FDA Testing Reveals Contamination in Antidepressant Duloxetine
Breckenridge Pharmaceuticals, based in New Jersey, has issued an urgent recall for specific lots of duloxetine delayed-release capsules, the generic version of the antidepressant Cymbalta. The recall follows testing by the US Food and Drug Administration (FDA) that found levels of N-nitroso-duloxetine exceeding the maximum acceptable limit. N-nitroso-duloxetine belongs to a class of nitrosamine compounds classified as probable human carcinogens, meaning long-term exposure above safe levels may increase cancer risk due to cellular damage.
Affected Batches and Distribution
The recall applies to 30 mg capsules with expiration date April 2027 and lot code 241180C, as per the FDA. Additionally, two lots of 60 mg capsules are recalled: one with expiry February 2026 and lot number 230286C, and another with expiry February 2027 and lot number 24072lC, according to a separate notice from the California Board of Pharmacy. The affected products were distributed throughout the United States and have not been sold in the United Kingdom.
Uses of Duloxetine and Health Risks
Duloxetine, a selective serotonin and norepinephrine reuptake inhibitor (SSNRI), is prescribed for depression, general anxiety disorder in adults and children, and nerve pain from diabetic neuropathy, chronic muscle or joint pain, osteoarthritis, and fibromyalgia. The FDA warns that prolonged exposure to nitrosamines above acceptable levels can cause cellular damage, increasing cancer risk over time.
Patient Guidance
Patients with recalled medication are advised to contact their doctor or pharmacist for next steps. It is critical not to abruptly stop taking the medication without consulting a healthcare professional, as sudden discontinuation can cause withdrawal symptoms or worsening of the underlying condition.
