Duloxetine Capsules Recalled Due to Nitrosamine Impurity

The US Food and Drug Administration (FDA) has issued a Class II recall for Duloxetine Delayed-Release Capsules, USP, 60 mg, following the detection of N-nitroso-duloxetine—a probable human carcinogen—above the safety assessment limit of 12.5 ppm. The affected product was manufactured by Towa Pharmaceutical Europe, S.L. in Barcelona, Spain, and distributed by Breckenridge Pharmaceutical, Inc., based in Berkeley Heights, NJ. The voluntary recall, initiated on October 9, 2025, includes 2 packaging configurations:

• 90-count bottles (NDC 51991-748-90), Lot #240721C, Exp. 02/28/2027

• 1000-count bottles (NDC 51991-748-10), Lot #230286C, Exp. 02/28/2026

In total, 172 263 bottles were distributed across the United States.

The recall was classified as Class II by the FDA on October 24, 2025, which means use of the product may cause temporary or medically reversible health consequences, but the probability of serious injury is remote. Nitrosamines have been under increased FDA scrutiny, particularly when they exceed established safety thresholds.

Duloxetine is a serotonin-norepinephrine reuptake inhibitor (SNRI) used to treat several conditions, including major depressive disorder (MDD), generalized anxiety disorder (GAD), diabetic peripheral neuropathic pain, fibromyalgia, and chronic musculoskeletal pain. Pharmacists are advised to identify and quarantine affected lots, notify health care providers, and work with patients who may be impacted to arrange for alternate therapies.

Reference

FDA. Enforcement Report. October 29, 2025. Accessed October 30, 2025. https://www.accessdata.fda.gov/scripts/ires/index.cfm