A thyroid medication recall initiated last month has been upgraded to the highest risk level, according to an enforcement report shared by the Food and Drug Administration (FDA).1

On Sept. 22, a recall of one lot of thyroid tablets distributed by Vitruvias Therapeutics Inc. was categorized as a Class I recall, the highest from the FDA. The medication was initially recalled on Aug. 21 after testing confirmed that the drug may be superpotent, or stronger than intended.2

Which Thyroid Medication Was Recalled?

• Medication: Thyroid Tablets, USP, 1/2 Grain (30 mg)—each tablet contains: levothyroxine (T4) 19 mcg, liothyronine (T3) 4.5 mcg
• Bottle size: 100 tablets
• NDC: 69680-166-00
• Lot number: 504950
• Expiration date: 09/30/2026
• Affected quantity: 1,955 bottles

The lot of medication was distributed nationwide to Vitruvias Therapeutics’ direct accounts from Jan. 31, 2025, to Sept. 30, 2025.

The product was recalled after testing confirmed it could be superpotent, or stronger than intended. Using superpotent thyroid tablets can cause an overactive thyroid, leading to symptoms including weight loss, hypertension, and rapid heart rate. The patients at greatest risk include pregnant women, infants, and the elderly.

The FDA’s Class I categorization of the recall indicates that there’s a reasonable probability the drugs could cause serious health consequences or death.3

What You Should Do

After the initial recall, Vitruvias Therapeutics notified its wholesalers by email and phone to stop distributing and destroy the recalled product.2

The company recommended that patients currently taking the medication do not discontinue use without first contacting their healthcare provider for further guidance or a replacement prescription.

No adverse effects have been reported in connection to the recall, but consumers are urged to contact their physician or healthcare provider if they experience any problems that may be related to taking the recalled drug.