Prazosin Hydrochloride Capsules recalled over manufacturing violations

Recall date

March 27, 2026

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

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

Recall number

D-0421-2026

FDA classification

Class II

Brand / firm

Appco Pharma LLC

Sold / distributed

U.S.A. Nationwide

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.