The recalled 30-mg tablets, Lot 504950, were distributed nationwide from Jan. 31 through Sept. 30, 2025, and expire Sept. 30, 2026. Patients taking pills from the lot should not stop treatment without first contacting their health care provider for guidance or a replacement prescription, according to the company’s FDA-posted announcement.
Vitruvias Therapeutics Inc. recalled the lot of 30-mg thyroid tablets after testing confirmed they could be superpotent.
Labeled as Thyroid Tablets, USP 30 mg, and branded as Vitruvias Therapeutics, the medication is used to treat hypothyroidism, but a superpotent dose could cause hyperthyroidism, the company said.
The FDA said 3,655 units from the lot were released and 1,955 were sold.
Taking superpotent thyroid tablets can lead to overactive thyroid, which can result in weight loss, fatigue, muscle weakness, hypertension, chest pain, rapid heart rate or heart rhythm disturbances and other symptoms.
Older adults, pregnant women and infants are at higher risk from superpotent thyroid medication, especially with extended use. In older adults, it can lead to cardiac issues. In pregnant women, “overtreatment” of hypothyroidism during pregnancy is linked to a higher rate of fetal and maternal complications. The FDA said overtreatment also may affect growth and development in infants.
Hypothyroidism is a condition in which the thyroid gland doesn’t produce enough thyroid hormone, often described as an underactive thyroid, according to the Mayo Clinic. Hyperthyroidism, or overactive thyroid, occurs when the thyroid gland produces too much hormone.
Vitruvias Therapeutics said it had received no reports of adverse events known to be related to the recalled tablets as of the announcement.
Vitruvias Therapeutics said it was notifying its wholesalers by email and phone to discontinue distribution of the recalled lot. The company said consumers taking medication from the affected lot should contact their health care provider before stopping treatment and for guidance or a replacement prescription.
Any adverse reactions or quality issues related to this recall can be reported to the FDA’s MedWatch Adverse Event Reporting system.
The Houston Chronicle has reached out to Vitruvias Therapeutics Inc. for comment. Vitruvias is based in Auburn, Ala.