Nearly 375000 bottles of antidepressant duloxetine recalled over cancer-causing contamination

17 June 2026 · Source balance: Centre

A popular antidepressant medication called duloxetine, also known by the brand name Cymbalta, has been recalled nationwide. Nearly 375,000 bottles were pulled from shelves after tests revealed elevated levels of a chemical impurity called N-nitroso-duloxetine. This chemical belongs to a group of compounds known as nitrosamines, which scientists classify as probable human carcinogens. The FDA classified this as a Class II recall, meaning the probability of serious harm is considered remote. The medication manufacturer Towa Pharmaceutical and distributor Breckenridge Pharmaceuticals issued the voluntary recall after detecting levels exceeding federal safety limits. The FDA notes that exposure at or below acceptable daily intake limits is not expected to increase cancer risk. This is the second major duloxetine recall by Breckenridge in less than two years. Patients are advised to consult healthcare providers before discontinuing the medication, as abruptly stopping antidepressants can cause withdrawal symptoms.