FDA Announces Recall of Certain Duloxetine Products Due to Elevated Nitrosamine Levels

The U.S. Food and Drug Administration (FDA) has announced the recall of certain lots of duloxetine, a widely prescribed medication used to treat depression and anxiety, after testing detected elevated levels of a nitrosamine impurity known as N-nitroso-duloxetine.

The recall was voluntarily initiated by manufacturer Towa Pharmaceutical and distributor Breckenridge Pharmaceutical Inc. after the impurity was found at levels exceeding FDA-recommended safety thresholds.

According to the FDA, nitrosamines are compounds that may increase the risk of cancer when individuals are exposed to them at elevated levels over extended periods. However, the agency emphasizes that exposure at or below established daily intake limits is not expected to significantly increase cancer risk.

N-nitroso-duloxetine belongs to the nitrosamine family of compounds, some of which are classified as probable human carcinogens based on laboratory studies. While there is currently no direct evidence linking this specific impurity to cancer in humans, regulators continue to monitor and evaluate potential long-term risks associated with excessive exposure.

The FDA has classified the action as a Class II recall, meaning that use of the affected products may cause temporary or medically reversible health effects, while the likelihood of serious adverse health consequences is considered low.

Health experts advise patients not to stop taking duloxetine abruptly, as sudden discontinuation may cause withdrawal symptoms or worsen underlying medical conditions. Individuals who believe they may have affected medication should contact their healthcare provider or pharmacist to discuss replacement options and the most appropriate course of action.

The FDA continues to monitor the situation and recommends that consumers follow official recall guidance while consulting medical professionals regarding any concerns about their prescriptions.