← FDA ENFORCEMENT
D-0154-2025Class II

Macleods Pharmaceuticals Ltd

Recalling firm
Macleods Pharmaceuticals Ltd
Product type
Drug
Status
Ongoing
Report date
2024-12-25
Distribution
Nationwide in the USA
Product quantity
15,744 30-count bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
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.

Code / lot info

Lot# BOB12318A Exp 07/31/2027

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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.