FDA Drug recall D-0578-2025
Carvedilol Tablets, USP, 12.5 mg, 500-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd, Colvale-Bardez, Goa, 403513, In…
- 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-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd, Colvale-Bardez, Goa, 403513, In… by Glenmark Pharmaceuticals Usa, citing CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0578-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-08-07 |
| 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-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd, Colvale-Bardez, Goa, 403513, India. Manufactured for Glenmark Pharmaceuticals, Inc., USA, Mahwah, NJ 07430. NDC 68462-164-05
Reason
CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
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#:19243202, Exp: 7/31/2026. |
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-0578-2025%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.