Pfizer is recalling batches of the anti-smoking drug Chantix because of a high level of a substance that could increase a user’s risk of developing cancer.
The Food and Drug Administration (FDA) says the pharmaceutical company is recalling two lots of Chantix .5 mg tablets, two lots of Chantix 1 mg tablets, and eight lots of a Chantix kit of 0.5 mg/1 mg tablets due to the presence of a nitrosamine called N-nitroso-varenicline that’s above the acceptable daily intake level.
According to the FDA, long-term ingestion of the substance may be associated with an increased cancer risk in humans, but there is no immediate risk to patients taking the medication.
Officials say the health benefits of stopping smoking outweigh the potential cancer risk from the nitrosamine impurity in varenicline.
The FDA says nitrosamines are common in water and foods, including cured and grilled meats, dairy products, and vegetables. The impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time, officials said.
Patients currently taking Chantix should consult with their doctor to confirm if they received an affected lot, and if appropriate, discuss alternative treatment options.
To date, Pfizer says it has not received any reports of adverse events that have been related to this recall.
The affected products were distributed nationwide to wholesalers and distributors in the U.S. and Puerto Rico from June 2019 to June 2021. Click here to see the NDC, lot number, expiration date, and configuration details for the affected tablets.
Adverse reactions or quality problems experienced with the use of these products may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.