Vitruvias Therapeutics has voluntarily recalled one lot of its Thyroid Tablets, USP 30 mg after testing confirmed the product may be superpotent, meaning patients could receive more thyroid hormone than intended. The company announced the recall on August 21, and the U.S. Food and Drug Administration published the notice on August 24.
The action is limited to a specific lot, not every Vitruvias thyroid tablet. The affected product carries NDC 69680-166-00, lot number 504950 and an expiration date of September 30, 2026. Vitruvias said 3,655 units were released and 1,955 were sold. The lot was distributed nationwide in the United States to the company’s direct accounts from January 31 through September 30, 2025.
For thyroid replacement therapy, potency matters because small changes in hormone exposure can produce meaningful physiological effects. The recalled tablets contain desiccated thyroid material derived from porcine thyroid glands. According to the current product label, each 30 mg tablet provides 19 micrograms of levothyroxine, or T4, and 4.5 micrograms of liothyronine, or T3.
If a tablet contains more active thyroid hormone than expected, treatment intended to correct hypothyroidism can push a patient toward hyperthyroidism. The recall notice lists possible symptoms including weight loss, heat intolerance, fatigue, nervousness, muscle weakness, high blood pressure, chest pain, a rapid heart rate and abnormal heart rhythms.
The FDA notice identifies elderly patients, pregnant women and infants as groups at greater risk, particularly after extended exposure. Excess thyroid hormone can be especially consequential in people with underlying cardiovascular vulnerability. During pregnancy, overtreatment of hypothyroidism has been associated with maternal and fetal complications including premature delivery and low birth weight. In infants, excessive thyroid hormone exposure may interfere with growth and development.
Vitruvias said it had not received reports of adverse events known to be related to the recalled lot at the time of the announcement.
The recall also lands during a broader FDA effort focused on animal-derived thyroid medications. FDA says these products, sometimes called desiccated thyroid extract, are not FDA approved. The agency estimates that about 1.5 million U.S. patients received prescriptions for animal-derived thyroid medications in 2024. By comparison, about 22 million patients received levothyroxine prescriptions through U.S. retail and mail-order pharmacies that year.
FDA has said animal-derived products can present particular quality and dosing challenges because they come from a complex biological source. The agency notes that tablets produced from the same animal-derived source material may not always deliver identical hormone levels. It also says professional medical society guidelines recommend synthetic levothyroxine as the preferred treatment for hypothyroidism.
DailyMed currently lists the Vitruvias Thyroid Tablets label under the marketing status “unapproved drug other” and states that the product has not been found by FDA to be safe and effective and that its labeling has not been approved by FDA. That regulatory status is separate from the immediate recall, which concerns the confirmed potential for excessive potency in one 30 mg lot.
Patients who have Vitruvias Thyroid Tablets, USP 30 mg should check the bottle for NDC 69680-166-00 and lot 504950. FDA and the company advise patients taking tablets from that lot not to stop treatment on their own. Instead, they should contact their healthcare provider for guidance and, if needed, a replacement prescription.
Anyone who has experienced a problem that may be related to the medication should contact a physician or other healthcare professional. Adverse reactions and product-quality problems can also be reported through FDA’s MedWatch program. For patients on long-term thyroid replacement, the next step is not a sudden interruption of therapy but a verified bottle check and a clinician-guided plan for replacing the recalled medicine.
