Levothyroxine Sodium Tablets, USP 112 mcg (0.112mg), 1000 tablets, Rx Only, Manufactured for: Mac...
FDA Recall #D-0470-2025 — Class III — May 29, 2025
Product Description
Levothyroxine Sodium Tablets, USP 112 mcg (0.112mg), 1000 tablets, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540. Manufactured by: Macleods Pharmaceuticals Ltd. Sarigam, Valsad, Gujarat, India, NDC 33342-398-44.
Reason for Recall
Presence of a foreign substance: black hair found embedded in tablet.
Recalling Firm
Macleods Pharmaceuticals Ltd — Mumbai
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
1,344- 1000 count bottles
Distribution
Nationwide in the USA
Code Information
Lot #: MLF2401A, Exp 01/31/2026
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated