370,000 bottles of widely used antidepressant recalled because they contain a cancer-causing chemical

A significant recall is underway involving approximately 370,000 bottles of a popular antidepressant. The U.S. Food and Drug Administration has flagged the medication due to the presence of a cancer-causing chemical at levels that exceed safety limits.

Understanding the Recall

The recall involves Duloxetine Delayed-Release Capsules, frequently marketed under the brand name Cymbalta. According to the Mayo Clinic, this medication is widely prescribed to help manage depression, anxiety, and fibromyalgia.

Breckenridge Pharmaceuticals, Inc. initiated the recall after discovering that the capsules contain an impurity known as N-nitroso-duloxetine. Documents from the enforcement report confirm these levels surpass the FDA's recommended safety threshold.

Health Concerns and Classification

The National Library of Medicine notes that N-nitroso-duloxetine is considered toxic if ingested and is suspected of being carcinogenic. The California Board of Pharmacy warned in an alert that exposure to these impurities over extended periods may heighten cancer risks.

Regulators have categorized this as a Class II recall. This classification indicates that while the product may cause temporary health issues, serious adverse outcomes are considered unlikely.

Impacted Products and Background

The affected capsules were manufactured by Towa Pharmaceutical Europe in Spain and distributed by Breckenridge Pharmaceuticals. The recall covers both 30-mg and 60-mg doses, specifically impacting bottles of 90 and 1,000 capsules. Affected lot codes include: 241074C, 240317, 240318, 240315C, 240373C, 240370C, 240375C, 240413C, 240316, 232311, 240978C, 241052C, and 241180C.

This is not the first time Breckenridge Pharmaceuticals has faced such issues; the company previously recalled more than 7,000 bottles of Duloxetine in 2024. 205focus.com will continue to monitor updates regarding this health alert.