FDA Drug recall D-0825-2021
Zonisamide Capsules USP 50 mg 100 Capsules Rx Only NDC 68462-129-01 Manufactured by: Glenmark Pharmaceuticals Inc., USA Monroe, NC 28110 Ma…
- FDA Drug
- Class II
- terminated
- Published 2021-09-29
On 2021-09-29 the FDA classified a Class II recall of Zonisamide Capsules USP 50 mg 100 Capsules Rx Only NDC 68462-129-01 Manufactured by: Glenmark Pharmaceuticals Inc., USA Monroe, NC 28110 Ma… by Glenmark Pharmaceuticals Usa, citing CGMP Deviations.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0825-2021 |
| 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 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
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: 29190043 Exp. 05/31/2022; 29190044 Exp. 05/31/2022; 29190045 Exp. 05/31/2022 |
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-0825-2021%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.