Thyroid medicine recall receives FDA's highest risk level

The U.S. Food and Drug Administration has upgraded a thyroid medicine recall to Class I—the agency’s highest risk level. On Sept. 22, the FDA classified the recall affecting one lot of 30 mg thyroid tablets sold by Vitruvias Therapeutics Inc. as a Class I recall, meaning use is likely to cause serious health effects or death. The recall was initiated last month after testing indicated the tablets could be “superpotent,” or stronger than intended. The notice says thousands of units were distributed nationwide from January through September 2025, with an expiration date in September 2026, and about 1,900 units were sold from a batch of roughly 3,600. The lot is identified by NDC 69680-166-00 and lot number 504950.