United StatesPrazosin Hydrochloride capsules (USP) 1 mg (100 capsules, carton NDC 68084-996-01; unit dose NDC 68084-996-11), 2 mg (100 capsules, carton NDC 68084-997-01; unit dose NDC 68084-997-11), and 5 mg (20 capsules, carton NDC 60687-572-32; unit dose NDC 60687-572-33) distributed by American Health Packaging, Columbus, OH, in specified lots with expirations ranging 02/28/2026–11/30/2025–09/30/2026 are affected. They were recalled because they failed impurities/degradation specifications due to N-nitroso Prazosin impurity C above the CPCA acceptable intake limit; the recall is nationwide in the United States.
What's being recalled
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
Prazosin Hydrochloride, Capsules, USP, 2 mg, 100 capsules (10x10) cartons, Rx only, Distributed by American Health Packaging, Columbus, Ohio 43217, Carton NDC 68084-997-01, Individual unit dose: NDC 68084-997-11
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
Recalling firm: Amerisource Health Services LLC, Columbus, OH, United States.
How to identify it
Lot #: 1023526, 1023555, Expiry: 07/31/2026 Lot #: 1020109, Exp. Date 02/28/2026; 1024343, 1025355, Exp. Date 09/30/2026. Lot #: 1016996, 1018336, 1021220, Exp. Date 11/30/2025; 1022421, 1025017, Exp. Date 08/31/2026.
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
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Nationwide within the United States
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)