FDA recall D-0617-2026

Direct Rx · Class II · drug

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.

Reason for recall

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

Distribution

U.S. Nationwide

Key facts

Status
Ongoing
Initiation date
2026-06-22
Report date
2026-07-01
Voluntary/Mandated
Voluntary: Firm initiated
Location
Dawsonville, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0617-2026