Glimepiride Tablets USP — Class II drug recall D-0393-2023
Terminated recall by Accord Healthcare, Inc., reported 2023-03-08, distributed in PR. CGMP Deviations: recalling drug products following an FDA inspection.
| Recall number | D-0393-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Accord Healthcare, Inc., Durham, NC, United States |
| Recall initiated | 2023-02-07 |
| Classified | 2023-03-02 |
| Reported by FDA | 2023-03-08 |
| Terminated | 2024-04-22 |
| Distributed | PR |
| Countries outside the US | CA |
| Quantity | 469,944 bottles |
| Reason classes | cgmp |
| UPC / GTIN / UDI-DI | 00316729001014, 00316729001168 |
| NDC | 16729-0001, 16729-0001-01, 16729-0001-16, 16729-0001-17, 16729-0002, 16729-0002-01, 16729-0002-16, 16729-0002-17, 16729-0003, 16729-0003-01, 16729-0003-16, 16729-0003-17 |
| Expiration dates | 2023-04-30, 2023-06-30, 2023-08-31, 2023-09-30, 2023-11-30, 2024-01-31, 2024-02-28, 2024-02-29, 2024-03-31, 2024-04-30, 2024-05-31, 2024-07-31, 2024-09-30, 2024-12-31, 2025-02-28, 2025-04-30, 2025-05-31, 2025-06-30, 2025-08-31 |
Product
Glimepiride Tablets USP, 1 mg, Rx Only, Packaged in: a) 100-count bottle NDC 16729-001-01 UPC 3 16729 00101 4; b) 500-count bottle NDC 16729-001-16 UPC 3 16729 00116 8; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA
Reason for recall
CGMP Deviations: recalling drug products following an FDA inspection.
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-0393-2023. 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.