The U.S. Food and Drug Administration has upgraded a recall of Vitruvias Therapeutics’ 30mg thyroid tablets to a class I designation.
This marks the agency’s highest-risk category warning that the medication can lead to severe health consequences or even death.
The recall, initiated voluntarily last month, applies to one lot of “Thyroid tablets, USP” identified by lot number 504950 and National Drug Code 69680-166-00. The tablets have an expiration date of September 30, 2026, and were distributed nationwide between January 31 and September 30, 2025. Around 1,955 of 3,655 units were sold.
Further testing confirmed that the tablets could be “superpotent”, implying that they are stronger than intended. According to the FDA, consuming superpotent thyroid medication can trigger an overactive thyroid, leading to weight loss, heat intolerance, fatigue, hypertension, chest pain, rapid heart rate, and heart rhythm disturbances.
Elderly patients, pregnant women, and infants face the greatest risk, especially with prolonged use.
Class I recalls suggest a reasonable probability that exposure to the product will cause serious adverse health effects or death. Vitruvias Therapeutics said it had received no reports of adverse events tied to the lot as of the recall notice’s August 24 publication.
The company recently announced it has ceased operations, with its products now owned or distributed by H2-Pharma LLC.
