Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000 bottles, Rx Only, Manufactured for Acc...
FDA Recall #D-0394-2025 — Class II — April 10, 2025
Product Description
Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-447-17
Reason for Recall
Subpotent
Recalling Firm
ACCORD HEALTHCARE, INC. — Raleigh, NC
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
4,888 Bottles
Distribution
Nationwide US.
Code Information
Lot # D2300323, Exp Date: 01/2026
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated