Carvedilol Tablets — Class II drug recall D-0587-2025
Ongoing recall by Glenmark Pharmaceuticals Inc., USA, reported 2025-08-20, distributed nationwide. CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-reco
| Recall number | D-0587-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ, United States |
| Recall initiated | 2025-08-06 |
| Classified | 2025-08-14 |
| Reported by FDA | 2025-08-20 |
| Distributed | Nationwide (US) |
| Reason classes | cgmp, specification failure |
| NDC | 68462-0162, 68462-0162-01, 68462-0162-05, 68462-0162-10, 68462-0162-18, 68462-0162-60, 68462-0163, 68462-0163-01, 68462-0163-05, 68462-0163-10, 68462-0163-18, 68462-0163-60, 68462-0164, 68462-0164-01, 68462-0164-05, 68462-0164-10, 68462-0164-18, 68462-0164-60, 68462-0165, 68462-0165-01, 68462-0165-05, 68462-0165-10, 68462-0165-18, 68462-0165-60 |
| Lot numbers | 17241257, 17241258, 17241279 |
| Expiration dates | 2026-06 |
Product
Carvedilol Tablets, USP, 12.5 mg, 500 Tablets per carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-Dhar, Madhya Pradesh 454 775, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 47430, NDC 68462-164-05
Reason for recall
CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
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-0587-2025. 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.