Duloxetine Recall: What You Need to Know About the Latest Safety Concerns

Thousands of bottles of the antidepressant duloxetine, commonly known by its brand name Cymbalta, have been recalled due to the presence of a potentially toxic chemical. The U.S. Food and Drug Administration (FDA) announced the recall on October 10, affecting 7,101 bottles of 20mg delayed-release capsules manufactured by Towa Pharmaceutical Europe. This recall is classified as a Class II, which means that exposure could lead to temporary or medically reversible health consequences, though the risk of severe health issues is low.

The reason for the recall is the detection of N-nitroso-duloxetine, a chemical compound that can be toxic at elevated levels and is suspected of being carcinogenic. Nitrosamines, like N-nitroso-duloxetine, are contaminants that can appear in various products, including pharmaceuticals. The FDA has established acceptable daily intake thresholds for these compounds, and any levels above this threshold raise health concerns.

Patients who are currently taking duloxetine are advised not to stop their medication abruptly, as doing so can lead to withdrawal symptoms or a worsening of their condition. Instead, it is recommended that they consult with their healthcare providers to discuss alternative treatment options or next steps.

This situation highlights the importance of monitoring pharmaceutical products for safety and efficacy. As consumers, it’s essential to stay informed about recalls and potential risks associated with medications. If you have duloxetine from the affected lot number 220128 (expiring December 2024), reach out to your healthcare provider for guidance on how to proceed safely.