FDA Drug recall D-0792-2022
Zonisamide Capsules, USP, 50 mg, packaged in 100-count bottles, Rx only, Manufactured by: Glenmark Pharmaceuticals, Inc., USA Monroe, NC 28…
- FDA Drug
- Class II
- completed
- Published 2022-05-04
On 2022-05-04 the FDA classified a Class II recall of Zonisamide Capsules, USP, 50 mg, packaged in 100-count bottles, Rx only, Manufactured by: Glenmark Pharmaceuticals, Inc., USA Monroe, NC 28… by Glenmark Pharmaceuticals Usa, citing cGMP deviations.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0792-2022 |
| Classification | Class II |
| Status | completed |
| Initiated | 2022-04-25 |
| Published | 2022-05-04 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Glenmark Pharmaceuticals Usa |
| Distribution | US |
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
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 | Lot #: 29200064, Exp 5/31/2023 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0792-2022%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.