FDAFDA · Food and drugs·Recall number D-0104-2026
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
Published November 5, 2025 · Recall initiated: October 7, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- PRAZOSIN HYDROCHLORIDE
- Manufacturer
- Teva Pharmaceuticals USA, Inc
- Distributor
- U.S. Nationwide
- UPC
- 0300934068016
- Lot
- a) NDC 0093-4067-01: Lot # 3010544A and 3010545A, Exp Date: 10/2025; Lot # 3010567A, Exp Date: 12/2025; Lot # 3010590A, Exp Date: 02/2026; Lot # 3010601A, 3010602A, 3010603A, Exp Date: 03/2026; Lot # 3010652A, 3010670A, 3010671A, Exp Date: 07/2026; Lot # 3010678A, 3010700A, 3010701A, Exp Date: 08/2026 b) NDC 0093-4067-10: Lot # 3010440A, Exp Date: 12/2025; Lot # 3010672A, Exp Date: 07/2026
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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