Reported Nov 5, 2025 · Ongoing
Prazosin Hydrochloride, Capsules, USP, 2 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, 2 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, a) 100 Capsules, NDC 0093-4068-01, b) 1000 Capsules, NDC 0093-4068-10
- Lot codes and dates
12 of 12 products
Products covered by this recall # Product as published 1 Lot # 3010398A, 3010399A, 3010400A, 3010401A, 3010353A, Exp Date: 12/2025 2 Lot # 3010439A, 3010388A, Exp Date: 01/2026 3 Lot # 3010526A, 3010527A, Exp Date: 03/2026 4 Lot # 3010591A, 07/2026 5 Lot # 3010343A, Exp Date: 10/2025 6 Lot # 3010352A, Exp Date: 11/2025 7 Lot # 3010468A, 3010469A, 3010461A, Exp Date: 02/2026 8 Lot # 3010629A, Exp Date: 09/2026 9 Lot # 3010653A, Exp Date: 01/2027 10 Lot # 3010654A, 3010679A, 3010702A, Exp Date: 02/2027 11 Lot # 3010547A, Exp Date: 04/2026 b) NDC 0093-4068-10: Lot # 3010402A Exp Date: 02/2028 12 Lot # 3010593A, Exp Date: 07/2026, Lot # 3010610A, Exp Date: 09/2026 - Amount recalled
- 291,512 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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