Zonisamide Capsules USP — Class II drug recall D-0888-2022
Terminated recall by Direct Rx, reported 2022-06-01, distributed nationwide. CGMP Deviations: Gaps in the quality system in the Quality Control microbiology laboratory.
| Recall number | D-0888-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Direct Rx, Dawsonville, GA, United States |
| Recall initiated | 2022-05-13 |
| Classified | 2022-05-20 |
| Reported by FDA | 2022-06-01 |
| Terminated | 2024-09-30 |
| Distributed | Nationwide (US) |
| Quantity | 16 bottles |
| Reason classes | microbial contamination, cgmp |
| NDC | 61919-0775-90 |
| Lot numbers | 23JY2124 |
| Expiration dates | 2023-06-30 |
Product
Zonisamide Capsules USP, 100 mg, 90-count bottle, Rx Only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 61919-775-90
Reason for recall
CGMP Deviations: Gaps in the quality system in the Quality Control microbiology laboratory.
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-0888-2022. 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.