Thyroid Tablet Recall
FDA Upgrades Recall for Superpotent Thyroid Tablets to Most Serious Class I
Anonymous
Key Points
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The recalled product is labeled “Thyroid Tablets, USP” and can be identified by lot number 504950 or National Drug Code 69680-166-00.
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Vitruvias said it notified wholesalers by email and phone to stop distributing the tablets and destroy the recalled product.
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The company warned that overtreatment in infants could negatively affect growth and development; in older adults, high thyroid-hormone levels have been linked to cardiac problems.
The FDA elevated a thyroid medication recall to Class I, its most serious level, after testing found tablets could be dangerously strong. FDA determined that lot 504950 of Vitruvias Therapeutics' 30-mg thyroid tablets poses a reasonable risk of serious health consequences or death. About 1,900 of roughly 3,600 units were sold nationwide in 2025 before the recall.
Overly potent thyroid tablets can trigger hyperthyroidism, causing rapid heartbeat, chest pain, high blood pressure, fatigue and muscle weakness. Pregnant people, infants and older adults face greater danger. Vitruvias Therapeutics reported no adverse events linked to the recall so far, but the company has ceased operations.
How to Identify the Recalled Tablets
The recalled product is labeled Thyroid Tablets, USP with lot number 504950. The National Drug Code is 69680-166-00. Patients who have this specific lot should contact their health care provider for guidance and should not stop treatment without medical advice.
Vitruvias Told Distributors to Destroy Product
Vitruvias notified wholesalers by email and phone to immediately stop distributing the tablets and destroy remaining stock. The company has since ceased operations, with product ownership transferred to H2-Pharma. No adverse events have been reported to date linked to the superpotent tablets.
Greatest Risk to Vulnerable Populations
Infants exposed to excess thyroid hormone may suffer stunted growth and developmental delays. Older adults with high thyroid levels face increased cardiac problems, including irregular heartbeat and heart disease. Vitruvias warned that these groups require immediate medical attention if they took the recalled lot.
What Class I Recall Means
A Class I recall is the FDA's highest warning level, reserved for products that pose serious or life-threatening risks. This designation means there is a reasonable probability of adverse health consequences or death. FDA Class I recalls require immediate action from manufacturers, distributors and patients.
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