FDA Drug recall D-0587-2025
Carvedilol Tablets, USP, 12.5 mg, 500 Tablets per carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pha…
- FDA Drug
- Class II
- ongoing
- Published 2025-08-20
On 2025-08-20 the FDA classified a Class II recall of Carvedilol Tablets, USP, 12.5 mg, 500 Tablets per carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pha… by Glenmark Pharmaceuticals Usa, citing CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0587-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-08-06 |
| Published | 2025-08-20 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Glenmark Pharmaceuticals Usa |
| Distribution | US |
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
CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
Identifiers
| ndc | 68462-162-60 |
|---|---|
| ndc | 68462-162-01 |
| ndc | 68462-162-18 |
| ndc | 68462-162-05 |
| ndc | 68462-162-10 |
| ndc | 68462-163-60 |
| ndc | 68462-163-01 |
| ndc | 68462-163-18 |
| ndc | 68462-163-05 |
| ndc | 68462-163-10 |
| ndc | 68462-164-60 |
| ndc | 68462-164-01 |
| ndc | 68462-164-18 |
| ndc | 68462-164-05 |
| ndc | 68462-164-10 |
| ndc | 68462-165-60 |
| ndc | 68462-165-01 |
| ndc | 68462-165-18 |
| ndc | 68462-165-05 |
| ndc | 68462-165-10 |
| code_info | Lot #: 17241257, 17241258, 17241279, Exp. Date 06/2026 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0587-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.