Class II
Ongoing
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
This recall is currently active, issued November 5, 2025. It was issued by Amerisource Health Services Llc.
- Company
- Amerisource Health Services Llc
- Recall Initiated
- October 16, 2025
- Posted
- November 5, 2025
- Recall Number
- D-0102-2026
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 1,818 cartons
- Firm Location
- Columbus, OH, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit
Distribution
Nationwide within the United States
Lot / Code Info
Lot #: 1020109, Exp. Date 02/28/2026; 1024343, 1025355, Exp. Date 09/30/2026.
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