Macleods Pharmaceuticals Ltd: Drug Recall

Recall #D-0154-2025 · 11/25/2024

Class II: Risk

Recall Details

Recall Number: D-0154-2025
Classification: Class II
Product Type: Drug
Recalling Firm: Macleods Pharmaceuticals Ltd
Status: Ongoing
Date Initiated: 11/25/2024
Location: Mumbai, India
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 15,744 30-count bottles

Reason for Recall

Failed Impurities/Degradation Specifications

Product Description

Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540, Manufactured for: Macleods Pharma USA Inc. Princeton, NJ,08540: Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi Himachal Pradesh, INDIA, NDC 33342-067-07.

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 III: Low Risk 05/29/2025

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

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.