Glimepiride Tablets — Class II drug recall D-0757-2023
Terminated recall by Amerisource Health Services LLC, reported 2023-05-31, distributed nationwide. CGMP Deviations: recalling drug products following an FDA inspection.
| Recall number | D-0757-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Amerisource Health Services LLC, Columbus, OH, United States |
| Recall initiated | 2023-03-17 |
| Classified | 2023-05-19 |
| Reported by FDA | 2023-05-31 |
| Terminated | 2024-09-06 |
| Distributed | Nationwide (US) |
| Quantity | 63,335 bottles |
| Reason classes | cgmp |
| NDC | 68001-0177-00, 68001-0177-03 |
| Expiration dates | 2023-04-30, 2023-11-30, 2024-01-31, 2024-02-29, 2024-04-30, 2024-09-30, 2025-02-28, 2025-04-30, 2025-06-30 |
Product
Glimepiride Tablets, USP, 1 mg, RX, Packaged as a)100-count bottle, NDC# 68001-177-00; b) 500-count bottle, NDC# 68001-177-03; Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213. INDIA. For BluePoint Laboratories
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-0757-2023. 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.