FDA recall D-0419-2026

Product

Prazosin Hydrochloride Capsules, USP, 1mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ, Manufactured by: Appco Pharma LLC, Piscataway, NJ, NDC 70377-066-11.

Reason for recall

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

Distribution

U.S.A. Nationwide

Key facts

Status

Ongoing

Initiation date

2026-03-27

Report date

2026-04-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Piscataway, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0419-2026