FDA Drug · D-0291-2025

Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), Rx Only, 100 Unit Dose Blister Cards of 10 (10 cards of 10 tablets each) per carton, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Made in India, NDC 51079-443-20.

Class II · Ongoing

Super-Potent Drug: Out of specification potency results were obtained.

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Affected lots / codes — check yours against thisLot 3115773, Exp. 03/31/2025
Recalling firm
Mylan Institutional, Inc., Rockford, IL
Classification
Class II (temporary or reversible harm possible)
Status
Ongoing
Quantity
1,068 cartons
Distribution
Nationwide in the USA
Recall initiated
March 7, 2025
Classified
March 20, 2025
Initiation
Voluntary: Firm initiated
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Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0291-2025%22
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Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.
Check this brand across all 8 databases →