Drug 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

D-0101-2026

October 16, 2025

Class II

Product summary

Firm: Amerisource Health Services LLC
Event: Event 97826
Status: Ongoing
Classification: Class II
Quantity: 1,970 cartons
Official record key: drug-enforcement:D-0101-2026

Official wording

Reason: Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit

Code information: Lot #: 1023526, 1023555, Expiry: 07/31/2026

Distribution pattern: Nationwide within the United States

Derived failure modes

Foreign material or chemical contamination
reason.foreign_material_chemical_contamination · v1.0.0

Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the
Potency or specification failure
reason.potency_specification_failure · v1.0.0

Failed Impurities/Degradation Specification