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

Recalled April 8, 2026 · FDA recall D-0421-2026 · Appco Pharma

Hazard

cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits. · FDA Class II

Units

28,157 bottles- 100's count

Sold at

U.S.A. Nationwide

Description

cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.

Product

Prazosin Hydrochloride Capsules, USP, 5mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ, Manufactured by: Appco Pharma LLC, Piscataway, NJ, NDC 70377-068-11.

Manufacturer(s)

Appco Pharma LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →