Antidepressant Recalled for Impurity

Breckenridge Pharmaceutical Inc. is recalling 7107 bottles of duloxetine delayed-release capsules because of an N-nitroso duloxetine impurity, according to the October 23, 2024, US Food and Drug Administration (FDA) Enforcement Report. The recall follows a similar recall the firm initiated for the drug earlier this year. 

The most recent recall affects duloxetine delayed-release capsules, 20 mg, in 500-count bottles (NDC 51991-746-05) from lot 220128 (Exp. 12/24). The product was manufactured by Towa Pharmaceutical Europe SL and distributed throughout the United States by BPI.

Breckenridge Pharmaceutical voluntarily initiated the recall October 10, 2024. The FDA designated the recall Class II on October 11, 2024. Per the classification, use of the affected drug could cause temporary or medically reversible adverse health consequences. While remote, the possibility of serious harm also exists.

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