Selective Serotonin and Norepinephrine Reuptake Inhibitor Recalled

Jolynn Tumolo

Breckenridge Pharmaceutical Inc. is recalling 165,678 bottles of duloxetine delayed-release capsules because of an N-nitroso duloxetine impurity, according to the June 26, 2024, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects 90-count bottles of duloxetine delayed-release capsules, 60 mg (NDC 51991-748-90), from lots 230035C (Exp. 11/30/25) and 230101C (Exp. 12/31/25). The drug was manufactured by Towa Pharmaceutical Europe SL, Martorelles, Barcelona, Spain, and was distributed throughout the United States by Breckenridge Pharmaceutical, Berkeley Heights, New Jersey.

Breckenridge Pharmaceutical voluntarily initiated the recall on May 17, 2024. On June 20, 2024, the FDA designated the recall Class II. Drugs affected by Class II recalls may cause temporary or medically reversible adverse health consequences if used, or a remote possibility of serious harm.

Duloxetine is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) with indications for major depressive disorder, generalized anxiety disorder, diabetic peripheral neuropathic pain, fibromyalgia, and chronic musculoskeletal pain.