FDAOctober 16, 2025drug

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Ongoing

Brands named

amerisource health servicesamerisourceamerisource health

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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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 — Recall Details · AllClear