The U.S. Food and Drug Administration has initiated a voluntary recall of approximately 370,000 bottles of duloxetine delayed-release capsules—a common antidepressant medication used by millions—due to elevated levels of N-nitroso-duloxetine, classified as a probable human carcinogen. The affected products, manufactured by Towa Pharmaceutical and distributed in the United States through Breckenridge Pharmaceutical, include both 30mg and 60mg dosages.

The recall, designated Class II by the FDA, indicates that exposure to the product may cause temporary or medically reversible health effects. Nitrosamines—a family of compounds linked to cancer risks—were found exceeding federal safety limits in specific batches. Patients prescribed duloxetine are advised not to discontinue their medication abruptly without consulting a healthcare provider, as sudden cessation can trigger withdrawal symptoms.

The recalled lots include NDC 51991-747-10 (30mg, expiring April 2027) and NDC 51991-748-90 or 51991-748-10 (60mg). Affected lot codes are 241180C, 241074C, 240317, 240318, 240315C, 240373C, 240370C, 240375C, 240413C, 240316, 232311, and 240978C. Nitrosamines can form during manufacturing through chemical reactions with ingredients or environmental exposure over time, posing risks similar to those observed in past recalls of blood pressure medications and heartburn drugs.