- The FDA has classified the recall as Class I.
- The affected tablets could be more potent than intended.
- Vitruvias Therapeutics has ceased operations.
The US Food and Drug Administration has upgraded the recall of a thyroid medicine to its most serious category, weeks after the manufacturer warned that one batch of the tablets could be stronger than intended.
The recall involves one lot of Thyroid Tablets, USP 30mg, made by Vitruvias Therapeutics. The affected lot, numbered 504950, was recalled in August after testing confirmed the potential for the tablets to be “superpotent”.
The FDA classified the recall as Class I on September 22. The category is used when there is a reasonable probability that exposure to a recalled product could cause serious adverse health consequences or death.
The affected tablets were distributed nationwide in the US between January 31 and September 30, 2025. They carry an expiration date of September 30, 2026.
According to the FDA, 3,655 units were released and 1,955 were sold. The company had instructed wholesalers to stop distributing the affected product and arrange for its destruction.
Why the tablets were recalled
Thyroid Tablets, USP is used to treat hypothyroidism, or an underactive thyroid. The product is a natural preparation derived from porcine thyroid glands and contains the thyroid hormones levothyroxine and liothyronine.
If the tablets contain more thyroid hormone than intended, they can cause hyperthyroidism, or an overactive thyroid.
The FDA says potential effects can include weight loss, heat intolerance, fatigue, nervousness, muscle weakness, high blood pressure, chest pain, rapid heartbeat and heart rhythm disturbances.
Elderly people, pregnant women and infants can face greater risks, particularly with prolonged exposure. The agency notes that excess thyroid hormone in older people has been associated with adverse cardiac outcomes, while overtreatment during pregnancy can increase the risk of complications.
However, Vitruvias said when the recall was announced that it had not received any reports of adverse events known to be related to the recall.
The recall has also coincided with a change in the status of the company behind the product.
Vitruvias Therapeutics has announced that it has ceased operations, with its products now owned and/or distributed by H2-Pharma, according to reports following the company's announcement.
For anyone who may have the recalled lot, the FDA advises patients not to stop taking the medicine without first contacting their healthcare provider for guidance or a replacement prescription. Patients who believe they have experienced a problem related to the medicine should also contact their healthcare provider.
