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Prazosin Hydrochloride Capsules 1mg
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DRUG RECALLMODERATE

Prazosin Hydrochloride Capsules 1mg

Appco Pharma is recalling Prazosin Hydrochloride 1mg capsules due to the presence of N-nitroso-prazosin (NNP) impurity above acceptable limits.

What to do

Consult your healthcare provider or pharmacist regarding this medication. Do not stop taking your medication without first consulting a medical professional.

Posted
Updated
Recall No.
D-0419-2026
Agency
Firm
Appco Pharma LLC
Recall ID
98658
Status
ONGOING

Why it was recalled

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

How to identify it

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.

Where it was sold

Distributed in US.

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Editorial summary by Recall Canary · last updated 2026-06-05 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification