Zonisamide Capsules — Class II drug recall D-0792-2022
Completed recall by Glenmark Pharmaceuticals Inc., USA, reported 2022-05-04, distributed nationwide. cGMP deviations
| Recall number | D-0792-2022 |
|---|---|
| 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) |
| Quantity | 12,003 bottles |
| 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 | 29200064 |
| Expiration dates | 2023-05-31 |
Product
Zonisamide Capsules, USP, 50 mg, packaged in 100-count bottles, Rx only, Manufactured by: Glenmark Pharmaceuticals, Inc., USA Monroe, NC 28110, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 68462-129-01
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-0792-2022. 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.