Amerisource Health Services LLC recalls Prazosin Hydrochloride
- Recalling company
- Amerisource Health Services LLC
- Product
- Prazosin Hydrochloride, Capsules, USP, 5 mg, 20 capsules (5x4) cartons, Rx only, Distributed by American Health Packaging, Columbus, Ohio 43217, carton NDC 60687-572-32, Individual unit dose: NDC 60687-572-33
- 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
- 3,410 cartons
- Lot / codes
- Lot #: 1016996, 1018336, 1021220, Exp. Date 11/30/2025; 1022421, 1025017, Exp. Date 08/31/2026.
- Company location
- Columbus, OH
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0103-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0103-2026 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.