Thyroid Tablets Recalled Nationwide Over ‘Superpotency’ Risk That Could Cause Hyperthyroidism
A nationwide recall has been issued for a lot of thyroid tablets after testing found the medication could be “superpotent,” meaning it may contain more thyroid hormone than intended and potentially cause hyperthyroidism, the U.S. Food and Drug Administration said.
The recall involves Thyroid Tablets, USP 30 mg manufactured by Vitruvias Therapeutics Inc. The company voluntarily recalled one lot, Lot No. 504950, at the consumer level after testing confirmed the potential for the product to be more potent than intended. The FDA published the recall announcement on August 24, 2026.
The affected tablets can be identified by the National Drug Code, or NDC, 69680-166-00. The recalled lot has an expiration date of September 30, 2026.
According to the FDA, 3,655 units of the affected product were released, with 1,955 units sold. The lot was distributed nationwide in the United States through Vitruvias Therapeutics’ direct accounts between January 31, 2025, and September 30, 2025.
Thyroid Tablets, USP are used to treat hypothyroidism, a condition in which the body does not produce enough thyroid hormone. The recalled product is a natural thyroid preparation derived from porcine thyroid glands and contains levothyroxine and liothyronine.
The concern is that excessive amounts of thyroid hormone can have the opposite effect, causing hyperthyroidism, also known as an overactive thyroid. The FDA and manufacturer warn that taking superpotent tablets could result in symptoms including weight loss, heat intolerance, fatigue, nervousness, muscle weakness, high blood pressure, chest pain, rapid heartbeat and disturbances in heart rhythm.
Certain groups face greater risks from excessive thyroid hormone exposure. The FDA specifically identifies elderly people, pregnant women and infants as populations of particular concern, especially when exposure occurs over an extended period.
For older adults, excessive thyroid hormone levels can have potentially serious effects on cardiovascular health. During pregnancy, overtreatment of hypothyroidism can increase the risk of complications affecting both the mother and fetus, including premature delivery and low birth weight. In infants, excessive thyroid hormone treatment may negatively affect growth and development.
Despite the potential risks, Vitruvias Therapeutics said it has not received any reports of adverse events known to be associated with the recalled product as of the recall announcement.
The company is notifying wholesalers by email and telephone and is arranging for recalled products to be destroyed. The action is intended to stop further distribution of the affected lot.
Patients who believe they may have the recalled tablets should first check the information printed on their medication packaging. The lot number, product description, NDC number and expiration date can be used to determine whether the medication is part of the recall.
Importantly, patients currently taking Thyroid Tablets from Lot 504950 are advised not to stop taking the medication on their own without first contacting their healthcare provider. The FDA says patients should seek guidance about continued treatment and, if necessary, obtain a replacement prescription.
That warning is particularly important because thyroid hormone replacement is often used as ongoing treatment for hypothyroidism. Suddenly stopping prescribed thyroid medication without medical guidance can create its own health concerns, making it important for patients to discuss the recall with their doctor, pharmacist or other healthcare professional.
Consumers who experience problems they believe could be related to the recalled medication should contact their healthcare provider. The FDA also encourages adverse reactions or product quality problems to be reported through its MedWatch safety reporting program.
The recall is another reminder that medication potency is critical for thyroid treatments. Even relatively small differences in hormone levels can matter because thyroid hormones influence metabolism, heart function and numerous other processes throughout the body.
Consumers with questions about the recall can contact Vitruvias Therapeutics at [email protected] or by telephone at 256-239-9373 during the company’s listed business hours.
For anyone taking thyroid medication, the recall does not mean that all thyroid tablets have been affected. The FDA notice specifically identifies one lot of Vitruvias Therapeutics Thyroid Tablets, USP 30 mg.
Patients should therefore check their medication carefully rather than assuming that their prescription is part of the recall. Anyone uncertain about a product’s status should contact a pharmacist or healthcare provider for assistance.
The latest thyroid tablets recall highlights the importance of checking medication labels and responding promptly to official safety alerts. While no related adverse events had been reported by the manufacturer at the time of the announcement, the potential for superpotency means affected products should not be ignored.
For patients with Lot 504950, the safest next step is to contact a healthcare professional before making changes to treatment and to follow official instructions concerning replacement, return or disposal of the recalled medication.
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