Pfizer has announced a recall of varenicline, the anti-smoking drug sold under the brand name Chantix, for the second time in two weeks. Both recalls, the latest on Friday, concern the presence of N-nitroso-varenicline.
Pfizer says these lots have more than the company’s, not the FDA’s, acceptable daily Intake level.
“Long-term ingestion of N-nitroso-varenicline may be associated with a theoretical potential increased cancer risk in humans, but there is no immediate risk to patients taking this medication,” says the Pfizer-written, FDA-posted recall notice. “The health benefits of stopping smoking outweigh the theoretical potential cancer risk from the nitrosamine impurity in varenicline.”