PRAZOSIN HYDROCHLORIDE

Generic: PRAZOSIN HYDROCHLORIDE

Prasco LaboratoriesManufacturer

ORALRoute

PRAZOSIN HYDROCHLORIDEActive Substance

1976-06-23Original Approval

PRAZOSIN HYDROCHLORIDE is FDA application NDA017442, sponsored by PFIZER. 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 II2026-03-27

Prazosin Hydrochloride Capsules, USP, 1mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ,

cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impur

Class II2025-10-07

Prazosin Hydrochloride, Capsules, USP, 2 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 194

CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Poten

Class II2026-03-27

Prazosin Hydrochloride Capsules, USP, 2mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ,

cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impur

Class II2025-10-07

Prazosin Hydrochloride, Capsules, USP, 1 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 194

CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Poten

Class II2025-10-16

Prazosin Hydrochloride, Capsules, USP, 5 mg, 20 capsules (5x4) cartons, Rx only, Distributed by American Health Packagin

Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Car

Class II2025-10-16

Prazosin Hydrochloride, Capsules, USP, 2 mg, 100 capsules (10x10) cartons, Rx only, Distributed by American Health Packa

Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Car

Class II2026-03-27

Prazosin Hydrochloride Capsules, USP, 5mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ,

cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impur

Class II2025-10-16

Prazosin Hydrochloride, Capsules, USP, 1 mg, 100 capsules (10x10) cartons, Rx only, Distributed by American Health Packa

Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Car

Class II2022-04-13

Prazosin Hydrochloride Capsules, USP, 1 mg, 100-count bottle, Rx only, MFG: Mylan Pharma, NDC 0378-1101-01

cGMP deviations: Temperature abuse

Class II2025-10-07

Prazosin Hydrochloride, Capsules, USP, 5 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 194

CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Poten

PRAZOSIN HYDROCHLORIDE

Recalls

Top Reported Reactions