Duloxetine Capsules Recalled Over Nitrosamine Impurity

Breckenridge Pharmaceutical Inc, in coordination with Quallent Pharmaceuticals Health LLC and manufacturer Towa Pharmaceutical Europe, has initiated a voluntary recall of Duloxetine Delayed-Release Capsules, USP, 30 mg. The affected product is packaged in bottles of 1000 capsules (NDC: 82009-030-10) and carries lot number 240927C with an expiration date of April 30, 2027. A total of 3591 bottles are subject to recall. The recall, classified as Class II, was initiated on August 8, 2025, and remains ongoing. Product distribution was limited to the states of Arizona, Indiana, and New Jersey.

The recall stems from current good manufacturing practice (CGMP) deviations involving the detection of an N-nitroso-duloxetine impurity exceeding the proposed interim limit. N-nitroso impurities are a class of nitrosamines, which are considered potential human carcinogens. The US Food and Drug Administration (FDA) has been closely monitoring such impurities across multiple drug classes, leading to several recalls in recent years. While a Class II recall indicates that exposure to the drug could cause temporary or medically reversible adverse health consequences, it is not deemed to pose an immediate, life-threatening risk. Consignees were notified of the recall via letter.

Pharmacists should be aware that the recall affects stock handled in bulk quantities, as these bottles are intended for repackaging or institutional dispensing. Duloxetine, a serotonin-norepinephrine reuptake inhibitor (SNRI), is widely prescribed for major depressive disorder, generalized anxiety disorder, diabetic peripheral neuropathic pain, fibromyalgia, and chronic musculoskeletal pain. Pharmacists managing inventory in affected states should check for recalled lots, quarantine affected product, and follow the recall instructions to ensure patient safety and regulatory compliance.