Popular Antidepressant Recalled Over Possible Cancer-Causing Impurity Risk

A major recall involving duloxetine has raised concern because the medicine is widely used and often taken as part of a carefully managed mental health or pain-treatment plan. The issue is not about a wrong label or a packaging mistake, but an impurity tied to a possible long-term cancer risk.

Breckenridge Pharmaceutical, Inc. recalled nearly 375,000 bottles on June 4, 2026, after higher-than-acceptable levels of nitrosamines were identified. The FDA classified the recall as Class II on June 8, meaning the affected drugs may cause temporary or medically reversible health consequences, while the probability of serious consequences is remote.