FDA Raises Thyroid Tablet Recall to Most Serious Level Over Superpotency Issue

The Food and Drug Administration this week elevated a prescription thyroid medication recall to its most serious classification because the medication is too potent.

Several weeks ago, Vitruvias Therapeutics said in a notice published by the FDA that it was voluntarily recalling one lot of thyroid tablets because the medication is “superpotent” and can “cause hyperthyroidism,” or an overactive thyroid, in some people.

The affected lot, 504950, was distributed across the United States by Alabama-based Vitruvias Therapeutics between Jan. 31, 2025. and Sept. 30, 2025. The drug’s expiration date is Sept. 30, 2026, according to the FDA notice.

In an enforcement report updated on Sept. 22, the FDA classified the thyroid tablets as a Class I recall, the most severe in its three-tiered system.

According to the FDA’s website, a Class I recall is a situation where there is a “reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”

A statement released by Vitruvias Therapeutics in August warned that consumption of the “superpotent” thyroid medication can cause hyperthyroidism that can include symptoms such as “weight loss, heat intolerance, fatigue, nervousness, muscle weakness, hypertension, chest pain, rapid heart rate, or heart rhythm disturbance.”

Those who are considered at a greater risk of developing adverse reactions include pregnant women, infants, and elderly people, according to the notice. For the elderly, high levels of thyroid hormones have been linked to adverse events, including cardiac health-related problems, it said.

In infants, an overtreatment can also have “negative effects on growth and development,” the company said.

But as of the issuance of the Aug. 21 news release, the company has not received any reports of adverse health events linked to the recalled tablets, it said.

The medication is described by the company as “a natural preparation derived from porcine thyroid glands composed of levothyroxine and liothyronine” and used to treat an underactive thyroid, or hypothyroidism.

In the release, Vitruvias Therapeutics advised patients not to stop using the medication without first contacting their healthcare provider for guidance or a replacement prescription. That was before the FDA classified the recall as its most serious.

The company said it would notify retailers to discontinue the distribution of the recalled medication and would arrange for the “destruction” of all the tablets under recall.

Those with concerns or questions can contact the company or the FDA through the information listed in the agency’s press release.

Vitruvias Therapeutics did not respond to a request for comment by publication time.

Over the summer, at least two other thyroid medications were recalled in separate instances by different companies.

Major Pharmaceuticals, an Ohio-based company, issued a recall of levothyroxine sodium on July 13. The FDA labeled the action as a Class II recall on July 17.

In August, levothyroxine sodium tablets in different strengths, contained in bottles of different counts, were recalled. They were manufactured by India-based Intas Pharmaceuticals Limited for North Carolina-based Accord Healthcare Inc. and distributed across the United States.