Overview
- Vitruvias voluntarily recalled one lot (Lot 504950, NDC 69680-166-00) of Thyroid Tablets, USP 30 mg after internal testing found the tablets could be superpotent.
- The FDA upgraded the recall to its highest-risk Class I on Sept. 22, indicating a reasonable probability that exposure could cause serious adverse health consequences or death.
- About 3,655 units from the lot were released to distribution between Jan. 31 and Sept. 30, 2025, and roughly 1,955 bottles were sold nationwide before the recall.
- Regulators and the company advise patients not to stop therapy without consulting their clinician and to seek immediate care for symptoms such as rapid heartbeat, chest pain, sudden weight loss, or other signs of overactive thyroid.
- Vitruvias says it has received no reports of adverse events tied to this lot and has ceased operations while transferring products to H2-Pharma; wholesalers were ordered to stop distribution and arrange destruction of remaining inventory.