Direct Rx recalls DULOXETINE D/R, a) 30 mg (NDC 61919-482-30), 30 Caps; b) 30 mg (NDC 61919-482-60), 60 Caps; CYMBALTA, Packaged and Distr

Recalled July 1, 2026 · FDA recall D-0617-2026 · Direct Rx

Hazard

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit · FDA Class II

Units

263 Bottles

Sold at

U.S. Nationwide

Description

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

Product

DULOXETINE D/R, a) 30 mg (NDC 61919-482-30), 30 Caps; b) 30 mg (NDC 61919-482-60), 60 Caps; CYMBALTA, Packaged and Distributed by Direct Rx.

Manufacturer(s)

Direct Rx

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