Drug recall D-0103-2026

Class II Ongoing reported Nov 5, 2025

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 for recall

Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit

Lots and codes

Lot #: 1016996, 1018336, 1021220, Exp. Date 11/30/2025; 1022421, 1025017, Exp. Date 08/31/2026.

Recall details

Recalling firm
Amerisource Health Services LLC, Columbus, OH
Quantity
3,410 cartons
Distribution
Nationwide within the United States
Type
Voluntary: Firm initiated
Recall initiated
October 16, 2025

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