Over 200,000 duloxetine bottles recalled due to carcinogenic chemical

The pharmaceutical industry has recalled over 233,000 bottles of duloxetine, a popular antidepressant. The recall started in November 2024 and is classified as a Class II recall by the Food and Drug Administration (FDA). It is caused by the presence of excessive levels of N-nitroso-duloxetine, a nitrosamine impurity that has been linked to cancer. Sold under brand names like Cymbalta, duloxetine is a serotonin and norepinephrine reuptake inhibitor (SNRI) used to treat depression and anxiety. Nitrosamines can form during the manufacturing or chemical processing of the product, and they are known to increase cancer risk. The FDA’s Class II classification indicates an intermediate risk with “temporary or medically reversible adverse health consequences.” However, the widespread use of the drug makes the issue concerning for health authorities. According to Jamie Alan, a pharmacology expert, the contamination reflects ongoing problems in the pharmaceutical manufacturing process, which have caused the recalls of other medications like valsartan and Zantac. Meanwhile, patients reliant on duloxetine are concerned about the safety of their treatment, as an abrupt interruption of medication can lead to several symptoms like nausea, anxiety, and headaches. Experts advise talking with doctors and other healthcare providers to identify alternative drugs to replace duloxetine. Patients are also encouraged to report adverse reactions to the FDA’s MedWatch program.
Since 2018, nitrosamine-related recalls have affected over 12 million bottles of various medications. This emphasizes the need for improved manufacturing oversight and testing in the pharmaceutical industry. Companies face increasing pressure over contamination issues, while the FDA is adopting enhanced monitoring practices to protect public health.