Vitruvias Therapeutics Inc. is voluntarily recalling nearly 2,000 bottles of Thyroid Tablets, USP, after the product was found to be superpotent, meaning the tablets contain more active ingredient than labeled — a potentially dangerous issue for patients.
The recall affects 1,955 bottles of the 1/2 Grain (30 mg) tablets sold in 100-count bottles.
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The affected product carries NDC 69680-166-00, Lot No. 504950, with an expiration date of Sept. 30, 2026. The tablets are distributed nationwide across the United States.
What makes this recall serious
The recall has been classified as a Class I recall by the U.S. Food and Drug Administration — the most serious classification level, reserved for situations where use of or exposure to the product could cause serious adverse health consequences or death.
Thyroid tablets contain two active hormones: levothyroxine (T4) at 19 micrograms and liothyronine (T3) at 4.5 micrograms per tablet, as labeled. A superpotent drug delivers more of those hormones than stated, which can lead to serious health complications, particularly for patients with underlying heart conditions or those sensitive to thyroid hormone levels.
What patients should do
The recall is ongoing, and consumers who have the affected product should stop using it immediately and contact their healthcare provider.
Notifications to consignees and the public were made by letter. The recall was firm-initiated and voluntary, meaning Vitruvias Therapeutics took action without a formal FDA mandate.
The FDA’s Center Classification Date for this recall was Sept. 22.
Vitruvias Therapeutics is located at 778 N. Dean Road, Suite 600, Auburn, AL 36830. Consumers with questions can contact the company directly.