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Vitruvias Recalls One U.S. Lot of 30 mg Thyroid Tablets
Vitruvias Therapeutics is recalling lot 504950 of its 30 mg Thyroid Tablets, USP after testing found a potential superpotency problem.
Vitruvias Therapeutics is voluntarily recalling one lot of Thyroid Tablets, USP 30 mg nationwide after testing confirmed the medication may be superpotent, according to a company announcement published by the U.S. Food and Drug Administration.
The company announced the recall on August 21, 2026. FDA published the notice on August 24. The action covers NDC 69680-166-00, lot 504950, with an expiration date of September 30, 2026.
Vitruvias reported that 3,655 units from the lot were released and 1,955 were sold. The product was distributed nationwide in the United States to the company’s direct accounts between January 31 and September 30, 2025.
The recall is being conducted at the consumer level. Vitruvias said it is notifying wholesalers to stop distribution and arranging for destruction of the affected product.
Thyroid Tablets, USP are used as thyroid hormone replacement therapy for hypothyroidism. The Vitruvias product is a natural preparation derived from porcine thyroid glands and contains levothyroxine, or T4, and liothyronine, or T3. The company’s 30 mg label states that each tablet contains 19 micrograms of levothyroxine and 4.5 micrograms of liothyronine.
A superpotent tablet may expose a patient to more thyroid hormone than the prescribed dose. FDA’s notice says excessive thyroid hormone can lead to hyperthyroidism and symptoms including weight loss, heat intolerance, fatigue, nervousness, muscle weakness, hypertension, chest pain, rapid heart rate and disturbances in heart rhythm.
The notice identifies elderly patients, pregnant women and infants as groups at greater risk from superpotent thyroid medication, particularly with extended use. Excess thyroid hormone in older adults has been associated with adverse cardiac outcomes. Overtreatment during pregnancy has been associated with complications including premature delivery and low birth weight. In infants, overtreatment may adversely affect growth and development.
Vitruvias said it had received no reports of adverse events known to be associated with the recall as of its announcement.
FDA’s handling of the recall comes amid a broader agency focus on animal-derived thyroid medications. The agency states that animal-derived thyroid products are not FDA approved and that they can present concerns involving potency, content uniformity and impurities. FDA estimates that about 1.5 million U.S. patients received prescriptions for animal-derived thyroid medication in 2024.
DailyMed lists the Vitruvias Thyroid Tablets label as a human prescription drug under the marketing category “unapproved drug other.” The label includes a notice that the product has not been found by FDA to be safe and effective and that its labeling has not been approved by the agency.
FDA says professional medical society guidelines recommend synthetic levothyroxine as the preferred treatment for hypothyroidism. However, the agency’s instructions for the current recall do not tell patients to discontinue treatment on their own or to make an unsupervised substitution.
Patients currently taking tablets from lot 504950 should contact their healthcare provider for guidance or a replacement prescription before discontinuing the medication. Consumers who believe they have experienced a problem related to the tablets should contact a physician or other healthcare provider. Adverse reactions and quality problems may also be reported through FDA’s MedWatch program.
The immediate scope remains limited to the identified 30 mg lot. Patients using Vitruvias thyroid medication can determine whether they are affected by comparing the NDC, lot number and expiration date on their bottle with the recall notice and then contacting their prescriber or pharmacy if the identifiers match.
