WhichRecall
Class IIReported 2025-11-05

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

Recalled by Amerisource Health Services LLC

Reason for Recall

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

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Recall Number
D-0103-2026
Classification
Class II
Status
Ongoing
Category
drug
Initiated
2025-10-16
Reported
2025-11-05
Distribution
Nationwide within the United States
Code Info
Lot #: 1016996, 1018336, 1021220, Exp. Date 11/30/2025; 1022421, 1025017, Exp. Date 08/31/2026.
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.
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