Thousands of bottles of duloxetine have been recalled after federal regulators found the antidepressant contained levels of a potentially cancer-causing impurity above safety limits. The U.S. Food and Drug Administration said the action involves N-nitroso-duloxetine and classified it as a Class II recall.
The pills were voluntarily recalled by manufacturer Towa Pharmaceutical and are distributed by Breckenridge Pharmaceutical Inc. Duloxetine is a prescription medicine used to treat depression and anxiety, putting the recall squarely in front of patients who may already be taking it for ongoing care.
In its notice, the FDA said nitrosamine impurities may increase the risk of cancer if people are exposed to them above acceptable levels and over long periods of time. It also said people exposed to those impurities at or below the acceptable daily intake limit are not expected to have an increased risk of cancer.
The agency added that there is no specific evidence linking N-nitroso-duloxetine directly to cancer. That leaves the recall in a familiar but uncomfortable place for regulators and patients: the product has crossed federal safety limits, but the harm signal is based on the impurity’s long-term exposure risk rather than proof of disease in people who took these bottles.
A Class II recall means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or that the probability of serious adverse health consequences is remote. The FDA did not say how many specific lots were affected or what patients should do next, and it was not immediately clear whether more bottles could be pulled from the market.
For now, the recall turns a widely used antidepressant into an immediate safety issue for pharmacies and patients alike. What remains unresolved is whether the affected supply is limited to the bottles already identified, or whether the same impurity will force a wider drug recall.
