← FDA ENFORCEMENT
D-0101-2026Class II

Amerisource Health Services LLC

Recalling firm
Amerisource Health Services LLC
Product type
Drug
Status
Ongoing
Report date
2025-11-05
Distribution
Nationwide within the United States
Firm state
OH
Product quantity
1,970 cartons
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
Reason for recall

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

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

Code / lot info

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

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.