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
This recall is currently active, issued November 5, 2025. It was issued by Teva Pharmaceuticals Usa, Inc.
- Company
- Teva Pharmaceuticals Usa, Inc
- Recall Initiated
- October 7, 2025
- Posted
- November 5, 2025
- Recall Number
- D-0105-2026
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 291,512 bottles
- Firm Location
- Parsippany, NJ, United States
- Official Source
- View on FDA website ↗
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.
Distribution
U.S. Nationwide
Lot / Code Info
a) NDC 0093-4068-01: Lot # 3010398A, 3010399A, 3010400A, 3010401A, 3010353A, Exp Date: 12/2025; Lot # 3010439A, 3010388A, Exp Date: 01/2026; Lot # 3010526A, 3010527A, Exp Date: 03/2026; Lot # 3010591A, 07/2026; Lot # 3010343A, Exp Date: 10/2025; Lot # 3010352A, Exp Date: 11/2025; Lot # 3010468A, 3010469A, 3010461A, Exp Date: 02/2026; Lot # 3010629A, Exp Date: 09/2026; Lot # 3010653A, Exp Date: 01/2027; Lot # 3010654A, 3010679A, 3010702A, Exp Date: 02/2027; Lot # 3010547A, Exp Date: 04/2026 b) NDC 0093-4068-10: Lot # 3010402A Exp Date: 02/2028; Lot # 3010593A, Exp Date: 07/2026, Lot # 3010610A, Exp Date: 09/2026