Zonisamide Capsules — Class II drug recall D-0793-2022
Completed recall by Glenmark Pharmaceuticals Inc., USA, reported 2022-05-04, distributed nationwide. cGMP deviations
| Recall number | D-0793-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ, United States |
| Recall initiated | 2022-04-25 |
| Classified | 2022-04-27 |
| Reported by FDA | 2022-05-04 |
| Distributed | Nationwide (US) |
| Reason classes | cgmp |
| NDC | 68462-0128, 68462-0128-01, 68462-0128-05, 68462-0129, 68462-0129-01, 68462-0129-05, 68462-0130, 68462-0130-01, 68462-0130-05 |
| Lot numbers | 29200053, 29200054 |
| Expiration dates | 2023-04-30 |
Product
Zonisamide Capsules, USP, 100 mg, packaged in: a) 100-count bottle (NDC 68462-130-01); b) 500-count bottle (NDC 68462-130-05), Rx only, Manufactured by: Glenmark Pharmaceuticals, Inc., USA Monroe, NC 28110, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430
Reason for recall
cGMP deviations
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-0793-2022. 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.