Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000 bottles, Rx Only, Manufactured for Acco...
FDA Recall #D-0395-2025 — Class II — April 10, 2025
Product Description
Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 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 16729-448-17.
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
4,872 Bottles
Distribution
Nationwide US.
Code Information
Lot # D2400547, Exp Date: 02/2026
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated