Nationwide Recall of Thyroid Medication
Vitruvias Therapeutics is voluntarily recalling one lot of thyroid medication distributed nationwide after testing found the tablets could be more potent than intended. The recall, announced by the U.S. Food and Drug Administration (FDA) on Monday, affects Lot 504950 of Thyroid Tablets, USP 30 mg, at the consumer level.
The Auburn, Alabama-based company initiated the recall because of the potential for the medication to be "superpotent." According to the company, taking superpotent thyroid tablets can cause hyperthyroidism, or an overactive thyroid, with symptoms that may include weight loss, heat intolerance, fatigue, nervousness, muscle weakness, high blood pressure, chest pain, rapid heart rate, and heart rhythm disturbances.
Risks to Vulnerable Populations
The company highlighted that elderly patients, pregnant women, and infants face greater risks from excessive thyroid hormone levels, particularly with extended use. Excess thyroid hormone has been associated with cardiac problems in elderly patients, while overtreatment during pregnancy has been linked to premature delivery and low birth weight. In infants, overtreatment may negatively affect growth and development.
Vitruvias Therapeutics said it has not received any reports of adverse events known to be connected to the recall. The company is notifying wholesalers to stop distributing the recalled product and is arranging for its destruction.
Product Details and Distribution
The recalled product carries NDC 69680-166-00 and an expiration date of Sept. 30, 2026. The company released 3,655 units and reported that 1,955 units were sold. The affected lot was distributed nationwide to the company's direct accounts between Jan. 31, 2025, and Sept. 30, 2025.
Thyroid, USP is derived from porcine thyroid glands and contains levothyroxine and liothyronine. The medication is used to treat hypothyroidism, or an underactive thyroid.
Consumer Guidance
Patients currently taking tablets from the affected lot are advised not to stop taking the medication without first contacting their healthcare provider. Consumers with questions can contact Vitruvias Therapeutics at safety@vitruvias.com or at 256-239-9373. Anyone who has experienced problems that may be connected to the medication should contact a physician or healthcare provider.
The recall is being conducted with the knowledge of the FDA. A representative for Vitruvias Therapeutics did not immediately respond to FOX Business' request for additional information.