AUBURN, Ala. — A thyroid medication distributed across the United States is being recalled after testing found that one lot could be more potent than intended, raising concerns about patients receiving excessive levels of thyroid hormone.
Vitruvias Therapeutics announced a voluntary recall of Thyroid Tablets, USP 30 mg, Lot 504950 at the consumer level. The U.S. Food and Drug Administration published the company’s recall announcement on Aug. 24, 2026.
The company said testing confirmed the potential for the tablets to be “superpotent.”
The affected medication is used to treat hypothyroidism, a condition in which the body does not produce enough thyroid hormone. Thyroid, USP is a natural preparation derived from porcine thyroid glands and contains levothyroxine and liothyronine.
Recalled Lot and Product Details
The FDA-listed recall involves a specific lot rather than every Thyroid Tablets, USP 30 mg product.
Patients can check their medication against the following identifying information:
- Product: Thyroid Tablets, USP 30 mg
- Lot: 504950
- NDC: 69680-166-00
- Expiration date: Sept. 30, 2026
- Units released: 3,655
- Units sold: 1,955
According to the FDA, the affected lot was distributed nationwide through Vitruvias Therapeutics’ direct accounts between Jan. 31, 2025, and Sept. 30, 2025.
Vitruvias said it is notifying wholesalers and asking them to stop distributing the recalled product. The company is also arranging for recalled tablets to be destroyed.
What Can Happen If Thyroid Tablets Are Too Strong?
Taking thyroid medication that contains more hormone than intended can result in hyperthyroidism, or an overactive thyroid.
According to the company’s FDA-posted recall notice, possible symptoms can include weight loss, heat intolerance, fatigue, nervousness, muscle weakness, high blood pressure, chest pain, rapid heart rate and heart rhythm disturbances.
Certain groups face greater risks from excessive thyroid hormone, particularly with prolonged exposure. The company specifically identified elderly patients, pregnant women and infants as populations at greater risk.
Excess thyroid hormone can be associated with cardiac problems in older patients, while overtreatment during pregnancy has been linked with complications including premature delivery and low birth weight. In infants, excessive treatment may negatively affect growth and development.
Despite the potential safety concern, Vitruvias said it has not received reports of adverse events known to be connected to this recall.
FDA Has Raised Broader Concerns About Animal-Derived Thyroid Drugs
The recall comes as the FDA has also been raising concerns about unapproved animal-derived thyroid medications, including potential problems involving quality, potency and dosing.
The agency says tablets made from animal-derived thyroid material may not always provide consistent thyroid hormone levels. According to the FDA, too much medication can cause unwanted effects, while too little may fail to adequately treat hypothyroidism.
The FDA has recommended that patients taking unapproved animal-derived thyroid medications for hypothyroidism talk with their doctor about their treatment.
Patients Should Not Stop Medication Without Medical Guidance
Anyone who believes they may have the recalled lot should first check the lot number and product information on their medication.
Vitruvias specifically advises patients currently taking Thyroid, USP from Lot 504950 not to discontinue treatment without first contacting their healthcare provider. A doctor can provide guidance and, when appropriate, arrange a replacement prescription.
Consumers with questions about the recall can contact Vitruvias Therapeutics at [email protected] or 256-239-9373, Monday through Friday from 9 a.m. to 5 p.m. CT. Anyone who believes they experienced a problem related to the medication should contact a physician or healthcare provider.
The recall is being conducted with the knowledge of the FDA.
Do you or someone you know take thyroid medication? Check your medicine cabinet and share this recall information with others who may need to see it.