August 19, 2021
On July 19, 2021, Pfizer voluntarily recalled 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 at the patient level due to the presence of a nitrosamine, N-nitroso-varenicline,
above the Pfizer established Acceptable Daily Intake (ADI) level.
Patients currently taking Chantix are advised to 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.
For details about the recalled products including product name, lot number, and expiration date, visit the Food and Drugs Administration website.