vitruvias therapeutics thyroid recall fda

In August 2026, Vitruvias Therapeutics, Inc. initiated a voluntary recall for one lot of Thyroid Tablets, USP 30 mg due to potential superpotency. As of September 24, 2026, the FDA has classified this as a Class I recall, the most serious type, indicating that use of the product could cause serious health consequences or death.

Key Details of the Recall:

• Affected Product: Thyroid Tablets, USP 30 mg.
• Affected Lot Number: 504950 (Expiration Date: September 30, 2026).
• Reason for Recall: Testing confirmed the tablets could be superpotent, meaning they may contain more thyroid hormone than intended. This can lead to hyperthyroidism (overactive thyroid).
• Health Risks: Consuming superpotent thyroid medication can cause symptoms such as rapid or irregular heartbeat, chest pain, nervousness, heat intolerance, weight loss, muscle weakness, and fatigue. These risks are particularly significant for the elderly, pregnant women, and infants.

Recommendations for Patients:

• Do Not Stop Treatment Suddenly: Do not discontinue your medication without first speaking to your healthcare provider. Suddenly stopping thyroid treatment can also lead to health complications.
• Check Your Medication: Look at your prescription bottle to see if the lot number is 504950.
• Contact Your Doctor: If you have the recalled medication, contact your physician or pharmacist to discuss a replacement prescription or guidance on your treatment plan.
• Seek Medical Attention: If you are currently taking this medication and experience concerning symptoms (such as chest pain or a rapid/irregular heartbeat), seek medical care promptly.

Vitruvias Therapeutics has reported that it has ceased operations and transferred its product operations to H2-Pharma. For specific questions, consumers were advised to contact the company via email at safety@vitruvias.com or by phone at (256) 239-9373 (Monday–Friday, 9 a.m. to 5 p.m. CT).