Vitruvias Therapeutics has voluntarily recalled one lot of 30mg thyroid tablets due to concerns that they may be "superpotent," according to an announcement from the Food and Drug Administration (FDA). The agency stated the recall was initiated because the tablets could potentially contain a higher concentration of active ingredients than intended.
The affected medication is used to treat hypothyroidism, a condition where the thyroid gland is underactive. The FDA reported that consuming tablets from the recalled lot could lead to hyperthyroidism, or an overactive thyroid. Vitruvias Therapeutics has not received any reports of negative health impacts related to the product at this time.
The recall involves lot 504950, which includes 3,655 units released for distribution, of which 1,955 were sold. The lot was distributed to the company’s direct accounts nationwide between January 31 and September 30, 2025. The company is currently instructing wholesalers to stop distribution and arrange for the destruction of the recalled product.
For the individuals using this medication, the recall could lead to immediate changes in health monitoring. The FDA noted that symptoms of hyperthyroidism from these tablets may include a rapid heart rate, heart rhythm disturbances, chest pain, hypertension, nervousness, and heat intolerance. Patients who possess medication from lot 504950 are advised not to stop taking the drug immediately, as sudden discontinuation of thyroid treatment can have health effects; instead, they are instructed to consult their healthcare provider to determine the next steps for their treatment plan.
The recall sets a requirement for wholesalers and distributors to remove the specific lot from the supply chain to prevent further sales. Consumers can contact Vitruvias Therapeutics via email or phone during standard business hours for questions regarding the recall. The FDA has not announced a specific deadline for the destruction of the product, but the company has already begun the notification process for its accounts to ensure the affected tablets are secured.