Carvedilol Tablets USP 6 — Class II drug recall D-0449-2025
Ongoing recall by Glenmark Pharmaceuticals Inc., USA, reported 2025-06-04, distributed nationwide. CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
| Recall number | D-0449-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ, United States |
| Recall initiated | 2025-02-28 |
| Classified | 2025-05-28 |
| Reported by FDA | 2025-06-04 |
| 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 | 19231164, 19231174, 19231199, 19231448, 19231517, 19231527, 19231566, 19231568, 19231595, 19231618, 19231634, 19231638, 19232043, 19232051, 19232064, 19232322, 19232324, 19232365, 19232380, 19232389, 19232736, 19232743, 19232746, 19232756, 19232757, 19233369, 19233371, 19233405, 19233416, 19234162, 19234165, 19234183, 19234192, 19234204, 19234223, 19234242, 19234243, 19234263, 19234743, 19234774 and 20 more |
Product
Carvedilol Tablets USP 6.25 mg, a.)100-count bottle (NDC 68462-163-01), b.) 500-count bottle (NDC 68462-163-05) Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430.
Reason for recall
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
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-0449-2025. 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.