The FDA raised Vitruvias’ recall of Thyroid Tablets, USP 30 mg, to Class I after tests found possible excess potency. It covers lot 504950 and about 3,655 units distributed nationwide; Class I signals a reasonable probability of serious harm or death.
Lot 504950 was supplied to Vitruvias Therapeutics’ direct accounts nationwide from Jan. 31 through Sept. 30, 2025; the tablets expire Sept. 30, 2026. Thyroid, USP is used to treat hypothyroidism. Overpotent tablets can cause an overactive thyroid, with symptoms including rapid heartbeat, chest pain, weakness and nervousness. The FDA says older adults, pregnant women and infants face greater risk.
As of Aug. 24, no injuries or deaths had been reported. Vitruvias said patients should not stop taking the tablets without first contacting a health care provider for guidance or a replacement prescription. Patients experiencing adverse effects should contact a provider and report them to FDA MedWatch. The company is contacting wholesalers to ensure the recalled tablets are destroyed.
