Recall Radar

Disclaimer: Recall Radar is an informational summary of public FDA enforcement reports. It is not medical advice. Always confirm details with the FDA, the company, a pharmacist, or a doctor before making health decisions.

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Class IDrug

Thyroid Tablets recall

Summary

VITRUVIAS THERAPEUTICS INC is recalling Thyroid Tablets (drug). According to the FDA report, the reason is: Superpotent Drug. The FDA rated this a Class I: most serious: there is a reasonable chance the product could cause serious health problems or death. Recall status: Ongoing.

Understanding this recall

What happened

Vitruvias Therapeutics is recalling Thyroid Tablets USP (1/2 grain, 30 mg) because testing found them superpotent, meaning stronger than labeled.

Why it matters

A drug that is stronger (superpotent) or weaker (subpotent) than its label says can lead to overdose effects or to the condition not being treated properly. With medicines like thyroid hormone, where dosing is carefully adjusted, even small changes in strength can matter. Too much thyroid hormone can cause symptoms such as a rapid or irregular heartbeat, nervousness or trouble sleeping.

Who should pay attention

Patients prescribed this thyroid medication, and their pharmacists.
Distribution in the FDA report: US Nationwide.

How to check your product

Check the lot number and expiration date on the bottle or pharmacy label. Don't stop taking thyroid medication without talking to your prescriber or pharmacist.
Codes listed by the FDA: Lot # 504950, Exp Date: 09/30/2026.

Based only on the FDA enforcement record plus general public-health background on this type of hazard. Not medical advice; if you have symptoms or concerns, contact a doctor or pharmacist.

Details from the FDA report

Product
Thyroid Tablets, USP, 1/2 Grain (30 mg), Each tablet contains: levothyroxine (T4) 19 mcg, liothyronine (T3) 4.5 mcg, 100 Tablets, Rx only, Distributed by: Vitruvias Therapeutics, Auburn, AL 36830, Product of USA, NDC 69680-166-00.
Reason
Superpotent Drug
Lot / code info
Lot # 504950, Exp Date: 09/30/2026.
Quantity
1955 bottles
Distribution
US Nationwide.
Recalling company
VITRUVIAS THERAPEUTICS INC, Auburn, AL United States
Recall started
August 21, 2026
FDA report date
September 23, 2026
Classification
Class I: Most serious: there is a reasonable chance the product could cause serious health problems or death.
Voluntary / mandated
Voluntary: Firm initiated
Status
Ongoing
Recall number
D-0866-2026

What to do

View the FDA source record (openFDA) · FDA recalls page

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