Vitruvias Therapeutics Thyroid Tablet Recall: 'Superpotent' Pills Risk Elderly and Pregnant Patients

A batch of prescription thyroid tablets is being recalled across the United States after testing found the pills could be stronger than the label states, posing the greatest risk to older adults and pregnant women.

Vitruvias Therapeutics Inc., based in Auburn, Alabama, is voluntarily recalling a single lot of its Thyroid Tablets, USP 30 mg to the consumer level. The company said testing confirmed the batch had the potential to be 'superpotent', meaning each tablet may carry more active hormone than intended.

The recall extends to the consumer level, the tier that covers medicine already in patients' hands rather than stock held in warehouses. The affected batch is Lot 504950, which carries National Drug Code 69680-166-00 and an expiration date of 30 September 2026. Of the 3,655 units released, 1,955 were sold before the problem was identified. The tablets were distributed nationwide to the company's direct accounts between 31 January 2025 and 30 September 2025.

Thyroid, USP is a natural medicine made from porcine thyroid glands and contains the hormones levothyroxine and liothyronine. Doctors prescribe it for hypothyroidism, an underactive thyroid that leaves the body short of the hormones it needs to regulate energy, weight, and heart rate.

Why Elderly and Pregnant Patients Face the Greatest Risk

A tablet that delivers too much hormone can have the opposite of its intended effect. Instead of treating an underactive thyroid, it can push a patient into hyperthyroidism, or an overactive thyroid, Vitruvias said. The company named the elderly, pregnant women, and infants as the groups most exposed, especially when the pills are taken over an extended period.

In older patients, an excess of thyroid hormone has been linked to adverse outcomes, chiefly involving the heart. During pregnancy, overtreatment is associated with a higher rate of maternal and fetal complications, among them premature delivery and low birth weight. In infants, too much hormone can affect normal growth and development.

Signs that a dose is running too high include weight loss, heat intolerance, fatigue, nervousness, muscle weakness, high blood pressure, chest pain, rapid heart rate, and heart rhythm disturbances. Vitruvias said it had received no reports of adverse events connected to the recall by the time the notice was issued.

What Patients Taking the Recalled Lot Should Do

The company urged anyone using tablets from Lot 504950 not to stop on their own. Halting thyroid medication without advice can be dangerous, so patients are told to contact their doctor or healthcare provider first for guidance or a replacement prescription.

Patients can confirm whether their medicine is affected by matching the lot number, 504950, or the NDC, 69680-166-00, printed on the label. Vitruvias is notifying wholesalers by email and phone to stop distribution and is arranging for the remaining stock to be destroyed.

Anyone with questions can reach the company at [email protected] or on (256) 239-9373, Monday to Friday from 9 a.m. to 5 p.m. CT. Suspected reactions can also be reported to the FDA through its MedWatch programme.

A Second Thyroid Recall in a Matter of Weeks

The announcement follows a separate thyroid recall weeks earlier.

In July 2026, Major Pharmaceuticals recalled levothyroxine sodium tablets after the FDA found them subpotent, meaning they held less active ingredient than the label claimed.

That recall involved the opposite problem, with patients at risk of receiving too little hormone rather than too much.

The FDA classified the Major Pharmaceuticals recall as Class II, a category for products that may cause temporary or reversible health effects. Thyroid recalls have recurred over the past year, including subpotent levothyroxine batches withdrawn by Accord Healthcare.

The Vitruvias recall is being carried out with the knowledge of the FDA.