Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 1000-count bottle, Rx Only, Manufactured fo...
FDA Recall #D-0523-2025 — Class II — June 20, 2025
Product Description
Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-455-17
Reason for Recall
Subpotent Drug: Assay below the approved specification
Recalling Firm
ACCORD HEALTHCARE, INC. — Raleigh, NC
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
4,921 bottles
Distribution
Nationwide in the USA
Code Information
Lot #D2300076, Exp Date: 12/31/2025
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated