Mumbai, India
Macleods Pharmaceuticals Ltd recalls
4 recalls recorded since 2018, most recently on 27 August 2026. 4 are listed as ongoing. Status and classification are as published by the FDA.
Recalls4
Ongoing (FDA)4
Terminated or completed0
Class I (FDA)0
Ongoing Class III Drugs
- Recall started
- 27 August 2026
- Reason
- Failed Impurities/Degradation Specifications:Organic and unspecified impurities above specification.
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0867-2026
- Olanzapine Tablets, USP 5 mg, 30-count bottle, Rx Only, Manufactured For: Macleods Pharma USA, Inc. Princeton, NJ, 08540; Manufactured by: Macleods Pharmaceuticals, Ltd, Baddi, Himachal Pradesh, INDIA, NDC 33342-068-07.
Ongoing Class III Drugs
- Recall started
- 11 June 2025
- Reason
- Presence of Foreign Substance- Black hair strand found attached to a tablet in a sealed bottle.
- Distribution
- U.S. Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0509-2025
- Famciclovir Tablets, USP 500 mg, 30-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Manufactured by: Macleods Pharmaceuticals Ltd., Daman, India NDC# 33342-026-07.
Ongoing Class III Drugs
- Recall started
- 29 May 2025
- Reason
- Presence of a foreign substance: black hair found embedded in tablet.
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0470-2025
- 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,
Ongoing Class II Drugs
- Recall started
- 25 November 2024
- Reason
- Failed Impurities/Degradation Specifications
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0154-2025
- 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 Pharmac
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.