The FDA upgraded Vitruvias Therapeutics’ voluntary recall to a Class I warning after one lot of Thyroid Tablets, USP 30 mg was found to be "superpotent." The recall affects lot 504950 (distributed Jan. 31–Sept. 30, 2025; expires Sept. 30, 2026), with about 1,900 units sold. Excess thyroid hormone can cause hyperthyroidism and pose greater risks for older adults, pregnant people and infants. Patients should consult their healthcare provider before changing or stopping medication.
FDA Elevates Vitruvias Thyroid Tablet Recall to Class I After ‘Superpotent’ Finding
Stock photo of pills spilling out of bottle.Credit: Getty
The U.S. Food and Drug Administration (FDA) has upgraded a voluntary recall by Vitruvias Therapeutics, Inc. to a Class I action — the agency's most serious warning — after confirming that one lot of Thyroid Tablets, USP 30 mg was "superpotent." The FDA made the designation on Sept. 22, 2025.
What Was Recalled
The recall applies to lot number 504950, labeled "Thyroid Tablets, USP." According to Vitruvias, the affected tablets were distributed between Jan. 31 and Sept. 30, 2025, and carry an expiration date of Sept. 30, 2026. From an original batch of about 3,600 units, roughly 1,900 units were sold.
Why This Matters
Vitruvias says the tablets may contain a higher concentration of active thyroid hormone than intended. Taking an overconcentrated ("superpotent") tablet can cause hyperthyroidism, an overactive thyroid condition. Symptoms may include weight loss, heat intolerance, fatigue, nervousness, muscle weakness and abnormal heart rhythms. Prolonged exposure to excess thyroid hormone can worsen cardiac problems and has been linked to maternal, fetal and infant developmental complications.
"To date, Vitruvias Therapeutics has not received any reports of adverse events known to be related to this recall," the company said. (Stock)Credit: Getty
Who Is Most At Risk
The company and health authorities emphasize that older adults, pregnant people and infants are particularly vulnerable to the effects of excess thyroid hormone, especially after extended exposure.
What Patients Should Do
Do not stop or switch your thyroid medication without first consulting the clinician who prescribed it.
If you identify tablets from the recalled lot, contact your prescribing clinician or other healthcare provider for guidance. Consumers who believe they have experienced problems related to this product should notify their physician and report the event to Vitruvias and the FDA as instructed.
Company Statement and Contact
Vitruvias has said it has not received any reports of adverse events known to be related to this recall to date. For questions, consumers can contact Vitruvias Therapeutics, Inc. at [email protected] or by phone at (256) 239-9373.
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