Key Takeaway:
- FDA classifies recall as Class I: The highest-risk category applies to one lot of Vitruvias Therapeutics’ 30 mg thyroid tablets.
- Tablets may be superpotent: Lot 504950 was recalled because the medicine could be stronger than intended and may cause hyperthyroid effects.
- Patients should contact providers: People taking the recalled tablets should not stop treatment without first consulting a health care professional.
The FDA Thyroid Tablet Recall has received the agency’s highest-risk classification after Vitruvias Therapeutics recalled one lot of 30 mg thyroid tablets because the potentially superpotent medicine could cause serious health effects.
FDA Raises Recall To Class I
The FDA Thyroid Tablet Recall received a Class I classification on Sept. 22, the agency’s most serious recall designation. Vitruvias Therapeutics initiated the nationwide recall in August after testing confirmed the tablets could contain more thyroid hormone than intended.
The FDA defines a Class I recall as one involving a reasonable probability that using or being exposed to a recalled product could cause serious health consequences. The agency says such recalls can involve immediate, life-threatening risks.
Vitruvias announced the recall Aug. 21, and the FDA published the company’s notice Aug. 24. The company said at the time that it had not received reports of adverse events known to be related to the recall.
The FDA’s recall guidance states that it oversees a company’s recall strategy and assesses whether the company is taking sufficient steps to remove a defective or potentially harmful drug from the market.
Recalled Lot Reached Nationwide
The recall covers Thyroid Tablets, USP 30 mg, from lot 504950. The product carries National Drug Code 69680-166-00 and an expiration date of Sept. 30, 2026.
According to the FDA notice, Vitruvias released 3,655 units from the affected lot and sold 1,955. The products were distributed nationwide through the company’s direct accounts between Jan. 31 and Sept. 30, 2025.
The tablets are a natural thyroid preparation containing levothyroxine and liothyronine. They are used to treat hypothyroidism, a condition in which the thyroid gland does not produce enough thyroid hormone.
The company is notifying wholesalers to stop distributing the affected product and is arranging for recalled units to be destroyed, according to the FDA-posted notice.
Superpotency Can Raise Health Risks
The FDA notice says taking superpotent thyroid tablets can cause hyperthyroidism, or an overactive thyroid. Reported potential effects include weight loss, heat intolerance, fatigue, nervousness, muscle weakness, high blood pressure, chest pain, rapid heart rate, and heart rhythm disturbances.
The notice says older adults, pregnant women and infants may face greater risks from excessive thyroid hormone exposure, particularly when it occurs over an extended period. In older adults, excess thyroid hormone has been associated with adverse cardiac outcomes, while overtreatment during pregnancy or infancy can create additional health concerns.
Patients taking tablets from lot 504950 should not stop the medicine without first contacting a health care provider, according to Vitruvias’ recall notice. Patients may need guidance about continuing treatment or obtaining a replacement prescription.
Consumers with questions can contact Vitruvias Therapeutics at safety@vitruvias.com or 256-239-9373, Monday through Friday from 9 a.m. to 5 p.m. Central Time. The FDA also advises consumers to report adverse reactions or quality problems through its MedWatch program.
