FDA recalls duloxetine bottles after tests found elevated levels of possible cancer-causing impurity.
Hundreds of thousands of bottles of a commonly prescribed antidepressant are being pulled from pharmacies across the U.S. after testing found amounts of a chemical impurity above federal safety limits. The recall involves duloxetine delayed-release capsules, the generic version of Cymbalta. The medicine is prescribed to treat depression and anxiety and is also used for certain long-lasting pain conditions, including nerve pain and fibromyalgia. Officials said nearly 375,000 bottles are part of the antidepressant recall.
According to the U.S. Food and Drug Administration (FDA), tests found elevated levels of N-nitroso-duloxetine in some capsules. The substance belongs to a group of chemicals called nitrosamines, which have been linked to cancer in animal studies and are considered probable cancer-causing compounds in humans when exposure remains above accepted limits for long periods. The recalled medicine was made by Towa Pharmaceutical at a manufacturing facility in Spain and distributed throughout the U.S. by Breckenridge Pharmaceutical Inc. Both 30-milligram and 60-milligram capsule strengths are included in the recall.
The FDA classified the action as a Class II recall. This category means the product may cause temporary health problems or medically reversible effects, though the chance of severe harm is considered lower than in the agency’s highest recall category. At this time, federal officials said there have been no reports of illnesses or other harmful reactions tied to the recalled medication. Even so, health experts are encouraging patients to check their prescriptions and speak with a healthcare provider if their medication is part of the antidepressant recall.
Medical professionals stress that patients should not suddenly stop taking duloxetine on their own. The medication affects brain chemicals involved in mood and pain and stopping it abruptly can cause uncomfortable withdrawal symptoms. People who discontinue the drug too quickly may experience dizziness, nausea, headaches, sleep problems, irritability or unusual sensations described as electric shocks. Doctors generally recommend reducing the medicine slowly under medical supervision when treatment needs to end or change. Patients with questions about their prescriptions are encouraged to contact their doctor or pharmacist.
Pharmacies, clinics and healthcare facilities have also been advised to review their inventories for affected products. The FDA has instructed distributors and healthcare providers to follow the antidepressant recall procedures for returning or disposing of the capsules.
Concerns over nitrosamines have led to several drug recalls during the past few years. The compounds can form during manufacturing, packaging or storage under certain conditions. Federal regulators have stepped up testing and oversight of medications after traces of nitrosamines were found in several widely used drugs, including blood pressure medicines, diabetes treatments and heartburn products. Duloxetine itself has faced similar problems before. In 2024, thousands of bottles were recalled after tests detected nitrosamine levels above recommended limits. The latest action is far larger and affects products shipped across the country.
Mental health specialists note that duloxetine remains an important medicine for many patients. Millions of prescriptions are written every year because the drug can help relieve symptoms of depression, anxiety and chronic pain that interfere with daily life. The recall does not apply to every bottle of duloxetine on the market, only those linked to the affected manufacturing lots. For now, patients are being advised to check lot numbers carefully.
Sources:
Antidepressant recalled due to potentially cancer-causing impurity
Popular antidepressant recalled in US over cancer-causing substance fears: FDA
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