Vitruvias Therapeutics is voluntarily recalling one lot of Thyroid Tablets, USP 30 mg nationwide after laboratory testing indicated the medication may be more potent than intended. The U.S. Food and Drug Administration (FDA) published the company's recall notice on Monday.
Lot 504950 of the thyroid medication is being recalled at the consumer level. The affected product, distributed between January 31, 2025, and September 30, 2025, carries the NDC number 69680-166-00 and an expiration date of September 30, 2026. Vitruvias Therapeutics reported releasing 3,655 units of this lot and selling 1,955 units.
Potential Health Risks
Taking thyroid medication that is more potent than prescribed can lead to hyperthyroidism, a condition characterized by an overactive thyroid. Symptoms associated with hyperthyroidism include weight loss, heat intolerance, fatigue, nervousness, muscle weakness, elevated blood pressure, chest pain, rapid heart rate, and heart rhythm disturbances. The company stated that elderly patients, pregnant women, and infants are at a higher risk for adverse effects from excessive thyroid hormone levels, particularly with prolonged use. Excessive thyroid hormone has been linked to cardiac issues in older adults, while overtreatment during pregnancy can result in premature delivery and low birth weight. In infants, it may negatively impact growth and development.
Vitruvias Therapeutics has stated that it has not received any reports of adverse events connected to the recalled medication. The recall is being conducted with the FDA's knowledge.
Medication Details and Next Steps
Thyroid, USP is a medication derived from porcine thyroid glands that contains both levothyroxine and liothyronine. It is prescribed to treat hypothyroidism, or an underactive thyroid. The recalled medication is manufactured by Auburn, Alabama-based Vitruvias Therapeutics.
The company is informing its wholesalers to stop distributing the recalled product and is arranging for its destruction. Patients currently taking medication from the recalled lot are advised not to discontinue their treatment without consulting their healthcare provider for guidance or a new prescription.
Consumers with questions regarding the recall can contact Vitruvias Therapeutics by email at [email protected] or by phone at 256-239-9373. Individuals who have experienced problems they suspect may be related to the medication should consult a physician or healthcare provider.