FDA Drug recall D-0826-2021
Zonisamide Capsules USP 100 mg Rx Only Manufactured by: Glenmark Pharmaceuticals Inc., USA Monroe, NC 28110 Manufactured for: Glenmark Phar…
- FDA Drug
- Class II
- terminated
- Published 2021-09-29
On 2021-09-29 the FDA classified a Class II recall of Zonisamide Capsules USP 100 mg Rx Only Manufactured by: Glenmark Pharmaceuticals Inc., USA Monroe, NC 28110 Manufactured for: Glenmark Phar… by Glenmark Pharmaceuticals Usa, citing CGMP Deviations.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0826-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-08-27 |
| Published | 2021-09-29 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Glenmark Pharmaceuticals Usa |
| Distribution | US |
Product
Zonisamide Capsules USP 100 mg Rx Only Manufactured by: Glenmark Pharmaceuticals Inc., USA Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 a) 100 Capsules NDC 68462-130-01; b) 500 Capsules NDC 68462-130-05
Reason
CGMP Deviations
Identifiers
| ndc | 68462-128-01 |
|---|---|
| ndc | 68462-128-05 |
| ndc | 68462-129-01 |
| ndc | 68462-129-05 |
| ndc | 68462-130-01 |
| ndc | 68462-130-05 |
| code_info | Lots: a) 29200014 Exp. 02/28/2023; 29200015 Exp. 03/31/2023; 29200016 Exp. 03/31/2023; 29200030 Exp. 05/31/2023; 292000…Lots: a) 29200014 Exp. 02/28/2023; 29200015 Exp. 03/31/2023; 29200016 Exp. 03/31/2023; 29200030 Exp. 05/31/2023; 29200031 Exp. 05/31/2023; 29200032 Exp. 05/31/2023; 29200033 Exp. 06/30/2023; 29200037 Exp. 06/30/2023; 29200038 Exp. 06/30/2023; 29200039 Exp. 07/31/2023; 29200041 Exp. 07/31/2023; 29200042 Exp. 07/31/2023; 29200048 Exp. 08/31/2023; 29200049 Exp. 08/31/2023; 29200050 Exp. 08/31/2023; 29200072 Exp. 11/30/2023; 29200073 Exp. 11/30/2023; 29200074 Exp. 11/30/2023; 29200075 Exp. 11/30/2023; 29200076 Exp. 11/30/2023; b) 29200014 Exp. 02/28/2023; 29200015 Exp. 03/31/2023; 29200016 Exp. 03/31/2023 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0826-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.