FDA raises thyroid tablet recall to Class I, its most serious risk level
The FDA has classified Vitruvias Therapeutics' recalled lot of 30 mg thyroid tablets as a Class I recall — its most serious category — after tests showed the tablets could be superpotent.
The US Food and Drug Administration has categorised a nationwide recall of Vitruvias Therapeutics thyroid tablets as a Class I recall, its most serious risk level, after testing confirmed the tablets had the potential to be “superpotent”.
Vitruvias Therapeutics Inc., of Auburn, Alabama, voluntarily recalled one lot of Thyroid Tablets, USP 30 mg, at the consumer level.
The affected lot is identified as NDC 69680-166-00, Lot No. 504950, with an expiration date of 30 September 2026. About 3,655 units were released, with roughly 1,955 sold and distributed nationwide to direct accounts between 31 January 2025 and 30 September 2025.
Superpotent thyroid tablets can trigger hyperthyroidism, with symptoms including weight loss, heat intolerance, fatigue, nervousness, muscle weakness, hypertension, chest pain, and rapid heart rate or rhythm disturbances. The FDA warns that elderly people, pregnant women and infants are at greatest risk.
As of the FDA’s 24 August 2026 company announcement, Vitruvias had received no reports of adverse events known to be related to the recall. Anyone taking the recalled tablets should not stop without first contacting their health care provider, and can reach the company at safety@vitruvias.com or 256-239-9373.
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