Archive · 24 Sep 2026
FDA Upgrades Recall of Potentially Superpotent Thyroid Tablets
The FDA raised the risk level of a recall involving some thyroid medicine.
The affected medicine may contain more thyroid hormone than it should.
This could make a person’s thyroid work too fast.
Possible problems include a fast heartbeat, chest pain, high blood pressure, and unusual heart rhythms.
Older people may face especially serious heart-related problems.
Pregnant women and babies may also be harmed if they receive too much thyroid hormone for a long time.
The recalled product comes from one lot, numbered 504950.
People with that lot should talk to a healthcare provider before stopping or replacing it.
Vitruvias Therapeutics said it had not received reports of related adverse events when the original recall notice was issued.
The FDA classified Vitruvias Therapeutics’ recall as Class I after testing found one thyroid-tablet lot could contain excessive hormone.
The affected Thyroid Tablets, USP 30 mg lot is 504950, with National Drug Code 69680-166-00 and an expiration date of September 30, 2026.
About 3,655 units were distributed nationwide between January 31 and September 30, 2025; roughly 1,955 were sold.
Excess thyroid hormone may cause weight loss, heat intolerance, fatigue, high blood pressure, chest pain, rapid heartbeat, and heart-rhythm disturbances.
Elderly patients, pregnant women, and infants face the greatest risks; patients should continue taking the tablets until consulting a healthcare provider.
- Who
- The U.S. Food and Drug Administration, Vitruvias Therapeutics, and patients using the affected thyroid tablets.
- What
- The FDA upgraded the recall classification for one lot of Vitruvias Therapeutics’ Thyroid Tablets, USP 30 mg, because the tablets may be superpotent.
- When
- The tablets were distributed from January 31 through September 30, 2025; the original recall notice was issued in August, and the product expires September 30, 2026.
- Where
- The affected tablets were distributed nationwide in the United States.
- Why
- Testing found the tablets could contain excessive thyroid hormone, potentially causing an overactive thyroid and serious health consequences.
- Recall classification
- Class I, which the FDA says means use could reasonably cause serious adverse health consequences or death.
- Product
- Vitruvias Therapeutics Thyroid Tablets, USP 30 mg.
- Affected lot
- Lot 504950; National Drug Code 69680-166-00.
- Expiration date
- September 30, 2026.
- Distribution
- Approximately 3,655 units distributed; about 1,955 sold.
- Highest-risk groups
- Elderly patients, pregnant women, and infants.
- Consumer guidance
- Continue taking tablets from the affected lot until speaking with a healthcare provider about next steps or a replacement prescription.
- Company contact
- [email protected] or (256) 239-9373.