Breckenridge Pharmaceutical Recalls Duloxetine Capsules Due to Impurity Concerns

Breckenridge Pharmaceutical, Inc has issued a voluntary nationwide recall of Duloxetine Delayed-Release Capsules, USP, 60 mg, after detecting N-nitroso-duloxetine impurity levels above the US Food and Drug Administration’s (FDA) recommended interim limit. The recalled product, distributed in 1000-count bottles, was manufactured by Towa Pharmaceutical Europe, S.L. in Barcelona, Spain, and is identified by NDC 51991-748-10. The recall affects 11 100 bottles of duloxetine capsules that were distributed nationwide. Affected units belong to lot #240301C, which has an expiration date of January 2027.

The recall, initiated on February 28, 2025, is classified as Class II, indicating that exposure to the product may cause temporary or medically reversible adverse health consequences, though the likelihood of serious harm is low. The presence of N-nitroso-duloxetine raises potential safety concerns, as nitrosamine-related impurities have been linked to carcinogenic risks when present above established safety thresholds. Breckenridge Pharmaceutical notified its consignees via letter, and the recall remains ongoing as of March 2025.

Duloxetine is a serotonin-norepinephrine reuptake inhibitor commonly prescribed for major depressive disorder, generalized anxiety disorder, fibromyalgia, and neuropathic pain associated with diabetes. Pharmacists should review inventory for affected lot numbers and cease dispensing recalled units immediately. Patients currently taking duloxetine should consult their health care provider for guidance regarding alternative options. While no official press release has been issued, pharmacists and health care providers should remain alert for further updates from the FDA and Breckenridge Pharmaceutical.