Overview
- The FDA elevated the recall to a Class I designation on Friday, Sept. 25, 2026, meaning there is a reasonable probability that exposure could cause serious health consequences or death.
- The action applies only to Lot 504950 of Thyroid Tablets, USP 30 mg, which were distributed nationwide between Jan. 31, 2025, and Sept. 30, 2025, with roughly 1,955 bottles and 3,655 units released to direct accounts.
- Regulators say the tablets may be “superpotent,” which can cause iatrogenic hyperthyroidism with symptoms such as rapid heart rate, chest pain, high blood pressure, weight loss, nervousness, muscle weakness, and, over time, serious cardiac or developmental harm.
- Vitruvias initiated a voluntary recall in August, is notifying wholesalers to stop distribution and arrange destruction of remaining stock, and has reported no confirmed adverse events tied to the lot so far.
- Patients should check bottle labels for Lot 504950 and not stop thyroid medication on their own; clinicians can provide testing, replacement prescriptions, or adjusted dosing because small changes in hormone dose can cause harm, especially for older adults, pregnant people, and infants.