Recall: D-0101-2026

Class II - Potentially Harmful

Class IIClassification

2025-10-16Initiated

OngoingStatus

Amerisource Health Services LLFirm

Product

Prazosin 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 68084-996-11

Reason

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

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.