Clonazepam Orally Disintegrating Tablets — Class III drug recall D-1445-2020
Terminated recall by SUN PHARMACEUTICAL INDUSTRIES INC, reported 2020-08-05, distributed nationwide. Cross contamination with other products - OOS discovered during routine stability testing for highest unknown
| Recall number | D-1445-2020 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | SUN PHARMACEUTICAL INDUSTRIES INC, Princeton, NJ, United States |
| Recall initiated | 2020-07-06 |
| Classified | 2020-07-30 |
| Reported by FDA | 2020-08-05 |
| Terminated | 2023-06-08 |
| Distributed | Nationwide (US) |
| Quantity | 3,516 bottles |
| Reason classes | specification failure |
| NDC | 57664-0783-86 |
| Lot numbers | AA84106 |
| Expiration dates | 2021-09 |
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 for recall
Cross contamination with other products - OOS discovered during routine stability testing for highest unknown impurity later identified as clozapine
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-1445-2020. 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.