Levothyroxine Sodium Tablets USP, 25 mcg, packaged in a) 90-count bottles (NDC 0378-1800-77) and ...
FDA Recall #D-0123-2025 — Class II — November 18, 2024
Product Description
Levothyroxine Sodium Tablets USP, 25 mcg, packaged in a) 90-count bottles (NDC 0378-1800-77) and b) 1000-count bottles (NDC 0378-1800-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.
Reason for Recall
Superpotent Drug and Subpotent Drug: potency failures obtained
Recalling Firm
Viatris Inc — Canonsburg, PA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
34,845 bottes
Distribution
Nationwide within the United States and Puerto Rico
Code Information
Lot #: a) 8181875, Exp. Date Aug 2025; 8174497, Exp. Date April 2025 b) 3209099, Exp. Date Sep 2025; 3206534, Exp. Date Aug 2025; 3196137, Exp. Date April 2025
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated