In a significant development affecting countless patients, the U.S. Food and Drug Administration (FDA) has issued a recall for certain batches of Duloxetine, a widely prescribed antidepressant, due to the presence of a potentially cancer-causing impurity. This action underscores growing concerns about nitrosamine contaminants in pharmaceuticals.

What Is Duloxetine?
Duloxetine, known by brand names such as Cymbalta, Drizalma Sprinkle, and Irenka, is a serotonin-norepinephrine reuptake inhibitor (SNRI) commonly prescribed to treat major depressive disorder, generalized anxiety disorder, fibromyalgia, diabetic neuropathy, and chronic musculoskeletal pain. Its dual-action mechanism enhances the levels of serotonin and norepinephrine in the brain, helping to alleviate both emotional and physical symptoms.

The Recall Details
The recall, initiated by Towa Pharmaceutical Europe, pertains to specific lots of delayed-release Duloxetine capsules found to contain N-nitroso-duloxetine, a nitrosamine impurity.