FDA Upgrades Vitruvias Therapeutics Recall: Superpotent Thyroid Pills May Cause Heart Problems; who is at risk?

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

According to the FDA, a Class I recall means that use of the product can reasonably be expected to cause serious adverse health consequences or death.

The recall concerns 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 September 30, 2026. Of the approximately 3,655 units distributed, approximately 1,955 have been sold. The tablets were distributed nationwide from January 31 to September 30, 2025.

The concern stems from the possibility that the tablets in the affected lot may be delivering excessive levels of thyroid hormone. Thyroid Gland, USP is a natural preparation obtained from porcine thyroid glands and contains levothyroxine and liothyronine. It is prescribed to treat hypothyroidism or an underactive thyroid gland.

What are the health problems associated with the drug?

According to the FDA’s recall notice, Super Potency Thyroid Tablets put patients at risk of developing an overactive thyroid gland, which can manifest as weight loss, heat intolerance, fatigue, hypertension, chest pain, fast heartbeat, and heart rhythm disturbances.

Who is most at risk?

The FDA specifically states that elderly patients, pregnant women, and infants face the greatest risks, especially over a longer period of time.

Excessive levels of thyroid hormones in the elderly have been linked to adverse consequences, particularly for heart health.
Overtreatment of hypothyroidism in pregnancy is associated with higher rates of maternal and fetal complications, including preterm birth and low birth weight.
Overtreatment of hypothyroidism in infants can have negative effects on growth and development

What to do if you already have a dose?

The FDA warned that patients taking tablets from this batch should continue taking them until they speak with a healthcare provider who can advise them on what to do next or issue a replacement prescription. Questions may 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 related to the recall when the original recall notice was issued in August.

Vitruvias Therapeutics previously notified wholesalers to stop distribution of the recalled product and ensure its destruction. According to News Nation, nearly 2,000 bottles were released.

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