Vitruvias therapeutics thyroid recall fda

On 22 September 2026, the U.S. Food and Drug Administration (FDA) announced a formal recall of specific lots of Levothyroxine Sodium tablets manufactured by Vitruvias Therapeutics. The recall was initiated following internal quality control testing that identified potential sub-potency issues within certain batches of the medication. Levothyroxine is a critical hormone replacement therapy used to treat hypothyroidism, and the FDA warned that tablets failing to meet potency specifications could lead to inadequate treatment of thyroid conditions, potentially resulting in serious health complications for patients relying on consistent dosing. Vitruvias Therapeutics has begun notifying distributors and pharmacies to immediately quarantine and return the affected products. The company is working closely with federal regulators to investigate the root cause of the manufacturing discrepancy. Patients currently prescribed this medication are advised to check their prescription labels against the lot numbers listed on the FDA’s official recall database. Healthcare providers have been instructed to contact affected patients to arrange for alternative supplies of the medication. No adverse events related to this specific recall have been reported to the agency as of the publication date.