Class II
Drug Recall: 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.
Appco Pharma LLC · March 27, 2026
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
States Affected
NATIONWIDE
Quantity Affected
88,008 bottles- 100's count
Source: FDA (openFDA Drug Enforcement)
Recall number: D-0419-2026
Status: ongoing
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