Macleods Pharmaceuticals Limited recall (Class III): Olanzapine Tablets, USP 5 mg, 30-count bottle, Rx Only, Manufactured For: Macleods Pharma USA, Inc. Princeton,…
Failed Impurities/Degradation Specifications:Organic and unspecified impurities above specification. Product: 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.
- Published by source
- 2026-09-30
- First seen by Reality Radar
- 2026-10-20
- Last verified
- 2026-10-20
Affected
- Manufacturer
- Macleods Pharmaceuticals Limited
- Products
- OLANZAPINE OLANZAPINE Olanzapine Tablets, USP 5 mg, 30-count bottle, Rx Only, Manufactured For: Macleods Pharma USA, Inc. Princeton, NJ, 08540; Manufactured by: Macleods Pharmaceutic
Whether your exact unit is affected depends on the model, serial number and region in the official notice.
What the official notice says
Risk: Class III: Failed Impurities/Degradation Specifications:Organic and unspecified impurities above specification.
Is this affecting you?
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Sources
- openFDA Recall Enforcement Reports Tier A · official published 2026-09-30
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