US FDA Classifies Vitruvias Thyroid Tablet Recall as Class I

Vitruvias Therapeutics Inc., based in Alabama, initiated a voluntary nationwide recall of one lot of Thyroid Tablets, USP 30 mg on 21 August 2026. The U.S. Food and Drug Administration classified the recall as Class I on 22 September 2026, which is the highest risk category used for recalls in the United States.

Class I Recall

A Class I recall is used when there is a reasonable probability that use of a product will cause serious adverse health consequences or death. The FDA uses three recall classes in the United States: Class I, Class II, and Class III.

Thyroid Tablets, USP 30 mg

The recalled product was Thyroid Tablets, USP 30 mg, a prescription thyroid hormone preparation used in the treatment of hypothyroidism. The affected lot was Lot Number 504950, with National Drug Code 69680-166-00 and an expiry date of 30 September 2026.

Reason for Recall and Health Risks

The recall was linked to a possible superpotent product, which means the tablets may contain more thyroid hormone than intended. Excess thyroid hormone can cause hyperthyroidism symptoms such as weight loss, rapid heart rate, chest pain, and heart rhythm disturbances. Elderly persons, pregnant women, and infants are among the groups at higher risk from excess thyroid hormone exposure.

Important Facts for Exams

• The U.S. Food and Drug Administration is the federal agency that regulates drugs, food, medical devices, and cosmetics in the United States.
• Class I recall is the most serious recall classification used by the FDA.
• Thyroid hormone medicines are used to treat hypothyroidism, a condition in which the thyroid gland does not produce enough hormone.
• Superpotent medicines contain more active ingredient than the labelled strength.

Distribution and Company Status

The affected lot was distributed nationwide in the United States to direct accounts between 31 January 2025 and 30 September 2025. Vitruvias Therapeutics had not received reports of adverse events at the time of the recall announcement on 24 August 2026. The company has ceased operations, and its products were transferred to H2-Pharma.