On September 16, 2021, Pfizer issued a voluntary recall of all lots of Chantix 0.5 mg and 1 mg tablets because of the presence of nitrosamine, N-nitroso-varenicline, at or above the U.S. Food and Drug Administration’s (FDA) acceptable limit.

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.

To date, Pfizer has not received reports of adverse events related to this recall.

For more information, please visit FDA.gov. You can also contact Pfizer Medical Information or call 1-800-438-1985 (TTY 711), option 3, weekdays, from 9 a.m. to 5 p.m. The Horizon NJ Health Pharmacy Help Desk is available at 1-800-682-9094 x81016 (TTY 711), weekdays, 8 a.m. to 5:30 p.m., and Saturday, 8 a.m. to 4:30 p.m.