Clozapine Tablets USP tablet — Class II drug recall D-1370-2020
Terminated recall by Aurobindo Pharma USA Inc., reported 2020-07-01, distributed nationwide. Presence of foreign tablet: Consumer complaint of Clozapine Tablets 50mg being present in 500 count bottles of
| Recall number | D-1370-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Aurobindo Pharma USA Inc., East Windsor, NJ, United States |
| Recall initiated | 2020-06-12 |
| Classified | 2020-06-30 |
| Reported by FDA | 2020-07-01 |
| Terminated | 2022-12-21 |
| Distributed | Nationwide (US) |
| Quantity | 1,440 bottles |
| NDC | 65862-0844, 65862-0844-01, 65862-0844-05, 65862-0844-10, 65862-0844-78, 65862-0845, 65862-0845-01, 65862-0845-05, 65862-0845-10, 65862-0845-78, 65862-0846, 65862-0846-01, 65862-0846-05, 65862-0846-10, 65862-0846-78, 65862-0847, 65862-0847-01, 65862-0847-05, 65862-0847-10, 65862-0847-78 |
| Lot numbers | CZSC20003-A |
| Expiration dates | 2022-01 |
Product
Clozapine Tablets USP tablet, 100mg, 500-count bottle, Rx only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520, Made in India, NDC 65862-846-05
Reason for recall
Presence of foreign tablet: Consumer complaint of Clozapine Tablets 50mg being present in 500 count bottles of Clozapine Tablets USP 100mg.
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-1370-2020. 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.