Vitruvias Therapeutics Issues Nationwide Recall for Thyroid Medication Due to Superpotency Concerns
Auburn, Alabama-based pharmaceutical company Vitruvias Therapeutics has initiated a voluntary, nationwide recall of a specific lot of its thyroid medication after testing revealed the tablets could be “superpotent,” potentially leading to serious health complications for users.
The recall, which was formally published by the U.S. Food and Drug Administration (FDA) this week, targets Lot 504950 of Thyroid Tablets, USP 30 mg. According to the company, the affected batch was found to contain higher levels of the active hormone than intended, which can trigger hyperthyroidism, or an overactive thyroid.
Potential Health Risks
The medication, derived from porcine thyroid glands, contains a combination of levothyroxine and liothyronine and is primarily prescribed to treat hypothyroidism (an underactive thyroid). Because the recalled tablets are more potent than the labeled dosage, patients may inadvertently suffer from an overdose of thyroid hormones.
The company warned that individuals experiencing this unintended potency may notice symptoms such as rapid heart rate, heart rhythm disturbances, high blood pressure, nervousness, fatigue, heat intolerance, muscle weakness, and unexplained weight loss.
The medical risks are particularly elevated for vulnerable populations. The company noted that elderly patients are at an increased risk of cardiac complications, while pregnant women face a higher risk of premature delivery and low birth weight infants. Additionally, infants exposed to excessive thyroid hormone levels may experience long-term negative effects on their growth and development.
Recall Scope and Guidance
The recall encompasses 3,655 units of the medication, of which approximately 1,955 units were sold. The affected product carries NDC 69680-166-00 and bears an expiration date of Sept. 30, 2026. These units were distributed to direct accounts nationwide between Jan. 31, 2025, and Sept. 30, 2025.
While Vitruvias Therapeutics has confirmed that no reports of adverse events related to the recall have been received to date, the company is urging immediate caution.
“Patients currently taking tablets from the affected lot should not stop taking the medication without first contacting their healthcare provider for guidance or a replacement prescription,” the company stated in its official notice.
Wholesalers have been instructed to stop all distribution of the affected lot and are currently working with the company to arrange for the destruction of the product.
What Consumers Should Do
Patients who believe they have been affected or who are currently in possession of the recalled medication should:
- Contact their physician or healthcare provider to discuss alternative treatment options.
- Reach out to Vitruvias Therapeutics directly for further information via email at safety@vitruvias.com or by calling 256-239-9373.
- Report any adverse reactions or quality problems associated with this thyroid medication to the FDA’s MedWatch Adverse Event Reporting program.
The recall is being conducted with full oversight from the FDA, and consumers are encouraged to monitor future updates regarding the safe disposal of the tablets.
