Pfizer Recalls Smoking Cessation Drug Chantix, Citing Presence of Possible Carcinogen

WASHINGTON, D.C. — Pfizer is recalling all lots of Chantix 0.5 mg and 1 mg. tablets due to the presence of a possible carcinogen, N-nitroso-varenicline, at or above acceptable limits, the Food and Drug Administration has announced.

In a Sept. 17 MedWatch alert, the agency explained that Pfizer has not received reports of adverse events related to the recall and that “the health benefits of stopping smoking outweigh the theoretical potential cancer risk from the nitrosamine impurity in varenicline.”

“Long-term ingestion of N-nitroso-varenicline may be associated with a theoretical potential increased cancer risk in humans, but there is no immediate …