Key Takeaway:
- One lot recalled: Vitruvias Therapeutics recalled thyroid tablets, USP 30 mg, lot 504950, over potential superpotency.
- Health risks: Excess thyroid hormone may cause hyperthyroidism, including rapid heartbeat, high blood pressure, chest pain, and weight loss.
- What patients should do: Check the lot number and contact a health care provider before stopping the medication.
The Food and Drug Administration and Vitruvias Therapeutics Inc. are recalling one lot of thyroid tablets nationwide as part of a Thyroid Drug Recall after the company found the product could be “superpotent,” potentially causing dangerous hyperthyroidism.
Company recalls one lot of thyroid tablets
Vitruvias Therapeutics said Monday it is recalling thyroid tablets, USP 30 mg, with lot number 504950. The tablets were distributed nationwide to the company’s direct accounts from Jan. 31, 2025, through Sept. 30, 2025.
About 1,955 units from the recalled lot were sold, according to the company. Vitruvias said it is contacting wholesalers by email and phone to stop distribution and arrange for the recalled products to be destroyed, a process guided by pharmaceutical regulatory compliance standards.
The FDA said consuming tablets with excessive thyroid hormone can cause hyperthyroidism, or an overactive thyroid. The condition can produce symptoms including weight loss, heat intolerance, fatigue, nervousness, muscle weakness, high blood pressure, chest pain, rapid heartbeat, and abnormal heart rhythms.
Vitruvius said it has received no reports of adverse reactions related to the recalled lot as of Monday.
Excess thyroid hormone can cause serious symptoms
The recalled medication is a natural thyroid preparation derived from porcine thyroid glands. It contains levothyroxine and liothyronine and is used to treat hypothyroidism, a condition in which the thyroid does not produce enough hormones.
The company described the affected tablets in this Thyroid Drug Recall as potentially “superpotent,” meaning they could contain more thyroid hormone than intended. Excessive thyroid hormone can place additional strain on the heart and other body systems.
According to the recall notice, elderly people, pregnant women, and infants face greater risks, particularly when excessive thyroid hormone is consumed over an extended period.
Patients who have the recalled lot should not stop taking their medication on their own, Vitruvius said. Instead, they should contact their health care provider for guidance about whether they should continue treatment or switch to another product.
Patients should check lot number before use
Consumers who have thyroid tablets, USP 30 mg should check the packaging for lot number 504950. The recall applies specifically to that lot.
The company said questions about the recall can be directed to Vitruvias Therapeutics at safety@vitruvias.com or 256-239-9373, Monday through Friday from 9 a.m. to 5 p.m. Central Time.
The FDA advises consumers and health care professionals to report suspected adverse reactions associated with medications through its MedWatch program. Patients experiencing symptoms consistent with excessive thyroid hormone exposure should seek medical advice.
Vitruvias said its wholesale customers are being instructed to discontinue distribution of the recalled product and destroy affected inventory.
This Thyroid Drug Recall highlights the importance of checking medication packaging when a drug is subject to a safety alert, particularly for medicines that affect hormone levels and require careful dosing.
