Olanzapine Tablets — Class II drug recall D-0639-2022
Terminated recall by Macleods Pharma Usa Inc, reported 2022-03-09, distributed nationwide. cGmp Deviations
| Recall number | D-0639-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Macleods Pharma Usa Inc, Plainsboro, NJ, United States |
| Recall initiated | 2022-02-16 |
| Classified | 2022-02-28 |
| Reported by FDA | 2022-03-09 |
| Terminated | 2023-10-16 |
| Distributed | Nationwide (US) |
| Quantity | 3,672 bottles |
| Reason classes | cgmp |
| 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 | BOB42029A, BOB4202B |
| Expiration dates | 2022-09 |
Product
Olanzapine Tablets, USP 10 mg, 30-count bottles, Rx only, Manufactured for: Macleods Pharma USA , Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, HImachal Pradesh, India, NDC 33342-070-07.
Reason for recall
cGmp Deviations
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-0639-2022. 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.