FDA Drug recall D-0216-2025
Carvedilol Tablets, USP, 12.5 mg, Rx only, a)500 Tablets, NDC 68462-164-05
- FDA Drug
- Class II
- ongoing
- Published 2025-02-12
On 2025-02-12 the FDA classified a Class II recall of Carvedilol Tablets, USP, 12.5 mg, Rx only, a)500 Tablets, NDC 68462-164-05 by Glenmark Pharmaceuticals Usa, citing CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0216-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-01-22 |
| Published | 2025-02-12 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Glenmark Pharmaceuticals Usa |
| Distribution | US |
Product
Carvedilol Tablets, USP, 12.5 mg, Rx only, a)500 Tablets, NDC 68462-164-05; b) 100 Tablets, NDC 68462-164-01, Manufactured for Glenmark Pharmaceuticals, NJ.
Reason
CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.
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 numbers: a) 17230658, Exp.: 02/2025; 17230814,17230822, Exp.: 03/2025; 17231004,17231009,17231022, Exp.: 04/2025; 1…Lot numbers: a) 17230658, Exp.: 02/2025; 17230814,17230822, Exp.: 03/2025; 17231004,17231009,17231022, Exp.: 04/2025; 17231393,17231392, Exp.: 05/2025; 17231538, 17231541,17231542, Exp.: 06/2025; 17231710,17231718,17231721,17231722,17231730, Exp': 07/2025; 17232169, Exp.: 09/2025; 17232253, Exp.: 10/2025; 17240220,17240240, Exp.: 01/2026; 17240459, Exp.: 02/2026 b) 17230814, Exp.: 03/2025; 17231392, Exp.:05/2025; 17232260, Exp.: 10/2025. |
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-0216-2025%22
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