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  3. Recall Enforcement Event ID: 97826

Recall Enforment Report D-0102-2026

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Amerisource Health Services LLC, originally initiated on 10-16-2025 for the product 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 The product was recalled due to failed impurities/degradation specification: presence of n-nitroso prazosin impurity c above the carcinogenic potency categorization approach (cpca) acceptable intake limit. The product was distributed nationwide and the recall is currently ongoing.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0102-202610-16-202511-05-2025Class II1,818 cartonsPrazosin 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 68084-997-11Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limitOngoing
D-0101-202610-16-202511-05-2025Class II1,970 cartonsPrazosin Hydrochloride, Capsules, USP, 1 mg, 100 capsules (10x10) cartons, Rx only, Distributed by American Health Packaging, Columbus, Ohio 43217, Carton NDC 68084-996-01. Individual unit dose: NDC 68084-996-11Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limitOngoing
D-0103-202610-16-202511-05-2025Class II3,410 cartonsPrazosin 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 60687-572-33Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limitOngoing

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
60687-572Prazosin Hydrochloride Prazosin HydrochlorideCapsuleOralAmerican Health PackagingHuman Prescription Drug
68084-996Prazosin Hydrochloride Prazosin HydrochlorideCapsuleOralAmerican Health PackagingHuman Prescription Drug
68084-997Prazosin Hydrochloride Prazosin HydrochlorideCapsuleOralAmerican Health PackagingHuman Prescription Drug