Key Takeaway:
- Vitruvias recalled one lot of 30 mg thyroid tablets nationwide over potential superpotency concerns.
- Affected products: Lot No. 504950, NDC 69680-166-00, expiring Sept. 30, 2026.
- Patients should not stop treatment on their own and should contact their health care provider for guidance.
Vitruvias Therapeutics Inc. is recalling one lot of 30 mg thyroid tablets nationwide after testing found they could be superpotent, the FDA said Aug. 24, potentially exposing patients to excessive thyroid hormone in the latest thyroid tablets recall to draw federal scrutiny.
FDA identifies recalled thyroid tablets
The recall covers Thyroid Tablets, USP 30 mg, lot No. 504950, with National Drug Code 69680-166-00 and an expiration date of Sept. 30, 2026. The affected lot was distributed nationwide in the United States from Jan. 31 through Sept. 30, 2025.
Vitruvias released 3,655 units of the affected lot, with 1,955 sold, according to the FDA notice. The company is voluntarily recalling the product to the consumer level and has notified wholesalers to stop distributing it.
The FDA listed the recall Aug. 24 after the company announced it Aug. 21. The agency said the recall is being conducted with its knowledge.
Superpotency may cause health problems
Testing confirmed the tablets have the potential to contain more thyroid hormone than intended. Taking superpotent thyroid tablets can cause hyperthyroidism, or an overactive thyroid, according to the FDA.
Possible effects include weight loss, heat intolerance, fatigue, nervousness, muscle weakness, high blood pressure, chest pain, rapid heart rate, and heart rhythm disturbances. The FDA said older adults, pregnant women and infants face greater risks, particularly with prolonged exposure.
“Consumption of superpotent Thyroid tablets can cause hyperthyroidism,” the FDA notice says, warning that excessive thyroid hormone can have serious effects on the heart and other body systems.
Thyroid, USP is a natural thyroid preparation derived from porcine thyroid glands. It contains levothyroxine and liothyronine and is used to treat hypothyroidism, or an underactive thyroid, the condition this thyroid tablets recall is meant to safely treat.
Patients should contact their providers
Vitruvias said it has not received reports of adverse events known to be related to the recalled lot, according to the FDA. Patients taking the affected tablets should not stop treatment without first contacting their health care provider for guidance or a replacement prescription.
Consumers with questions can contact Vitruvias Therapeutics at safety@vitruvias.com or 256-239-9373, Monday through Friday from 9 a.m. to 5 p.m. Central Time. The FDA also advises people who experience problems that may be related to the medicine to contact their health care provider and report adverse reactions through its MedWatch program. Anyone affected by this thyroid tablets recall should confirm their lot number before altering their routine.
