FDA Recalls Over 350,000 Bottles of Antidepressant Duloxetine Due to Potential Carcinogen

The U.S. Food and Drug Administration (FDA) has announced the recall of more than 350,000 bottles of duloxetine delayed-release capsules, a generic form of the antidepressant Cymbalta. The recall, initiated by Breckenridge Pharmaceutical, Inc., is due to the presence of N-nitroso-duloxetine, a nitrosamine impurity, at levels exceeding the FDA's acceptable daily intake limit. Nitrosamines are classified as probable human carcinogens, and long-term exposure above acceptable thresholds may increase cancer risk. Patients are advised not to stop taking duloxetine suddenly and to contact their healthcare provider first.