D-0101-2026 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- November 5, 2025
- Initiation Date
- October 16, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,970 cartons
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
Distribution Pattern
Nationwide within the United States
Code Information
Lot #: 1023526, 1023555, Expiry: 07/31/2026