Class IIOngoing

Prazosin Hydrochloride recall

FDA recall D-0104-2026 · initiated Oct 7, 2025

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

Why it was recalled

CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots.

Details

Product: Prazosin Hydrochloride, Capsules, USP, 1 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, a) 100 Capsules, NDC 0093-4067-01, b) 1000 Capsules, NDC 0093-4067-10
Recalling company: Teva Pharmaceuticals USA, Inc.
Classification: Class II
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: U.S. Nationwide
Initiated: Oct 7, 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-0104-2026 ↗

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