Class IIOngoing

Prazosin Hydrochloride Capsules recall

FDA recall D-0421-2026 · initiated Mar 27, 2026

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

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

Details

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.
Recalling company: Appco
Classification: Class II
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: U.S.A. Nationwide
Initiated: Mar 27, 2026
FDA report date: Apr 8, 2026

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0421-2026 ↗

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