WhichRecall
Class IIReported 2025-11-05

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

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-0102-2026
Classification
Class II
Status
Ongoing
Category
drug
Initiated
2025-10-16
Reported
2025-11-05
Distribution
Nationwide within the United States
Code Info
Lot #: 1020109, Exp. Date 02/28/2026; 1024343, 1025355, Exp. Date 09/30/2026.
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.
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