A thyroid medicine is being recalled at the FDA’s highest risk level, causing confusion among Americans who use medication to manage thyroid conditions.
The recall applies to one lot of 30-milligram thyroid tablets sold by Vitruvias Therapeutics. About 1,900 units from a batch of roughly 3,600 were sold nationwide. The tablets have an expiration date of Sept. 30, 2026, and were distributed between Jan. 31 and Sept. 30, 2025.
Check the packaging for National Drug Code number 69680-166-00 or lot number 504950. The tablets are off-white to pale brown, round and may have flecks. One side is marked “THY” and the other “050.”
The company said the recalled product is not Levothyroxine or Synthroid, which are dosed in micrograms. That distinction may help explain some of the confusion. Levothyroxine is one of the most commonly prescribed drugs in the United States, with about 7% of the population estimated to have an active prescription, according to a 2023 Mayo Clinic post.
Why the FDA Classified the Recall as Class I
The FDA categorized the recall as Class I, its highest risk level, on Sept. 22. The agency says a Class I recall means using the product could cause serious health effects or death.
The recall was issued because the tablets could be superpotent, or stronger than intended, according to the original FDA recall notice published Aug. 24. Taking superpotent thyroid tablets can cause an overactive thyroid and symptoms including weight loss, heat intolerance, fatigue and hypertension.
What to Do If You Have the Recalled Tablets
If you are taking the recalled tablets, contact your health care provider for guidance, according to the FDA notice. Consumers with questions can contact Vitruvias Therapeutics at [email protected] or 256-239-9373.
This article is for informational purposes and is not a substitute for medical advice. Contact a qualified health care professional with questions about your medication.
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