Class IIOngoing

Prazosin Hydrochloride recall

FDA recall D-0101-2026 · initiated Oct 16, 2025

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

Why it was recalled

Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit

Details

Product: Prazosin Hydrochloride, Capsules, USP, 1 mg, 100 capsules (10x10) cartons, Rx only, Distributed by American Health Packaging, Columbus, Ohio 43217, Carton NDC 68084-996-01. Individual unit dose: NDC 68084-996-11
Recalling company: Amerisource Health Services LLC
Classification: Class II
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: Nationwide within the United States
Initiated: Oct 16, 2025
FDA report date: Nov 5, 2025

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-0101-2026 ↗

← All drug recalls