Recall of Chantix Due to Impurity

FDA is alerting patients and health care professionals to Pfizer’s voluntary recall of nine lots of the smoking cessation drug, varenicline (brand name Chantix), to the warehouse level. The company is recalling varenicline because it may contain levels of a nitrosamine impurity, called N-nitroso-varenicline, above FDA’s acceptable intake limit. N-nitroso-varenicline may be associated with a potential increased cancer risk in humans, but there is no immediate risk to patients taking this medication. An increased cancer risk would be associated with long-term use, and the health benefits of stopping smoking outweigh the cancer risk from the nitrosamine impurity in varenicline.

Pfizer is recalling the varenicline lots currently stored in warehouses. FDA recommended Pfizer revise its recall to the consumer level in order to take into account the product currently on the market, but the company has not yet done so.

In addition to the voluntary recall, Pfizer is holding release of varenicline to the U.S. market until it can confirm N-nitroso-varenicline levels below what the company considers to be acceptable.

Patients should know:

• Continue taking your current medicine until your doctor or pharmacist gives you a replacement or a different treatment option.

• Contact your health care professional if you are taking this medication and have questions about your health.

Healthcare professionals should know:

• FDA has determined the recalled varenicline poses an unnecessary risk to patients. Therefore, FDA recommends health care professionals consider other available treatment options for the patient’s medical condition.

If you have varenicline samples from this company, quarantine them, and do not provide them to patients.

• Contact Pfizer directly if you have questions regarding product return or disposa