Ranolazine Extended-Release Tablets 500mg — Class II drug recall D-0092-2024
Ongoing recall by Glenmark Pharmaceuticals Inc., USA, reported 2023-11-15, distributed nationwide. Failed Dissolution Specifications: Out of specification for dissolution.
| Recall number | D-0092-2024 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ, United States |
| Recall initiated | 2023-10-23 |
| Classified | 2023-11-07 |
| Reported by FDA | 2023-11-15 |
| Distributed | Nationwide (US) |
| Quantity | 16,944 bottles |
| Reason classes | specification failure |
| NDC | 68462-0319, 68462-0319-05, 68462-0319-60, 68462-0320, 68462-0320-05, 68462-0320-60 |
| Lot numbers | 17230388 |
| Expiration dates | 2025-01-31 |
Product
Ranolazine Extended-Release Tablets 500mg, 60 Tablets per bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur Dist - Dhar, Madhya Pradesh - 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-319-60.
Reason for recall
Failed Dissolution Specifications: Out of specification for dissolution.
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-0092-2024. 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.