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Class II

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

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

Recall number
D-0101-2026
Report date
November 5, 2025
Classification
Class II
Status in dataset
Ongoing
Recalling firm
Amerisource Health Services LLC
Generic names
PRAZOSIN HYDROCHLORIDE
Brand names
PRAZOSIN HYDROCHLORIDE
Product NDCs
68084-996, 68084-997

Code and lot information

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

Distribution

Nationwide within the United States

Do not stop or change a prescribed medication based only on this page.Contact your pharmacist or prescriber and compare the exact product, manufacturer, NDC, and lot information.

Source and limitations

This page reflects a public openFDA Drug Enforcement record. The dataset was last checked on September 23, 2026. openFDA states that enforcement data should not be used alone to issue public alerts or track the full lifecycle of a recall.

Review the official FDA Drug Recalls page and the underlying openFDA query.