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

The US Food and Drug Administration (FDA) has elevated the recall status of Vitruvias Therapeutics' thyroid tablets due to potential "superpotent" thyroid hormone levels that could lead to serious health complications. Classified as a Class I recall, this indicates the product could cause severe health consequences or even death.

The recall pertains to a specific lot (504950, NDC 69680-166-00) of Thyroid Tablets USP 30 mg, with an expiration date of September 30, 2026. Though around 3,655 units were distributed, around 1,955 were actually sold.

The recall was prompted by concerns that the affected tablets may contain excessive thyroid hormone levels, potentially leading to overactive thyroid conditions. Symptoms may include weight loss, heat intolerance, fatigue, high blood pressure, chest pain, rapid heart rate, and irregular heart rhythms. The FDA emphasizes that the risk is heightened in vulnerable populations, especially elderly patients, pregnant women, and infants.

These groups may face more severe consequences due to extended exposure to excessive thyroid hormones.

For those currently taking the recalled tablets, the FDA advises continuing the medication until consulting with a healthcare professional, who can provide guidance on next steps or arrange for a replacement prescription. Vitruvias Therapeutics encourages patients with questions to contact them at safety@vitruvias.com or (256) 239-9373. The company, which announced it had ceased operations, has transferred all remaining products to H2-Pharma LLC.