Overview
- The FDA upgraded the recall to its highest Class I level on Sept. 22, 2026 after Vitruvias’ testing identified Lot 504950 as potentially superpotent and the company had issued a voluntary recall in August.
- The recall covers Thyroid Tablets, USP 30 mg (NDC 69680-166-00), lot 504950, which were distributed nationwide from Jan. 31 to Sept. 30, 2025 and expire Sept. 30, 2026.
- About 3,655 units were released from the lot and roughly 1,955 were sold before the defect was found, according to company and FDA records.
- These tablets contain both levothyroxine (T4) and liothyronine (T3) so excess potency can trigger overactive thyroid symptoms such as rapid heartbeat, chest pain, high blood pressure, weight loss and dangerous heart rhythm problems, with highest risk to older adults, pregnant people and infants.
- Patients with the lot are told to stop using the product and contact their health care provider for guidance rather than stopping therapy on their own; Vitruvias says it has received no known adverse-event reports to date and the company has ceased operations and transferred products to H2‑Pharma while wholesalers are to halt distribution and destroy remaining inventory.