Olanzapine Tablets — Class II drug recall D-0154-2025
Ongoing recall by Macleods Pharmaceuticals Ltd, reported 2024-12-25, distributed nationwide. Failed Impurities/Degradation Specifications
| Recall number | D-0154-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Macleods Pharmaceuticals Ltd, Mumbai, India |
| Recall initiated | 2024-11-25 |
| Classified | 2024-12-19 |
| Reported by FDA | 2024-12-25 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 33342-0067, 33342-0067-07, 33342-0067-11, 33342-0067-12, 33342-0067-44, 33342-0068, 33342-0068-07, 33342-0068-11, 33342-0068-12, 33342-0068-44, 33342-0069, 33342-0069-07, 33342-0069-11, 33342-0069-12, 33342-0069-44, 33342-0070, 33342-0070-07, 33342-0070-11, 33342-0070-12, 33342-0070-15, 33342-0070-44, 33342-0071, 33342-0071-07, 33342-0071-11, 33342-0071-12 and 8 more |
| Lot numbers | BOB12318A |
| Expiration dates | 2027-07-31 |
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.
Reason for recall
Failed Impurities/Degradation Specifications
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0154-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.