FDA Elevates Vitruvias Thyroid Tablet Recall to Class I Over Superpotency Risk
核心洞察
The FDA upgraded Vitruvias Therapeutics' voluntary recall of one lot of Thyroid Tablets, USP 30 mg (搜索) to Class I, its highest risk designation, on Tuesday.
Testing confirmed the potential for the product to be superpotent, which can cause hyperthyroidism (搜索) and related cardiovascular and metabolic effects in patients.
About 3,655 units of lot 504950 were distributed nationwide to the company's direct accounts between Jan. 31 and Sept. 30, 2025, expiring Sept. 30, 2026.
The U.S. Food and Drug Administration has upgraded a recall of Vitruvias Therapeutics' thyroid medication to Class I, the agency's highest risk level, after testing confirmed the product has the potential to be superpotent.
Vitruvias Therapeutics Inc. (搜索) voluntarily recalled one lot of its Thyroid Tablets, USP 30 mg (搜索) in late August. On Tuesday, the FDA reclassified the action as Class I, defined as "a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death."
Product and Distribution Details
The recalled lot number is 504950. Approximately 3,655 units were distributed nationwide to Vitruvias Therapeutics' direct accounts between Jan. 31, 2025 and Sept. 30, 2025. The expiration date for the affected tablets is Sept. 30, 2026.
Thyroid, USP is indicated for the treatment of hypothyroidism (搜索), or an underactive thyroid, according to the FDA.
Clinical Risks of Overpotent Tablets
According to the company, consumption of superpotent thyroid tablets can cause hyperthyroidism (搜索), or overactive thyroid (搜索), and related negative health effects. Symptoms associated with an overactive thyroid include weight loss, heat intolerance, fatigue, nervousness, muscle weakness, hypertension, chest pain, rapid heart rate and heart rhythm disturbances.
The FDA states that elderly people, pregnant women and infants are at greater risk of harm from an overactive thyroid (搜索). The company similarly identifies older adults, pregnant women and infants as most at risk of adverse effects from over-treating hypothyroidism (搜索).
Adverse Event Status and Guidance for Patients
As of Aug. 24, there had been no reports of injuries or deaths linked to the recalled tablets. The company said in August that it had not received any reports of adverse events known to be related to the recall.
Vitruvias advised that patients currently taking the recalled tablets should not stop taking them without contacting their healthcare provider for further guidance or a replacement prescription. Patients who experience adverse health effects after taking the medication should contact their healthcare provider and report the event to the FDA's MedWatch Adverse Event Reporting program.
Vitruvias said it is reaching out to wholesalers to ensure the recalled tablets are destroyed.