Skip to content
Recall Observatory FDA recall evidence

Drug 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

D-0102-2026

October 16, 2025

Class II

Product summary

Firm
Amerisource Health Services LLC
Event
Event 97826
Status
Ongoing
Classification
Class II
Quantity
1,818 cartons
Official record key
drug-enforcement:D-0102-2026

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 #: 1020109, Exp. Date 02/28/2026; 1024343, 1025355, Exp. Date 09/30/2026.

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