FDAHealthOctober 16, 2025

Amerisource Health Services LLC — Prazosin Hydrochloride, Capsules, USP, 1 mg, 100 capsules (10x10) cartons, Rx only, Distributed by American Health Packaging, Columbus, Ohio 43217, Carton NDC 68084-9

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

Is this relevant to me?

Geography: Nationwide
Source agency: FDA
Category: Health
Published: October 16, 2025

Nationwide within the United States

What's affected?

Product: 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
Brand: PRAZOSIN HYDROCHLORIDE
Lot code: 1023526

Additional details

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

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 1,970 cartons.

View original FDA notice →

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