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CLASS II · ModerateFDA

Amerisource Health Services LLC recalls Prazosin Hydrochloride

📅 Oct 16, 2025 · 📍 Nationwide
Recalling company
Amerisource Health Services LLC
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
Reason
Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Oct 16, 2025
Reported
Nov 5, 2025
Distribution
Nationwide within the United States
Status
Ongoing
Quantity
1,970 cartons
Lot / codes
Lot #: 1023526, 1023555, Expiry: 07/31/2026
Company location
Columbus, OH
Recall type
Voluntary: Firm initiated
Recall number
D-0101-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number D-0101-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.