FDA upgrades Vitruvias Therapeutics recall: Superpotent thyroid tablets could trigger heart problems; who is at risk?

The FDA has classified Vitruvias Therapeutics' recall of thyroid tablets as Class I due to potential superpotency, posing a risk of serious health issues. The affected lot includes approximately 3,655 units. 

The US Food and Drug Administration (FDA) has raised the risk classification of a recall involving Vitruvias Therapeutics’ thyroid tablets after testing found that the medicine could be “superpotent”, meaning it may contain more thyroid hormone than intended.

AS per the FDA, a Class I recall means that using the product could reasonably be expected to cause serious adverse health consequences or death.

The recall covers one specific lot of Vitruvias Therapeutics’ Thyroid Tablets, USP 30 mg.

The affected product is identified by lot number 504950 and National Drug Code number 69680-166-00, with an expiration date of 30 September 2026. Of approximately 3,655 units distributed, roughly 1,955 were sold. The tablets were distributed nationwide between 31 January and 30 September 2025.

The concern stems from the possibility that tablets in the affected batch could deliver excessive levels of thyroid hormone. Thyroid, USP is a natural preparation derived from porcine thyroid glands and contains levothyroxine and liothyronine. It is prescribed to treat hypothyroidism, or an underactive thyroid.

What are the health issues associated with the drug?

According to the FDA recall notice, taking superpotent thyroid tablets puts patients at risk of developing an overactive thyroid, which can manifest as weight loss, heat intolerance, fatigue, hypertension, chest pain, rapid heart rate, and heart rhythm disturbances.

Who are most at risk?

The FDA specifically identifies that elderly patients, pregnant women, and infants face the greatest risks, particularly over extended periods.

• Excess levels of thyroid hormones in the elderly have been associated with adverse outcomes, particularly to cardiac health.
• Overtreatment of hypothyroidism in pregnancy is associated with a higher rate of maternal and fetal complications, including premature delivery and low birth weight.
• Overtreatment of hypothyroidism in infants may have negative effects on growth and development

What to do if you already have the batch?

The FDA cautioned that patients taking tablets from this lot should continue taking them until they speak with a healthcare provider, who can advise on next steps or issue a replacement prescription. Questions can be directed to Vitruvias Therapeutics at safety@vitruvias.com or (256) 239-9373.

What did the company say?

Vitruvias Therapeutics said it had not received reports of adverse events known to be connected to the recall when the original recall notice was issued in August.

Vitruvias Therapeutics previously notified wholesalers to stop distributing the recalled product and to arrange for its destruction. Nearly 2,000 bottles had been issued, as per News Nation.

The company recently announced online it had “ceased operations,” with all products now owned and/or distributed by H2-Pharma LLC.

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