Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), Rx Only, 100 Unit Dose Blister Cards of 10...
FDA Recall #D-0291-2025 — Class II — March 7, 2025
Product Description
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.
Reason for Recall
Super-Potent Drug: Out of specification potency results were obtained.
Recalling Firm
Mylan Institutional, Inc. — Rockford, IL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
1,068 cartons
Distribution
Nationwide in the USA
Code Information
Lot 3115773, Exp. 03/31/2025
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated