FDA Drug recall D-1370-2020
Clozapine Tablets USP tablet, 100mg, 500-count bottle, Rx only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road Ea…
- FDA Drug
- Class II
- terminated
- Published 2020-07-01
On 2020-07-01 the FDA classified a Class II recall of Clozapine Tablets USP tablet, 100mg, 500-count bottle, Rx only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road Ea… by Aurobindo Pharma Usa, citing presence of foreign tablet: Consumer complaint of Clozapine Tablets 50mg being present in 500 count bottles of Clozapine Tablets USP 100mg.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1370-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-06-12 |
| Published | 2020-07-01 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Aurobindo Pharma Usa |
| Distribution | US |
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
Presence of foreign tablet: Consumer complaint of Clozapine Tablets 50mg being present in 500 count bottles of Clozapine Tablets USP 100mg.
Identifiers
| ndc | 65862-844-01 |
|---|---|
| ndc | 65862-844-05 |
| ndc | 65862-844-10 |
| ndc | 65862-844-78 |
| ndc | 65862-845-01 |
| ndc | 65862-845-05 |
| ndc | 65862-845-10 |
| ndc | 65862-845-78 |
| ndc | 65862-846-01 |
| ndc | 65862-846-05 |
| ndc | 65862-846-10 |
| ndc | 65862-846-78 |
| ndc | 65862-847-01 |
| ndc | 65862-847-05 |
| ndc | 65862-847-10 |
| ndc | 65862-847-78 |
| code_info | Lot #: CZSC20003-A, Exp 1/2022 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1370-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.