Overview
- Vitruvias Therapeutics voluntarily recalled one lot of Thyroid Tablets, USP after internal tests found the tablets delivered more thyroid hormones than labeled.
- The FDA upgraded the recall to Class I on Sept. 22, signaling a reasonable probability of serious adverse health consequences or death and heightening removal and monitoring efforts.
- The recall covers NDC 69680-166-00, Lot 504950 — 1/2 Grain (30 mg) 100-count bottles expiring Sept. 30, 2026 — with 3,655 units released from Jan. 31–Sept. 30, 2025 and about 1,955 bottles sold nationwide.
- Patients who have the product should stop using it only after consulting their clinician, because excess T4/T3 can cause overactive thyroid and serious heart problems for older adults, pregnant people, infants and those with cardiac disease.
- Vitruvias says it has ceased operations and transferred products to H2-Pharma; regulators are tracking complaints and ask consumers and clinicians to report adverse events through FDA MedWatch as pharmacies and wholesalers locate affected bottles.