Duloxetine Capsules Recalled Due to Elevated Cancer-Causing Chemical Levels

Towa Pharmaceutical and its U.S. distributor, Breckenridge Pharmaceutical, have recalled nearly 370,000 bottles of duloxetine delayed-release capsules due to concerns over elevated levels of N-nitroso-duloxetine, a chemical that may cause cancer. The recall, initiated on June 4, affects both 30 mg and 60 mg capsules of duloxetine, a medication commonly prescribed for depression, anxiety, and chronic nerve pain. The Food and Drug Administration (FDA) has classified this as a Class II recall, indicating that exposure to the affected product could lead to temporary or medically reversible health consequences, although serious adverse effects are considered unlikely. The FDA has not disclosed the cause of the elevated nitrosamine levels, which can arise during manufacturing or from contaminated ingredients. Breckenridge has reported no adverse events linked to the recalled medication. Health officials emphasize that nitrosamines are commonly found in food and water, and long-term exposure above acceptable limits is primarily associated with cancer risks. Patients are advised to consult healthcare providers before discontinuing duloxetine, as abrupt cessation can lead to withdrawal symptoms.