Macleods Pharmaceuticals Ltd: Drug Recall

Recall #D-0470-2025 · 05/29/2025

Class III: Low Risk

Recall Details

Recall Number: D-0470-2025
Classification: Class III
Product Type: Drug
Recalling Firm: Macleods Pharmaceuticals Ltd
Status: Ongoing
Date Initiated: 05/29/2025
Location: Mumbai, India
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1,344- 1000 count bottles

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.

Distribution Pattern

Nationwide in the USA

Other Recalls by Macleods Pharmaceuticals Ltd

Class III: Low Risk 06/11/2025

Presence of Foreign Substance- Black hair strand found attached to a tablet in a sealed bottle.
Class II: Risk 11/25/2024

Failed Impurities/Degradation Specifications

View all recalls by Macleods Pharmaceuticals Ltd →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.