Drug recall D-0106-2026
Product
Prazosin Hydrochloride, Capsules, USP, 5 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, a) 100 Capsules, NDC 0093-4069-01, b) 250 Capsules, NDC 0093-4069-52, c) 500 Capsules, NDC 0093-4069-05
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 0093-4069-01: Lot # 3010403A, 3010385A, 3010404A, Exp Date: 02/2026; Lot # 3010405A, 3010510A, 3010528A, 3010354A, Exp Date: 03/2026; Lot # 3010592A, 3010605A, 3010611A, 3010612A, Exp Date: 08/2026; Lot # 3010655A, 3010703A, Exp Date: 02/2027 b) NDC 0093-4069-52: Lot # 3010430A, Exp Date: 11/2025, Lot # 3010613A, Exp Date: 08/2026 c) NDC 0093-4069-05: Lot # 3010406A, Exp Date: 02/2026
Recall details
- Recalling firm
- Teva Pharmaceuticals USA, Inc, Parsippany, NJ
- Quantity
- 107,673
- 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.