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FDA Issues High-Risk Warning on Thyroid Drug
25 Sep
Summary
- Thyroid medication recalled for being too potent.
- FDA designated recall as Class 1 risk level.
- Nearly 2,000 units of recalled medication sold.
A thyroid medication, initially recalled in August due to excessive potency, has been issued a Class 1 risk warning by the U.S. Food and Drug Administration. This designation signifies a high probability of serious adverse health consequences or even death.
The recalled 30-mg tablets, branded as Vitruvius Therapeutics, were distributed nationwide from January 31 to September 30, 2025. They are used to treat hypothyroidism but were found to be too potent, increasing the risk of hyperthyroidism.
Vitruvias Therapeutics has since ceased operations and transferred its products to H2-Pharma. The FDA reported that nearly 2,000 of the 3,655 units released from the affected lot were sold. Consumers are advised to contact their healthcare provider before discontinuing treatment.
