July 19, 2021, FDA announced Pfizer's nationwide recall for 12 Lots of ' CHANTIX ' tablets, the smoking cessation treatment since the percentage of N-nitroso Varenicline is above ADI level.
Pfizer is voluntarily recalling two lots of Chantix 0.5mg Tablets, two lots of Chantix 1 mg Tablets, and eight lots of a Chantix kit of 0.5mg/1 mg Tablets to the patient (consumer/user) level due to the presence of a nitrosamine, N-nitroso-varenicline, above the Pfizer established Acceptable Daily Intake (ADI) 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. The health benefits of stopping smoking outweigh the theoretical potential cancer risk from the nitrosamine impurity in varenicline.
Nitrosamines are common in water and foods, including cured and grilled meats, dairy products and vegetables. Everyone is exposed to some level of nitrosamines. These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time.i
Chantix is a treatment to help patients quit smoking and is intended for short term use. People who smoke cigarettes are 15 to 30 times more likely to get lung cancer than people who do not smoke.ii Smoking is also associated with many other cancers.iii CHANTIX has a safety profile that has been established over 15 years of marketing authorization and through a robust clinical program. Pfizer believes the benefit/risk profile of CHANTIX remains positive. Patients currently taking Chantix should consult with their doctor to confirm if they received an affected lot, and if appropriate, about alternative treatment options. To date, Pfizer has not received any reports of adverse events that have been related to this recall.
The NDC, Lot Number, Expiration Date, and Configuration details for Chantix Tablets is indicated in the table below and photos of the products can be found at the end of this press release. The product lots were distributed nationwide to wholesalers and Distributors in the United States and Puerto Rico from June 2019 to June 2021.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
ii U.S. Centers for Disease Control and Prevention. What Are the Risk Factors for Lung Cancer? https://www.cdc.gov/cancer/lung/basic_info/risk_factors.htmUpdated September 2020. Accessed June 2021.
iii U.S. Department of Health and Human Services. Smoking and Cancer (Fact Sheet). Atlanta, GA: US Dept of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health; 2014.