FDA Drug recall D-1445-2020
Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, 60-count bottle, Rx only, Mfg by: Sun Pharmaceutical Industries, Inc
- FDA Drug
- Class III
- terminated
- Published 2020-08-05
On 2020-08-05 the FDA classified a Class III recall of Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, 60-count bottle, Rx only, Mfg by: Sun Pharmaceutical Industries, Inc by Sun Pharmaceutical Industries, citing cross contamination with other products - OOS discovered during routine stability testing for highest unknown impurity later identified as clozapine.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1445-2020 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2020-07-06 |
| Published | 2020-08-05 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Sun Pharmaceutical Industries |
| Distribution | US |
Product
Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, 60-count bottle, Rx only, Mfg by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 57664-783-86
Reason
Cross contamination with other products - OOS discovered during routine stability testing for highest unknown impurity later identified as clozapine
Identifiers
| code_info | Lot #: AA84106, Exp 9/2021 |
|---|
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-1445-2020%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.