Thyroid Tablets Recalled Due to Drug Superpotency

Key Takeaways:

• The US Food and Drug Administration (FDA) has issued a voluntary Class I recall for thyroid tablets, USP, 30 mg. The affected batch has been identified as Lot 504950 (expires September 2026), containing 1955 bottles.
• The recall was initiated by Vitruvias Therapeutics, Inc due to drug superpotency, a quality issue that is likely to cause serious adverse health consequences or death.
• Thyroid tablets are used to treat hypothyroidism, goiters, and thyroid cancer.

The FDA has issued a Class I recall for thyroid tablets, USP, 30 mg, affecting 1955 bottles. This product is being recalled by Vitruvias Therapeutics, Inc based in Auburn, Alabama. The recall was initiated on August 21, 2026, and received a Class I classification on September 22, 2026. A Class I classification means the use of this product is likely to cause serious adverse health consequences or death.

The recall was initiated due to the presence of a superpotent drug. The affected product is Lot 504950, which will expire in September 2026. Vitruvias Therapeutics sent out a public notice via letter; a press release was issued on August 21, 2026.

Thyroid tablets are used to treat hypothyroidism and thyroid cancer. They can also be used to decrease the size of goiters. Pharmacists should identify and quarantine Lot 504950, remove it from inventory, and coordinate with prescribers to provide an alternative supply.

Reference

FDA. Enforcement Report. September 23, 2026. Accessed September 24, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=222257