Duloxetine Delayed-Release Capsules
Direct Rx is recalling 30 mg Duloxetine Delayed-Release capsules due to N-nitroso-duloxetine impurity levels exceeding FDA limits.
Contact your healthcare provider or pharmacist to discuss alternative treatment options. Do not stop taking your medication without consulting a medical professional.
Why it was recalled
Direct Rx is recalling specific lots of Duloxetine Delayed-Release capsules due to the presence of N-nitroso-duloxetine impurity exceeding the FDA recommended interim limit. This recall affects 30 mg strength capsules in 30-count and 60-count bottles.
Is mine affected?
Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.
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.
- Recall #
- D-0617-2026
Where it was sold
Distributed nationwide.
Official source
Editorial summary by Recall Canary · last updated 2026-06-24 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification