A total of 16 lots have been recalled.
Pfizer is recalling an additional four lots of Chantix (varenicline) 0.5mg/1 mg tablets due to the presence of a nitrosamine, N-nitroso-varenicline. This now makes a total of 16 lots that have been recalled.
N-nitroso-varenicline may be associated with a potential increased cancer risk in humans.
The product lots were distributed nationwide to wholesalers and distributors in the United States and Puerto Rico from June 2019 to June 2021.
Last month, Pfizer recalled nine lots and then an additional three lots of Chantix. A list of the lot numbers can be found here on the FDA’s website.
This additional recall comes just days after the regulatory agency approved the first generic version of Chantix. Developed by Par Pharmaceutical, which is part of Endo International, the generic varenicline tablet was approved August 11, 2021. The generic will come in doses of 0.5 mg and 1 mg.