Pfizer recalls anti-smoking drug due to high levels of ingredient tied increased risk of cancer

Pfizer recalled its anti-smoking drug Chantix due to high levels of an ingredient that is tied to an increased risk of cancer.

In a notice posted to the Food and Drug Administration’s (FDA) website on Thursday, Pfizer said it was recalling Chantix 0.5 mg and 1 mg tablets to the consumer level due to the presence of N-nitroso-varenicline.

Long term ingestion of N-nitroso-varenicline can be associated with a “theoretical potential increased cancer risk in humans,” the notice said. However, there is no immediate risk to patients taking the drug.

The company said it is undertaking the recall as a precautionary measure, adding that the benefits of stopping smoking “outweigh the theoretical potential cancer risk from the nitrosamine impurity.”