FDA Recall Notice for Duloxetine Due to High Levels of Nitrosamines

The Food and Drug Administration (FDA) has issued a recall notice for thousands of bottles of the popular antidepressant duloxetine, which is used to treat depression, anxiety, and nerve pain. The recall was initiated due to the presence of nitrosamines, a known carcinogenic compound.

Duloxetine, sold under the brand name Cymbalta, is a common antidepressant belonging to a class of medications called selective serotonin and norepinephrine reuptake inhibitors (SNRI). The drugmaker, Towa Pharmaceutical Europe, recalled over 7,000 bottles of 500-count, 20 mg duloxetine delayed-release capsules that were distributed nationwide.

Nitrosamines are organic compounds found in low levels in water and food, including meat, dairy products, and vegetables. The specific nitrosamine detected in Towa’s duloxetine is called N-nitroso-duloxetine, which can form during chemical reactions in the drug manufacturing process.

The recall, classified as Class II, indicates that the health harms associated with taking the tainted medication are likely temporary or medically reversible, and it’s unlikely to cause serious health outcomes. If you are concerned about your medication being part of the affected batch (lot #220128, expiring on 12/2024), contact your pharmacy for guidance.

It is essential not to abruptly stop taking duloxetine without consulting your healthcare provider first. The FDA advises speaking to your pharmacist or healthcare provider if you have any concerns about the safety of your medication.

If you have further questions about the safety of duloxetine or other medications, you can reach out to the FDA’s Division of Drug Information or consult with your healthcare provider.