FDA: Use of Thyroid Drug May Cause Serious Harm, Death

A batch of thyroid pills just got slapped with the FDA's most serious recall label. Regulators have upgraded last month's recall of one lot of 30-milligram "Thyroid Tablets, USP" from Vitruvias Therapeutics Inc. to a Class I recall, meaning that use of the drug could lead to serious harm or death, reports USA Today. Testing found the tablets may be overly strong, raising the risk of an overactive thyroid and symptoms such as weight loss, heat intolerance, fatigue, and high blood pressure.

The affected lot—number 504950, National Drug Code number 69680-166-00—includes about 3,600 units (roughly 1,900 already distributed) shipped nationwide between Jan. 31 and Sept. 30, 2025, with an expiration date of Sept. 30 of this year. No adverse events had been reported as of the Aug. 24 recall notice.

Health.com notes that those at the greatest risk from taking superpotent thyroid meds include pregnant patients, the elderly, and infants. The FDA advises patients not to stop taking the medication abruptly but to contact their health care provider for instructions. Questions can be directed to Vitruvias by emailing safety@vitruvias.com or by calling 256-239-9373. (In July, thyroid meds were recalled for being subpotent.)