Pfizer yanks 12 Chantix lots on carcinogen concerns after pausing global shipments last month

Pfizer, which put global Chantix distribution on hold late last month, is escalating its response to discovering a potential cancer-causing agent in the drug.

Pfizer has recalled 12 Chantix tablet lots with levels of the likely carcinogen N-nitroso-varenicline—a type of nitrosamine—above Pfizer's pre-set Acceptable Daily Intake (ADI) level, the company said in a notice posted on the FDA's website. The move expands on a recall—covering 9 lots—issued to warehouses last week.