Teva Pharmaceuticals USA, Inc recalls Prazosin Hydrochloride, Capsules, USP, 2 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 194

Recalled November 5, 2025 · FDA recall D-0105-2026 · Teva Pharmaceuticals USA

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. · FDA Class II

Units

291,512 bottles

Sold at

U.S. Nationwide

Description

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.

Product

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

Manufacturer(s)

Teva Pharmaceuticals USA, Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →