Prazosin Hydrochloride, Capsules, USP, 1 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, IN...
FDA Recall #D-0104-2026 — Class II — October 7, 2025
Product Description
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.
Recalling Firm
Teva Pharmaceuticals USA, Inc — Parsippany, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
181,659 bottles
Distribution
U.S. Nationwide
Code Information
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
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated