The FDA has flagged a nationwide recall involving nearly 375,000 bottles of duloxetine delayed-release capsules after testing identified elevated levels of a potentially cancer-causing impurity. The affected products were distributed by Breckenridge Pharmaceuticals and manufactured by Towa Pharmaceutical Europe in Spain.
Duloxetine is a prescription medication used to treat conditions including depression, anxiety disorder, fibromyalgia, and diabetic nerve pain. The recalled products were voluntarily withdrawn by the company, and the FDA later classified the recalls as Class II events, indicating a risk of temporary or medically reversible adverse health consequences.
FDA Identifies Nitrosamine Impurity in Recalled Medication
According to FDA recall notifications published on June 4, two separate recalls were initiated because of the presence of N-nitroso-duloxetine impurity above the agency’s recommended interim limit.
The first recall involves 14,729 bottles of Duloxetine Delayed-Release Capsules, USP, 30 mg, packaged in 1,000-capsule bottles. The affected lot is 241180C, with an expiration date of April 2027. The FDA assigned this action recall number D-0582-2026.
A second recall covers 359,676 bottles of Duloxetine Delayed-Release Capsules, USP, 60 mg, packaged in both 90-capsule and 1,000-capsule containers. According to the FDA, the affected lots include 241074C; 240317; 240318; 240315C; 240373C; 240370C; 240375C; 240413C; 240316; 232311; 240978C; and 241052C, with expiration dates ranging from November 2026 through May 2027.
Together, the two recalls affect approximately 374,405 bottles distributed nationwide within the United States. Both recalls were initiated voluntarily by Breckenridge Pharmaceutical, Inc. on June 4, 2026, and received FDA Class II classification on June 8. The recalls remain ongoing.
The FDA identified the reason for both actions as a current good manufacturing practice (CGMP) deviation involving levels of N-nitroso-duloxetine that exceeded the agency’s recommended interim threshold.
What Patients and Regulators Are Saying
According to information reported by NBC and reflected in FDA enforcement records, duloxetine is the generic equivalent of several branded medications, including Cymbalta. It is commonly prescribed for depression, anxiety, and fibromyalgia.
Health authorities note that nitrosamines can form during the manufacturing, storage, or packaging of certain medications. The FDA states that these compounds are also present in water and foods and that people are commonly exposed to them at low levels.
The agency has said that exposure to nitrosamine impurities above acceptable limits over extended periods may increase the risk of cancer. The recall notifications do not report immediate severe health effects linked to the affected lots, a factor reflected in the FDA’s Class II designation.
According to NBC’s report, patients who possess recalled duloxetine products are advised to contact their physician or pharmacist regarding appropriate next steps. Officials also advised patients not to stop taking prescribed medication without first consulting a healthcare professional.
The latest action follows an earlier duloxetine recall reported in 2024 involving more than 7,000 bottles that were also withdrawn because of N-nitroso-duloxetine impurity concerns. For now, the FDA’s notices focus on the specific lots identified in the ongoing nationwide recall.
