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Recall Observatory FDA recall evidence

Drug product

Prazosin Hydrochloride, Capsules, USP, 5 mg, 20 capsules (5x4) cartons, Rx only, Distributed by American Health Packaging, Columbus, Ohio 43217, carton NDC 60687-572-32, Individual unit dose: NDC 60687-572-33

D-0103-2026

October 16, 2025

Class II

Product summary

Firm
Amerisource Health Services LLC
Event
Event 97826
Status
Ongoing
Classification
Class II
Quantity
3,410 cartons
Official record key
drug-enforcement:D-0103-2026

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 #: 1016996, 1018336, 1021220, Exp. Date 11/30/2025; 1022421, 1025017, Exp. Date 08/31/2026.

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