Vitruvias Therapeutics is recalling a single lot of its thyroid medication that was distributed nationwide after testing revealed the tablets were more potent than labeled.
The Auburn, Alabama‑based company voluntarily recalled Lot 504950 of its 30 mg Thyroid Tablets, USP, at the consumer level due to the possibility that the tablets may be superpotent.
The FDA released the company’s announcement on Monday.
Consuming tablets that are overly potent can lead to hyperthyroidism, presenting with symptoms such as weight loss, heat intolerance, fatigue, nervousness, muscle weakness, hypertension, chest pain, rapid heart rate, and arrhythmias, per the company.
Vitruvias Therapeutics is recalling a single lot of its 30 mg Thyroid Tablets, USP, after testing confirmed the product was more potent than intended.
(FDA / Unknown)
Elderly individuals, pregnant women, and infants are at heightened risk for adverse effects from excessive thyroid hormone levels, especially with prolonged use, the company noted.
Elevated thyroid hormone levels have been linked to cardiac issues in older patients, while overtreatment during pregnancy is associated with premature birth and low birth weight. In infants, excessive hormone can impair growth and developmental progress.
Vitruvias Therapeutics reported that it has received no adverse events directly linked to this recall.
The recalled product bears NDC 69680‑166‑00 and is dated to September 30, 2026. The company distributed 3,655 units, of which 1,955 had been sold.
The recall notice was posted by the FDA.
(Sarah Silbiger/Getty Images / Getty Images)
The affected lot was distributed nationwide to the company’s direct accounts from January 31, 2025, through September 30, 2025.
Thyroid, USP is derived from porcine thyroid glands and contains levothyroxine and liothyronine; it is indicated for the treatment of hypothyroidism, or underactive thyroid.
Vitruvias Therapeutics is informing wholesalers to cease distribution of the recalled product and arrange for its destruction.
A pharmacist removes a medication from a pharmacy shelf in Provo, Utah.
(George Frey/Bloomberg via Getty Images, File / Getty Images)
Patients who are currently taking tablets from the affected lot should not discontinue the medication without first consulting their healthcare provider for guidance or a replacement prescription, the company advised.
A Vitruvias Therapeutics representative did not promptly respond to FOX Business’s request for further information.
Consumers with inquiries may contact Vitruvias Therapeutics at safety@vitruvias.com or by phone at 256‑239‑9373.
Anyone who believes they may have experienced adverse effects related to the medication should consult a physician or other healthcare provider.
The recall is being undertaken with FDA awareness.
