FDA Issues Class II Recall for Duloxetine Capsules Due to Nitrosamine Impurity

The US Food and Drug Administration (FDA) has announced a Class II recall of Duloxetine Delayed Release (D/R) 20 mg capsules in 30-count bottles. The affected product, labeled under NDC 61919-422-30, was packaged and distributed by Direct Rx and Breckenridge Pharmaceutical, Inc, based in Berlin, Connecticut. Only lot #02AU2406 is affected, with an expiration date of January 31, 2027. A total of 16 bottles were distributed nationwide.

This recall was initiated voluntarily by the manufacturer, Direct Rx, on March 7, 2025, following the detection of a nitrosamine drug substance-related impurity that exceeded the FDA's proposed interim limit. Nitrosamines are chemical compounds that may increase cancer risk with prolonged exposure. The FDA formally classified the recall as Class II on August 4, 2025, indicating that use of the product may cause temporary or medically reversible adverse health consequences, though the risk of serious harm is relatively remote. The company notified customers through an official letter, and the recall remains ongoing.

Duloxetine, marketed under various brand names including Cymbalta, is a prescription medication indicated for the treatment of major depressive disorder, generalized anxiety disorder, fibromyalgia, chronic musculoskeletal pain, and diabetic peripheral neuropathy. It belongs to a class of drugs known as serotonin-norepinephrine reuptake inhibitors. Pharmacists are advised to review their inventory and discontinue dispensing the affected lot immediately.