Reported Nov 5, 2025 · Ongoing
Prazosin Hydrochloride, Capsules, USP, 5 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?
3 of 3 products
| # | Product as published |
|---|---|
| 1 | 100 Capsules, NDC 0093-4069-01 |
| 2 | 250 Capsules, NDC 0093-4069-52 |
| 3 | 500 Capsules, NDC 0093-4069-05 |
- Lot codes and dates
7 of 7 products
Products covered by this recall # Product as published 1 Lot # 3010403A, 3010385A, 3010404A, Exp Date: 02/2026 2 Lot # 3010405A, 3010510A, 3010528A, 3010354A, Exp Date: 03/2026 3 Lot # 3010592A, 3010605A, 3010611A, 3010612A, Exp Date: 08/2026 4 Lot # 3010655A, 3010703A, Exp Date: 02/2027 b) NDC 0093-4069-52 5 Lot # 3010430A, Exp Date: 11/2025 6 Lot # 3010613A, Exp Date: 08/2026 c) NDC 0093-4069-05 7 Lot # 3010406A, Exp Date: 02/2026 - Amount recalled
- 107,673
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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