Thyroid medicine recall receives FDA's highest risk level

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 Therapeutics Inc. recalled one lot of its 30 mg thyroid tablets because they could be superpotent, or stronger than intended, according to a FDA recall notice published on Aug. 24.

The affected products include thousands of units distributed nationwide from January to September 2025 with an expiration date in September 2026, according to the notice.

A Class I recall – the most serious FDA category – indicates that using the product is likely to cause serious health effects or death, according to the agency.

Which thyroid medicine was recalled?

One lot of Vitruvias Therapeutics' 30 mg thyroid tablets was recalled.

The affected products are labeled "Thyroid Tablets, USP" and have an expiration date of Sept. 30, 2026. They were distributed nationwide between Jan. 31-Sept. 30, 2025.

About 1,900 units were sold from a batch of about 3,600, according to the notice.

They can be identified by the National Drug Code number 69680-166-00 or lot number 504950.

Why was thyroid medicine recalled?

The thyroid tablets were recalled because testing confirmed they could potentially be superpotent, or stronger than intended.

Consuming superpotent thyroid tablets can cause an overactive thyroid and issues like weight loss, heat intolerance, fatigue and hypertension, according to the notice.

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

What to do if you have recalled thyroid tablets

Anyone who is currently taking the recalled tablets should not stop without contacting their health care provider for further guidance, according to the FDA notice.

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

Melina Khan is a national trending reporter for USA TODAY. Keep up with her on X @melinakh and Instagram @bymelinakhan.