Antidepressant recalled over potential cancer-causing substance

A popular antidepressant is being recalled because it may contain elevated levels of a cancer-causing substance, the FDA reports. Breckenridge Pharmaceutical, Inc. voluntarily recalls nearly 370,000 bottles of Duloxetine delayed-release capsules, manufactured by Towa Pharmaceutical Europe in Spain and distributed in the U.S. The impurity, N-nitroso-duloxetine, belongs to nitrosamines, a class of probable human carcinogens. While no adverse effects have been reported, the FDA classifies the recall as Class II, indicating potential temporary health effects with exposure. The recall involves multiple bottle sizes and lot codes; commenters from the manufacturers were not immediately available. A similar recall occurred in 2024, affecting thousands more bottles.