Due to the presence of a nitrosamine, N-nitroso-varenicline, above the established Acceptable Daily Intake (ADI), 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.

The FDA has released the following