Vitruvias Therapeutics thyroid tablet recall: FDA issues serious Class I warning over ‘superpotent’ medicine — check lot number, expiration date and what patients should know

Vitruvias Therapeutics thyroid tablet recall: The US Food and Drug Administration has recalled a thyroid medication over possibility that it’s “superpotent.” The thyroid medicine recall involving Vitruvias Therapeutics has been classified as a 'Class I recall', the most serious recall category. The FDA recall concerns one lot of Thyroid Tablets, USP 30 mg that may be “superpotent,” meaning the tablets could contain more thyroid hormone than intended.

The recall was first announced by Vitruvias Therapeutics in August. Now, the FDA has upgraded the seriousness of the recall for this brand of thyroid medication after the manufacturer ceased operations. A Class I recall means there is a reasonable probability that using or being exposed to the recalled product could cause serious health consequences or death.

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The thyroid medicines are a natural thyroid preparation made from porcine thyroid glands and contain levothyroxine and liothyronine. They are used to treat hypothyroidism, or an underactive thyroid. If the tablets contain too much thyroid hormone, they can cause hyperthyroidism, or an overactive thyroid. The FDA-listed potential symptoms include weight loss, heat intolerance, fatigue, nervousness, muscle weakness, high blood pressure, chest pain, rapid heartbeat and abnormal heart rhythms.

Which Vitruvias thyroid tablets are recalled?

The recall is applicable to one specific lot, not every Vitruvias thyroid tablet. Patients can check their medicine packaging for these details:

• Product: Thyroid Tablets, USP 30 mg
• NDC: 69680-166-00
• Lot number: 504950
• Expiration date: September 30, 2026
• Units released: 3,655
• Units sold: 1,955

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The affected lot was distributed nationwide in the US through Vitruvias Therapeutics' direct accounts between January 31, 2025, and September 30, 2025. According to the FDA notice, elderly, pregnant women and infants are at a much higher risk, especially if they have been exposed for long. Excess thyroid hormone can affect the heart in older adults, while overtreatment during pregnancy has been associated with premature delivery and low birth weight.

What should patients do if they have the recalled tablets?

The FDA has stated that patients who are taking Vitruvias Therapeutics recalled lot should not stop taking the medicine on their own. Patients currently taking Thyroid, USP from Lot 504950 should contact their healthcare provider for guidance and, if needed, a replacement prescription. If someone suddenly stops taking thyroid medication, then it can create health problems, and the right next step can depend on the individual patient.

Vitruvias Therapeutics said it had not received any reports of adverse events known to be related to the recall when the recall notice was published.

Consumers with questions about the Vitruvias Therapeutics thyroid tablet recall can contact the company at safety@vitruvias.com or call (256) 239-9373, Monday through Friday from 9 a.m. to 5 p.m. Central Time. The FDA also directs consumers to its MedWatch program for reporting adverse reactions or quality problems.