Zonisamide Capsules USP 50 mg 100 Capsules Rx Only NDC 68462-129-01… — Class II drug recall D-0825-2021
Terminated recall by Glenmark Pharmaceuticals Inc., USA, reported 2021-09-29, distributed nationwide. CGMP Deviations
| Recall number | D-0825-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ, United States |
| Recall initiated | 2021-08-27 |
| Classified | 2021-09-21 |
| Reported by FDA | 2021-09-29 |
| Terminated | 2023-10-04 |
| Distributed | Nationwide (US) |
| Quantity | 15,936 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 | 29190043, 29190044, 29190045 |
| Expiration dates | 2022-05-31 |
Product
Zonisamide Capsules USP 50 mg 100 Capsules Rx Only NDC 68462-129-01 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
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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.