Reported Nov 5, 2025 · Ongoing
Prazosin Hydrochloride, Capsules, USP, 1 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA…
Teva Pharmaceuticals USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Teva Pharmaceuticals USA, Inc · 400 Interpace Pkwy Bldg A · Parsippany, NJ · 07054-1120
Is this the product you have?
- Prazosin Hydrochloride, Capsules, USP, 1 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, a) 100 Capsules, NDC 0093-4067-01, b) 1000 Capsules, NDC 0093-4067-10
- Lot codes and dates
7 of 7 products
Products covered by this recall # Product as published 1 Lot # 3010544A and 3010545A, Exp Date: 10/2025 2 Lot # 3010567A, Exp Date: 12/2025 3 Lot # 3010590A, Exp Date: 02/2026 4 Lot # 3010601A, 3010602A, 3010603A, Exp Date: 03/2026 5 Lot # 3010652A, 3010670A, 3010671A, Exp Date: 07/2026 6 Lot # 3010678A, 3010700A, 3010701A, Exp Date: 08/2026 b) NDC 0093-4067-10: Lot # 3010440A, Exp Date: 12/2025 7 Lot # 3010672A, Exp Date: 07/2026 - Amount recalled
- 181,659 bottles
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots.
This product could cause temporary or reversible health problems — stop using it.
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