Rising Pharmaceuticals has initiated a nationwide recall of 7,107 bottles of duloxetine after discovering contamination with N-nitroso-duloxetine, a chemical compound linked to cancer risks. The recall, classified as Class II by the FDA on November 19, 2024, affects 20 mg capsules of the widely prescribed antidepressant. The FDA explains that N-nitroso-duloxetine can form during manufacturing, storage, or packaging processes. “FDA, in collaboration with regulatory counterparts around the world, has set internationally recognized acceptable daily intake limits for nitrosamines. Nitrosamines below this level are acceptable in drugs. If drugs contain levels of nitrosamines above the acceptable daily intake limit, the FDA … Continue reading FDA Recalls 7,107 Duloxetine Bottles Due to Cancer-Linked N-Nitroso Contamination Risk