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.
Agency: FDA
Recall date: 2026-06-22
Recalling firm: Direct Rx

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

Hazard: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Severity: Class II
Distribution: U.S. Nationwide