CARVEDILOL

Generic: CARVEDILOL

Aurobindo Pharma LimitedManufacturer

ORALRoute

CARVEDILOLActive Substance

2007-09-05Original Approval

CARVEDILOL is FDA application ANDA078332, sponsored by AUROBINDO PHARMA. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.

Recalls

Class II2025-02-28

Carvedilol Tablets USP 25 mg, 500 -Count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured f

CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake

Class II2025-02-28

Carvedilol Tablets USP 12.5 mg, 500-Count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured

CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake

Class II2025-08-07

Carvedilol Tablets, USP, 12.5 mg, 500-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd, Colvale-Bard

CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acce

Class II2025-01-22

Carvedilol Tablets, USP, 12.5 mg, Rx only, a)500 Tablets, NDC 68462-164-05; b) 100 Tablets, NDC 68462-164-01, Manufactur

CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA re

Class II2025-01-22

Carvedilol Tablets, USP, 25 mg, Rx only, a)500 Tablets, NDC 68462-165-05; b) 100 Tablets, NDC 68462-165-01, Manufactured

CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA re

Class II2025-02-28

Carvedilol Tablets USP 3.125mg Tablets a.)100-count bottle (NDC 68462-162-01), b.) 500-count bottle (NDC 68462-162-05),

CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake

Class II2025-08-06

Carvedilol Tablets, USP, 25 mg, 500 Tablets per carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No

CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above th

Class II2025-02-28

Carvedilol Tablets USP 6.25 mg, a.)100-count bottle (NDC 68462-163-01), b.) 500-count bottle (NDC 68462-163-05) Rx Only,

CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake

Class II2025-08-06

Carvedilol Tablets, USP, 12.5 mg, 500 Tablets per carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot

CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above th

Class II2025-03-13

Carvedilol Tablets, USP 12.5 mg, 500-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur

CARVEDILOL

Recalls

Top Reported Reactions