Prazosin Hydrochloride, Capsules, USP, 1 mg, 100 capsules (10x10) cartons, Rx only, Distributed b...
FDA Recall #D-0101-2026 — Class II — October 16, 2025
Product Description
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 for Recall
Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit
Recalling Firm
Amerisource Health Services LLC — Columbus, OH
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
1,970 cartons
Distribution
Nationwide within the United States
Code Information
Lot #: 1023526, 1023555, Expiry: 07/31/2026
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated