Glimepiride USP — Class II drug recall D-0559-2023
Terminated recall by PD-Rx Pharmaceuticals, Inc., reported 2023-05-10, distributed nationwide. CGMP deviations.
| Recall number | D-0559-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | PD-Rx Pharmaceuticals, Inc., Oklahoma City, OK, United States |
| Recall initiated | 2023-04-06 |
| Classified | 2023-05-01 |
| Reported by FDA | 2023-05-10 |
| Terminated | 2024-04-30 |
| Distributed | Nationwide (US) |
| Quantity | 186 bottles |
| Reason classes | cgmp |
| NDC | 43063-0587-90 |
| Lot numbers | A22B45, A23D07, B23B25, B23B55, C22A73, C22D28, E22E41, F22B68, G22A29, H22B97, K22A36, K22B99 |
| Expiration dates | 2024-01-31, 2024-03-31, 2024-10-31, 2025-06-30 |
Product
Glimepiride USP, 4 mg, 90 count-bottles, Rx only, Intas Pharm. Limited Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127, NDC 43063-0587-90
Reason for recall
CGMP deviations.
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-0559-2023. 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.