Thyroid Tablets, USP, 1/2 Grain (30 mg), Each tablet contains: levothyroxine (T4) 19 mcg, liothyronine (T3) 4.5 mcg, 100
Summary
The FDA issued a Class I for Thyroid Tablets, USP, 1/2 Grain (30 mg), Each tablet contains: levothyroxine (T4 by VITRUVIAS THERAPEUTICS INC. Reason: Superpotent Drug.
Details
Source
Drug Recall
External ID
D-0866-2026
Action Date
2026-09-23
Status
Ongoing
Category
drug
Product Description
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.
Lot/Code Info: Lot # 504950, Exp Date: 09/30/2026.
Quantity Affected: 1955 bottles
Reason for Recall
Superpotent Drug
Distribution
US Nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-08-21
Company
Auburn, AL
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 17 drug recalls issued in the same week, part of 66 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (VITRUVIAS THERAPEUTICS INC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does VITRUVIAS THERAPEUTICS INC have FDA actions?
This is the only FDA action we have on record for VITRUVIAS THERAPEUTICS INC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0866-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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