Drug recall D-0104-2026
Product
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
Reason for recall
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.
Lots and codes
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
Recall details
- Recalling firm
- Teva Pharmaceuticals USA, Inc, Parsippany, NJ
- Quantity
- 181,659 bottles
- Distribution
- U.S. Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- October 7, 2025
Related products
- Prazosin Hydrochloride – drug information
- NDC 0093-4068 Prazosin Hydrochloride · Prazosin Hydrochloride 2 mg/1 · Teva Pharmaceuticals USA, Inc.
- NDC 0093-4067 Prazosin Hydrochloride · Prazosin Hydrochloride 1 mg/1 · Teva Pharmaceuticals USA, Inc.
- NDC 0093-4069 Prazosin Hydrochloride · Prazosin Hydrochloride 5 mg/1 · Teva Pharmaceuticals USA, Inc.