The recalled tablets from Vitruvias Therapeutics, Inc. are “superpotent,” the company said, meaning they are stronger than expected

Stock photo of pills spilling out of bottle.Credit: Getty
Stock photo of pills spilling out of bottle.
Credit: Getty

NEED TO KNOW

  • The FDA has elevated the recall of a thyroid medication to Class I, due to potential serious health risks
  • The recalled tablets from Vitruvias Therapeutics, Inc. are “superpotent,” which could lead to hyperthyroidism and complications in vulnerable groups like pregnant people and infants
  • Consumers have been advised to consult their healthcare provider before stopping or switching the recalled medication

A recall for thyroid medication that was first initiated in August has been elevated to the FDA’s highest warning level.

On Tuesday, Sept. 22, the FDA designated a voluntary recall from Vitruvias Therapeutics, Inc. as Class I — meaning there could potentially be “adverse health consequences or death” for anyone who uses the medication.

Vitruvias said in a press release during its initial recall in August that one lot of its thyroid tablets, USP 30 mg, was “superpotent,” and could be more concentrated than intended.

The medication is used to treat hypothyroidism, or an underactive thyroid, and use of the potentially superpotent drug could cause hyperthyroidism, or an overactive thyroid, according to the pharmaceutical company.

“To date, Vitruvias Therapeutics has not received any reports of adverse events known to be related to this recall,” the company said. (Stock)Credit: Getty
“To date, Vitruvias Therapeutics has not received any reports of adverse events known to be related to this recall,” the company said. (Stock)
Credit: Getty

According to Vitruvias, hyperthyroidism can have other side effects, including weight loss, heat intolerance, fatigue, nervousness, muscle weakness and heart rhythm disturbances. Those most commonly affected include the elderly, pregnant women, and infants — “especially over extended periods of time.”

Excess levels of thyroid hormones have been known to cause cardiac health issues and have been associated with maternal and fetal complications, as well as potentially negative effects on growth and development in babies.

“To date, Vitruvias Therapeutics has not received any reports of adverse events known to be related to this recall,” the company added in August.

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The affected lot number is 504950 with a label reading “Thyroid Tablets, USP.” The recalled tablets were distributed from Jan. 31 to Sept. 30, 2025, and expire on Sept. 30, 2026.

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

Anyone who has identified the recalled tablets should not stop taking them or switch to another medication without contacting their health care provider for guidance, the FDA said.

“Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product,” the company added.

Anyone with questions about the recall can contact Vitruvias Therapeutics, Inc. via email at safety@vitruvias.com or by phone at (256) 239-9373.

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