Clonazepam Orally Disintegrating Tablets — Class II drug recall D-1155-2022
Terminated recall by SUN PHARMACEUTICAL INDUSTRIES INC, reported 2022-06-29, distributed nationwide. Failed Tablet/Capsule Specification; oversized tablet found in a bottle
| Recall number | D-1155-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | SUN PHARMACEUTICAL INDUSTRIES INC, Princeton, NJ, United States |
| Recall initiated | 2022-06-03 |
| Classified | 2022-06-22 |
| Reported by FDA | 2022-06-29 |
| Terminated | 2023-08-18 |
| Distributed | Nationwide (US) |
| Quantity | 4,608 bottles |
| NDC | 57664-0783-68 |
| Lot numbers | MHC1430A |
| Expiration dates | 2023-09 |
Product
Clonazepam Orally Disintegrating Tablets, USP, 0.125mg, Rx Only, 60 Tablets, Mfd. by: Sun Pharmaceutical Industries Ltd. Mumbai, India, Dist. by: Sun Pharmaceutical Industries In., Cranbury, NJ 08512, NDC 57664-783-68, packaged in bottles.
Reason for recall
Failed Tablet/Capsule Specification; oversized tablet found in a bottle
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-1155-2022. 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.