FDA Recall D-0154-2025

Macleods Pharmaceuticals Ltd

Class II Ongoing 535 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

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.

Lot / code: Lot# BOB12318A Exp 07/31/2027

Quantity: 15,744 30-count bottles

Reason for recall

Failed Impurities/Degradation Specifications

Recall record

Recall number: D-0154-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the USA
Recall initiated: 2024-11-25
Classified by FDA Center: 2024-12-19
FDA published: 2024-12-25
Recalling firm: Macleods Pharmaceuticals Ltd

Drug identification

Brand name(s): OLANZAPINE
Generic name(s): OLANZAPINE
Manufacturer(s): Macleods Pharmaceuticals Limited
NDC(s): 33342-067, 33342-068, 33342-069, 33342-070, 33342-071, 33342-072
Route(s): ORAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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