← FDA ENFORCEMENT
D-0470-2025Class III

Macleods Pharmaceuticals Ltd

Recalling firm
Macleods Pharmaceuticals Ltd
Product type
Drug
Status
Ongoing
Report date
2025-06-18
Distribution
Nationwide in the USA
Product quantity
1,344- 1000 count bottles
Initiated by
Voluntary: Firm initiated
Reason for recall

Presence of a foreign substance: black hair found embedded in tablet.

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.

Code / lot info

Lot #: MLF2401A, Exp 01/31/2026

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.