Thyroid Medicine Recall Receives FDA’s Highest Risk Level

USA TODAY Network / Reuters

Officials have classified the risk level of a thyroid medicine recall initiated last month to its most serious category.

On Sept. 22, the U.S. Food and Drug Administration categorized the recall, which applies to one lot of thyroid tablets sold by Vitruvias Therapeutics Inc., as a Class I recall, its highest risk level.

Last month, Vitruvias recalled one lot of its 30 mg thyroid tablets because they could be superpotent, or stronger than intended, according to an FDA recall notice published Aug. 24.

The affected products were distributed nationwide from Jan. 31 through Sept. 30, 2025, and have an expiration date of Sept. 30, 2026. About 1,900 units were sold from a batch of about 3,600, according to the notice.

Which Thyroid Medicine Was Recalled?

One lot of Vitruvias Therapeutics’ 30 mg thyroid tablets was recalled. The affected products are labeled “Thyroid Tablets, USP.”

Check the package for these identifying details:

  • National Drug Code: 69680-166-00
  • Lot number: 504950
  • Expiration date: Sept. 30, 2026

The products were distributed nationwide, so consumers in any state may have received the recalled lot.

Why Was the Thyroid Medicine Recalled?

Testing confirmed the tablets could potentially be superpotent, meaning they may contain more thyroid medicine than intended.

Taking superpotent thyroid tablets can cause an overactive thyroid and symptoms such as weight loss, heat intolerance, fatigue and hypertension, according to the FDA notice.

Vitruvias said it had not received reports of adverse events tied to the recall as of the notice’s publication on Aug. 24.

What to Do If You Have the Recalled Tablets

If you are taking the recalled tablets, do not stop taking them without contacting your health care provider for guidance, according to the FDA. A medical professional can tell you how to handle your medication safely.

Consumers with questions can contact Vitruvias Therapeutics at [email protected] or 256-239-9373.

 

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