US Drug Recall Register
Class II · Moderate risk Ongoing Initiated Oct 16, 2025 (11 months ago)

Prazosin Hydrochloride

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

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

What was recalled

Prazosin Hydrochloride, Capsules, USP, 2 mg, 100 capsules (10x10) cartons, Rx only, Distributed by American Health Packaging, Columbus, Ohio 43217, Carton NDC 68084-997-01, Individual unit dose: NDC 68084-997-11

Recalling firm
Amerisource Health Services LLC
NDC code
68084-997-01
Origin
OH, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0102-2026

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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