FDAHealthOctober 16, 2025

Amerisource Health Services LLC — Prazosin Hydrochloride, Capsules, USP, 5 mg, 20 capsules (5x4) cartons, Rx only, Distributed by American Health Packaging, Columbus, Ohio 43217, carton NDC 60687-572-

⚠️ 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, 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
Brand: PRAZOSIN HYDROCHLORIDE
Lot code: 1016996

Additional details

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

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 3,410 cartons.

View original FDA notice →

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