Saxagliptin Tablets 5mg — Class II drug recall D-0332-2025
Ongoing recall by Glenmark Pharmaceuticals Inc., USA, reported 2025-04-16, distributed nationwide. CGMP Deviations
| Recall number | D-0332-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ, United States |
| Recall initiated | 2025-03-13 |
| Classified | 2025-04-08 |
| Reported by FDA | 2025-04-16 |
| Distributed | Nationwide (US) |
| Reason classes | cgmp |
| NDC | 68462-0726, 68462-0726-05, 68462-0726-30, 68462-0726-90, 68462-0727, 68462-0727-05, 68462-0727-14, 68462-0727-30, 68462-0727-90 |
| Lot numbers | 17232460, 17241194, JUN-26, NOV-25 |
Product
Saxagliptin Tablets 5mg, a). 30-count bottle (NDC# 68462-727-30) b.) 90-count bottle ( 68462-727-90), Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.
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-0332-2025. 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.