.
Reason: Presence of foreign substance: small metallic particles in chewable tablets.
Reason: Presence of foreign substance: small metallic particles in chewable tablets.
Reason: Presence of foreign substance: small metallic particles in chewable tablets.
Reason: Presence of foreign substance: small metallic particles in chewable tablets.
Reason: Presence of foreign substance: small metallic particles in chewable tablets.
Reason: Presence of foreign substance: small metallic particles in chewable tablets.
Reason: Presence of foreign substance: small metallic particles in chewable tablets.
Reason: Presence of foreign substance: small metallic particles in chewable tablets.
Reason: Presence of foreign substance: small metallic particles in chewable tablets.
Reason: Presence of foreign substance: small metallic particles in chewable tablets.
Reason: Presence of foreign substance: small metallic particles in chewable tablets.
Reason: Presence of foreign substance: small metallic particles in chewable tablets.
Reason: Presence of foreign substance: small metallic particles in chewable tablets.
Reason: Presence of foreign substance: small metallic particles in chewable tablets.
Reason: Product Mix-Up: A bottle containing Voriconazole Tablets 50 mg was labelled and distributed as Aripiprazole Tablets USP 30 mg.
Reason: Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.
Reason: Failed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-hour timepoint.
Reason: Subpotent for Vitamin A. The firm discovered that the testing laboratory used the wrong method when testing for Vitamin A. The test results gave a higher concentration of vitamin A than what is actually in the product.
Reason: Subpotent for Vitamin A. The firm discovered that the testing laboratory used the wrong method when testing for Vitamin A. The test results gave a higher concentration of vitamin A than what is actually in the product.
Reason: Product may be contaminated with Salmonella Typhimurium
Reason: Possible E. Coli O157:H7 Contamination
Reason: Undeclared peanuts
Reason: Ingredient statement declares eggs, but eggs are omitted from the "contains" allergen statement on the product labels.
Reason: Microbial contamination of sterile products
Reason: Undeclared allergen, sesame.
Reason: Ingredient statement declares eggs, but eggs are omitted from the "contains" allergen statement on the product labels.
Reason: Product may be contaminated with Salmonella.
Reason: Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product under the proprietary name Xyvona
Reason: Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product under the proprietary name Xyvona
Reason: Defective container:may contain bottles with incomplete seals
Reason: Defective container:may contain bottles with incomplete seals
Reason: Defective container:may contain bottles with incomplete seals
Reason: Defective container:may contain bottles with incomplete seals
Reason: Defective container:may contain bottles with incomplete seals
Reason: Undeclared colors (FD&C Yellow 5 and FD&C Red 40).
Reason: Defective container:may contain bottles with incomplete seals
Reason: Defective container:may contain bottles with incomplete seals
Reason: cGMP deviations
Reason: Contains undeclared allergen (shrimp).
Reason: Lack of Assurance of Sterility
Reason: Subpotent Drug
Reason: Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan
Reason: Potential for Salmonella
Reason: Product tested positive for Salmonella
Reason: Potential for Salmonella
Reason: Undeclared Tree Nut Allergen
Reason: Failed Stability Specifications
Reason: Foreign material (Glass) was found in the product.
Reason: Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
Reason: Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
Reason: Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
Reason: Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
Reason: Potential contamination with lead.
Reason: Failed Impurities/Degradations Specifications
Reason: Imported Enoki Mushrooms samples collected by Florida Department of Health tested positive for Listeria Monocytogenes.
Reason: CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.
Reason: Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.
Reason: Undeclared Allergen (Soy)
Reason: Un-eviscerated fish may be contaminated with clostridium botulinum
Reason: Potential contamination with foreign objects (metal pieces).
Reason: Potential contamination with foreign objects (metal pieces).
Reason: Potential contamination with foreign objects (metal pieces).
Reason: Potential contamination with foreign objects (metal pieces).
Reason: Presence of Particulate matter: Particulate matter identified as glass.
Reason: Lack of Assurance of Sterility
Reason: Subpotent Drug
Reason: Undeclared melatonin.
Reason: Potential contamination with foreign objects (metal pieces).
Reason: Defective Container; packets were found to be either empty or partially full.
Reason: Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling.
Reason: Imported Enoki Mushrooms tested positive for Listeria Monocytogenes.
Reason: Possible Listeria monocytogenes contamination
Reason: Lack of Assurance of Sterility
Reason: Sesame Seeds White were labeled as Curry Powder Sweet.
Reason: Foreign object: black particulate matter
Reason: Undeclared Sesame allergen
Reason: Undeclared Sesame allergen
Reason: Undeclared Sesame allergen
Reason: Undeclared Sesame allergen
Reason: Undeclared Sesame allergen
Reason: The product contains unapproved colors chlorophyll E140 and E141.
Reason: Product contains dry milk powder ingredient recalled by the supplier due to potential Salmonella contamination
Reason: Product contains dry milk powder ingredient recalled by the supplier due to potential Salmonella contamination
Reason: Product contains dry milk powder ingredient recalled by the supplier due to potential Salmonella contamination
Reason: The product contains unapproved colors chlorophyll E140 and E141.
Reason: Premature lipid oxidation causing quality issue potentially causing product to have an off odor and bitter taste.
Reason: Product contains dry milk powder ingredient recalled by the supplier due to potential Salmonella contamination
Reason: Potential contamination with Salmonella
Reason: Products were made with recalled California Dairies milk powder due to Salmonella.
Reason: potential presence of Salmonella
Reason: potential presence of Salmonella
Reason: potential presence of Salmonella
Reason: potential presence of Salmonella
Reason: potential presence of Salmonella
Reason: Product may be contaminated with Salmonella.
Reason: potential presence of Salmonella
Reason: Products were made with recalled California Dairies milk powder due to Salmonella.
Reason: Products were made with recalled California Dairies milk powder due to Salmonella.
Reason: Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications
Reason: May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.
Reason: May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.
Reason: May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.
Reason: May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.
Reason: May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.
Reason: May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.
Reason: May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.
Reason: May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.
Reason: May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.
Reason: May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.
Reason: Misbranding and Undeclared Allergens
Reason: May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.
Reason: May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.
Reason: May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.
Reason: May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.
Reason: May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.
Reason: May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.
Reason: Failed Impurities/Degradation Specifications
Reason: Products may be potentially contaminated with Salmonella.
Reason: Products may be potentially contaminated with Salmonella.
Reason: Products may be potentially contaminated with Salmonella.
Reason: Products may be potentially contaminated with Salmonella.
Reason: Products may be potentially contaminated with Salmonella.
Reason: Products may be potentially contaminated with Salmonella.
Reason: Products may be potentially contaminated with Salmonella.
Reason: Presence of a Foreign Substance; black particles observed in liquid
Reason: Products may be potentially contaminated with Salmonella.
Reason: Products may be potentially contaminated with Salmonella.
Reason: Products may be potentially contaminated with Salmonella.
Reason: Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Reason: Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Reason: Salmonella. The firm was notified by the North Carolina Department of Agriculture that the product test positive for Salmonella.
Reason: Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule.
Reason: Possible Salmonella Contamination
Reason: The firm is recalling sunflower seed products due to the presence of an undeclared tree nut allergen, cashew.
Reason: The firm is recalling sunflower seed products due to the presence of an undeclared tree nut allergen, cashew.
Reason: The firm is recalling sunflower seed products due to the presence of an undeclared tree nut allergen, cashew.
Reason: The firm is recalling sunflower seed products due to the presence of an undeclared tree nut allergen, cashew.
Reason: The firm is recalling sunflower seed products due to the presence of an undeclared tree nut allergen, cashew.
Reason: The firm is recalling sunflower seed products due to the presence of an undeclared tree nut allergen, cashew.
Reason: CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
Reason: CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
Reason: CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
Reason: CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
Reason: CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
Reason: Potential presence of Salmonella.
Reason: Potential presence of Salmonella.
Reason: Potential presence of Salmonella.
Reason: Potential presence of Salmonella.
Reason: Potential presence of Salmonella.
Reason: Potential presence of Salmonella.
Reason: Presence of Particulate Matter.
Reason: Undeclared walnuts
Reason: Lack of Assurance of Sterility: The recall is being initiated out of an abundance of caution following FDA observations noted during a recent inspection of Excelvision.
Reason: Failed Dissolution Specifications
Reason: Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Reason: Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Reason: Potential contamination with Salmonella.
Reason: Potential contamination with Salmonella.
Reason: Potential contamination with Salmonella.
Reason: Potential contamination with Salmonella.
Reason: Potential contamination with Salmonella.
Reason: Potential contamination with Salmonella.
Reason: Potential contamination with Salmonella.
Reason: Potential contamination with Salmonella.
Reason: Potential contamination with Salmonella.
Reason: Potential contamination with Salmonella.
Reason: potential to be contaminated with Salmonella
Reason: potential to be contaminated with Salmonella
Reason: potential to be contaminated with Salmonella
Reason: potential to be contaminated with Salmonella
Reason: potential to be contaminated with Salmonella
Reason: potential to be contaminated with Salmonella
Reason: potential to be contaminated with Salmonella
Reason: potential to be contaminated with Salmonella
Reason: potential to be contaminated with Salmonella
Reason: potential to be contaminated with Salmonella
Reason: Presence of particulate matter: a white thread-like structure in the cartridge
Reason: Microbial Contamination of Non-Sterile Products: confirmed presence of Staphylococcus Aureus.
Reason: Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Reason: Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Reason: Undeclared nut allergen (walnut) due to mislabeling. The product's printed tasting guide incorrectly identifies the Walnut Fudge and Peach Cobbler flavor chocolates (bonbons). Consumers relying on the printed materials could mistakenly consume a nut-containing bonbon.
Reason: Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test
Reason: Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
Reason: Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
Reason: Product was made with milk powder recalled by the supplier due to Salmonella contamination.
Reason: Product was made with milk powder recalled by the supplier due to Salmonella contamination.
Reason: Product was made with milk powder recalled by the supplier due to Salmonella contamination.
Reason: Product was made with milk powder recalled by the supplier due to Salmonella contamination.
Reason: Product was made with milk powder recalled by the supplier due to Salmonella contamination.
Reason: Product was made with milk powder recalled by the supplier due to Salmonella contamination.
Reason: Lack of assurance of Sterility: potential product contamination
Reason: Lack of assurance of Sterility: potential product contamination
Reason: Firm received and used potentially contaminated (Salmonella) ingredient to manufacture various products.
Reason: CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Reason: Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
Reason: Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
Reason: Contains undeclared allergens (cashews, milk, and soy).
Reason: Potential contamination with Salmonella.
Reason: Potential contamination with Salmonella.
Reason: Potential contamination with Salmonella.
Reason: Chemical contamination; presence of lead and lithium above specification
Reason: Lack of Assurance of Sterility
Reason: Lack of Assurance of Sterility
Reason: Labeling: Missing Label
Reason: Undeclared Yellow #5
Reason: Undeclared Milk, Soy, Red #40.
Reason: Undeclared Milk, Red #40.
Reason: Undeclared Soy (with mitigating circumstances)
Reason: Undeclared Milk, Wheat, Soy, Yellow #5, Green #3.
Reason: Undeclared Milk, Walnuts, Eggs, Wheat, Soy.
Reason: Undeclared Red #40, Blue #1, Blue #2
Reason: Undeclared Milk, Eggs, Yellow #5.
Reason: Undeclared Milk, Red #3, Red #40, Blue #1, Blue #2.
Reason: Undeclared Red #40
Reason: Undeclared Milk, Almonds, Soy, Sulfites.
Reason: Undeclared Milk.
Reason: Undeclared Milk.
Reason: Undeclared Milk, Peanuts.
Reason: Undeclared Milk, Yellow #5.
Reason: Undeclared Milk, Pistachios, Yellow #5, Blue #1.
Reason: Undeclared Soy (with mitigating circumstances), Yellow #5, Blue #1
Reason: Undeclared Milk, Pecans.
Reason: Undeclared Milk, Eggs, Yellow #5.
Reason: Undeclared Milk, Walnuts, Eggs.
Reason: Undeclared Milk, Soy.
Reason: Undeclared Milk, Yellow #5.
Reason: Undeclared Milk, Yellow #6.
Reason: Undeclared Milk, Soy, Sulfites.
Reason: Undeclared Milk, Red #40.
Reason: Undeclared Milk.
Reason: Undeclared Milk, Almonds, Soy.
Reason: Undeclared Milk.
Reason: Undeclared Milk, Cashews, Soy, Sulfites.
Reason: Undeclared Milk, Soy, Yellow #5, Red #40, Green #3.
Reason: Undeclared Milk, Almonds.
Reason: Undeclared Milk, Yellow #5.
Reason: Undeclared Milk, Red #40, Blue #1.
Reason: Undeclared Milk, Walnuts, Sulfites.
Reason: Undeclared Milk, Almonds, Soy.
Reason: Undeclared Milk, Red #40, Blue #1.
Reason: Undeclared Milk, Soy.
Reason: Undeclared Milk, Soy, Yellow #5, Blue #1.
Reason: Labeling: Incorrect or Missing Lot and/or Exp Date:The expiration date has an extra digit and is printed as 2709114 instead of the correct 270914 (2027-09-14). It is important to note that this error is limited to the vial itself; the saleable unit of the box of 12 bottles has the correct expiration date printed.
Reason: Subpotent drug
Reason: Misbranding and Undeclared Allergen
Reason: Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.
Reason: CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Reason: CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Reason: Microbial contamination of Non-Sterile Product: samples identified the presence of Lysinibacillus fusiformis and other Bacillus spp
Reason: CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Reason: CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminated
Reason: CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Reason: CGMP Deviations: product manufactured in the same facility under the same conditions as the product found to be contaminated
Reason: CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Reason: Defective container: defect in a batch of bottle caps, specifically involving dislodged or missing cap liners.
Reason: This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.
Reason: Failed PH Specifications
Reason: May be under-processed resulting in growth of Clostridium botulinum and lists health claims.
Reason: May be under-processed resulting in growth of Clostridium botulinum and lists health claims.
Reason: May be under-processed resulting in growth of Clostridium botulinum and lists health claims.
Reason: May be under-processed resulting in growth of Clostridium botulinum and lists health claims.
Reason: May be under-processed resulting in growth of Clostridium botulinum and lists health claims.
Reason: May be under-processed resulting in growth of Clostridium botulinum and lists health claims.
Reason: May be under-processed resulting in growth of Clostridium botulinum and lists health claims.
Reason: May be under-processed resulting in growth of Clostridium botulinum and lists health claims.
Reason: May be under-processed resulting in growth of Clostridium botulinum and lists health claims.
Reason: May be under-processed resulting in growth of Clostridium botulinum and lists health claims.
Reason: May be under-processed resulting in growth of Clostridium botulinum and lists health claims.
Reason: May be under-processed resulting in growth of Clostridium botulinum and lists health claims.
Reason: Updated Laboratory Result
Reason: May be under-processed resulting in growth of Clostridium botulinum and lists health claims.
Reason: Lack of Assurance of Sterility: Potential leaks from perforations in bags.
Reason: Lack of Assurance of Sterility: Potential leaks from perforations in bags.
Reason: Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
Reason: Foreign object (stainless steel dust/flakes or shreds of plastic)
Reason: Foreign object (stainless steel dust/flakes or shreds of plastic)
Reason: Foreign object (stainless steel dust/flakes or shreds of plastic)
Reason: Foreign object (stainless steel dust/flakes or shreds of plastic)
Reason: Foreign object (stainless steel dust/flakes or shreds of plastic)
Reason: Potential contamination with foreign materials.
Reason: Creamed honey products may contain stainless steel dust/flakes and/or small particles or shreds of plastic.
Reason: Creamed honey products may contain stainless steel dust/flakes and/or small particles or shreds of plastic.
Reason: Creamed honey products may contain stainless steel dust/flakes and/or small particles or shreds of plastic.
Reason: Creamed honey products may contain stainless steel dust/flakes and/or small particles or shreds of plastic.
Reason: Creamed honey products may contain stainless steel dust/flakes and/or small particles or shreds of plastic.
Reason: Creamed honey products may contain stainless steel dust/flakes and/or small particles or shreds of plastic.
Reason: Creamed honey products may contain stainless steel dust/flakes and/or small particles or shreds of plastic.
Reason: Creamed honey products may contain stainless steel dust/flakes and/or small particles or shreds of plastic.
Reason: Undeclared Milk Allergen,
Reason: Undeclared Milk Allergen,
Reason: Undeclared Milk Allergen,
Reason: Undeclared Milk Allergen,
Reason: Multi-state outbreak of E. coli O157:H7.
Reason: Multi-state outbreak of E. coli O157:H7.
Reason: Multi-state outbreak of E. coli O157:H7.
Reason: Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Reason: Multi-state outbreak of E. coli O157:H7.
Reason: Multi-state outbreak of E. coli O157:H7.
Reason: Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Reason: Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Reason: Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Reason: Lack of Assurance of Sterility
Reason: Lack of Assurance of Sterility
Reason: Lack of Assurance of Sterility
Reason: Lack of Assurance of Sterility
Reason: Lack of Assurance of Sterility
Reason: cGMP deviations.
Reason: cGMP deviations.
Reason: cGMP deviations.
Reason: cGMP deviations.
Reason: cGMP deviations.
Reason: cGMP deviations.
Reason: cGMP deviations.
Reason: Failed Stability Specifications
Reason: Subpotent drug
Reason: cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
Reason: cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
Reason: cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
Reason: Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots."
Reason: Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
Reason: Produced without federal inspection
Reason: Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
Reason: Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
Reason: Lack of Assurance of Sterility
Reason: Potential contamination with pesticides, haloxyfop and thiamethoxam
Reason: Potential contamination with pesticides, haloxyfop and thiamethoxam
Reason: Potential contamination with pesticides, haloxyfop and thiamethoxam
Reason: Failed Dissolution Specifications
Reason: Presence of particulate matter
Reason: Presence of particulate matter
Reason: Possible Foreign Material Contamination
Reason: Undeclared allergen (soy lecithin).
Reason: Marketed Without an Approved NDA/ANDA: Product contains undeclared drug ingredients dexamethasone and cyproheptadine.
Reason: This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Reason: Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Reason: CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.
Reason: This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Reason: This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Reason: This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Reason: This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Reason: This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Reason: This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Reason: This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Reason: This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Reason: This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Reason: This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Reason: This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Reason: This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Reason: This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Reason: This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Reason: Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Reason: Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Reason: Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Reason: Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Reason: CGMP Deviations: use of an unapproved raw material
Reason: CGMP Deviations: use of an unapproved raw material
Reason: CGMP Deviations: use of an unapproved raw material
Reason: Failed Impurities/Degradation Specifications: N-nitroso-desmethyl-tramadol impurity (NDSRI) was found out of the specification at 24-month stability interval during Long term stability (25¿C/60%RH).
Reason: Product mix up: a foil pouch labeled "Magnesium Sulfate in Water for Injection, 4 g/100 mL" actually contained an IV bag of Tranexamic Acid instead.
Reason: Lack of Assurance of Sterility
Reason: Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Reason: Labelling: Illegible label
Reason: Failed Dissolution Specifications
Reason: Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Reason: Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Reason: CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
Reason: CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
Reason: CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
Reason: Failed tablet specifications.
Reason: Crystallization; identified as Buprenorphine free base
Reason: Misbranding
Reason: Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.
Reason: Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.
Reason: Product does not meet label claim for Vitamin E.
Reason: Potential Salmonella contamination. The firm was notified from their supplier that the nonfat dry milk may be contaminated with Salmonella.
Reason: Potential Salmonella contamination. The firm was notified from their supplier that the nonfat dry milk may be contaminated with Salmonella.
Reason: Lack of Assurance of Sterility
Reason: Lack of Assurance of Sterility
Reason: Lack of Assurance of Sterility
Reason: Lack of Assurance of Sterility
Reason: Lack of Assurance of Sterility
Reason: Lack of Assurance of Sterility
Reason: Lack of Assurance of Sterility
Reason: Lack of Assurance of Sterility
Reason: Lack of Assurance of Sterility
Reason: Lack of Assurance of Sterility
Reason: Lack of Assurance of Sterility
Reason: Lack of Assurance of Sterility
Reason: Lack of Assurance of Sterility
Reason: Lack of Assurance of Sterility
Reason: Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.
Reason: Lack of Assurance of Sterility
Reason: Lack of Assurance of Sterility
Reason: Chemical contamination: Presence of benzene
Reason: Lack of Assurance of Sterility
Reason: Lack of Assurance of Sterility
Reason: Lack of Assurance of Sterility
Reason: Possible Foreign Matter Contamination
Reason: Chemical contamination: Presence of benzene
Reason: Chemical contamination: Presence of benzene
Reason: Chemical contamination: Presence of benzene
Reason: Lack of Assurance of Sterility
Reason: Lack of Assurance of Sterility
Reason: Lack of Assurance of Sterility
Reason: Lack of Assurance of Sterility
Reason: Lack of Assurance of Sterility
Reason: Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing
Reason: Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product.
Reason: Non-Sterility: microbial contamination identified as Paenibacillus phoenicis
Reason: Misbranding and Undeclared Allergen
Reason: Subpotent Drug
Reason: Lack of Assurance of Sterility
Reason: Lack of Assurance of Sterility
Reason: Lack of Assurance of Sterility
Reason: Lack of Assurance of Sterility
Reason: Failed Dissolution Specifications
Reason: Possible Foreign Matter Contamination
Reason: Failed Tablet/Capsule Specifications
Reason: Possible Foreign Matter Contamination
Reason: Import violation
Reason: Stability Data Does Not Support Expiry Date.
Reason: Stability Data Does Not Support Expiry Date.
Reason: Stability Data Does Not Support Expiry Date.
Reason: Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
Reason: Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
Reason: Defective container; inadequately sealed blister packaging.
Reason: CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution
Reason: CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution
Reason: Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution.
Reason: Labeling: Not Elsewhere Classified. The carton for Eptifibatide Injection 75 mg/100 mL states 75 mg/100 mL vial for weight-adjusted bolus dosing. The approved statement is 75 mg/100 mL vial for weight-adjusted infusion.
Reason: Possible E. coli contamination
Reason: Lack of Assurance of Sterility: due to the presence of particulate matter in one unit from the lot, which lab tests have identified as wool fiber.
Reason: Defective Delivery System: Missing or duplicated needles within the injection kit
Reason: Lack of Assurance of Sterility
Reason: Lack of Assurance of Sterility
Reason: Lack of Assurance of Sterility
Reason: Lack of Assurance of Sterility
Reason: Lack of Assurance of Sterility
Reason: Failed Impurities/Degradation Specifications - OOS impurities result observed during long term stability testing at product expiry (24 months) were above specs for these impurities: Dexamethasone Sodium Phosphate EP impurity G (Impurity RU 49336) and dexamethasone formate.
Reason: Import violation
Reason: Presence of foreign tablets/capsules: one Pitavastatin tablet 1mg found in bottle of Pitavastatin tablets 2mg
Reason: cGMP deviations
Reason: cGMP deviations
Reason: Undeclared Egg Allergen
Reason: Failed Dissolution Specifications
Reason: Failed Dissolution Specifications
Reason: Failed Dissolution Specifications
Reason: Failed Dissolution Specifications
Reason: Undeclared tadalafil
Reason: Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] result in viscosity for Diclofenac Sodium Gel, 3%.
Reason: Presence of Foreign substance - potential presence of metal particulate matter
Reason: Presence of Foreign substance - potential presence of metal particulate matter
Reason: Presence of Foreign substance - potential presence of metal particulate matter
Reason: Presence of Foreign substance - potential presence of metal particulate matter
Reason: Presence of Foreign substance - potential presence of metal particulate matter
Reason: Presence of Foreign substance - potential presence of metal particulate matter
Reason: Presence of Foreign substance - potential presence of metal particulate matter
Reason: Presence of Foreign substance - potential presence of metal particulate matter
Reason: Presence of Foreign substance - potential presence of metal particulate matter
Reason: Presence of Foreign substance - potential presence of metal particulate matter
Reason: Presence of Foreign substance - potential presence of metal particulate matter
Reason: Presence of Foreign substance - potential presence of metal particulate matter
Reason: Presence of Foreign substance - potential presence of metal particulate matter
Reason: Presence of Foreign substance - potential presence of metal particulate matter
Reason: Presence of Foreign substance - potential presence of metal particulate matter
Reason: Presence of Foreign substance - potential presence of metal particulate matter
Reason: Presence of Foreign substance - potential presence of metal particulate matter
Reason: Presence of Foreign substance - potential presence of metal particulate matter
Reason: Presence of Foreign substance - potential presence of metal particulate matter
Reason: Presence of Foreign substance - potential presence of metal particulate matter
Reason: Presence of Foreign substance - potential presence of metal particulate matter
Reason: Presence of Foreign substance - potential presence of metal particulate matter
Reason: Presence of Foreign Tablets/Capsules
Reason: Presence of Foreign substance - potential presence of metal particulate matter
Reason: Presence of Foreign substance - potential presence of metal particulate matter
Reason: Presence of Particulate Matter: Due to production issues
Reason: Presence of Foreign substance - potential presence of metal particulate matter
Reason: Tablets/Capsules Imprinted with Wrong ID
Reason: cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.
Reason: CGMP Deviations
Reason: CGMP Deviations
Reason: CGMP Deviations
Reason: CGMP Deviations
Reason: CGMP Deviations
Reason: CGMP Deviations
Reason: CGMP Deviations
Reason: CGMP Deviations
Reason: CGMP Deviations
Reason: CGMP Deviations
Reason: CGMP Deviations
Reason: CGMP Deviations
Reason: CGMP Deviations
Reason: CGMP Deviations
Reason: CGMP Deviations
Reason: CGMP Deviations
Reason: CGMP Deviations
Reason: CGMP Deviations
Reason: CGMP Deviations
Reason: CGMP Deviations
Reason: CGMP Deviations
Reason: Subpotent Drug
Reason: Possible Listeria Contamination
Reason: Temperature Abuse. 116 cartons with specific serial numbers of Lot 2199821, were stored incorrectly in a controlled room temperature environment instead of the required refrigerated environment.
Reason: Labeling: Not Elsewhere Classified. Incorrect orientation of the blister foil applied to the blister cavities, which results in incorrect dosing information when following the directions on the foil.
Recall information comes directly from federal agencies and can change as investigations continue. Always check the official notice for the most current guidance, and contact your doctor or pharmacist before stopping a recalled medication.