Pfizer Recalls All Lots of Smoking Cessation Drug Chantix

To date, Pfizer has not received reports of adverse events related to this recall, but is making the move as a precaution.

Pfizer is voluntarily recalling all remaining lots of Chantix (varenicline) 0.5 mg and 1 mg tablets because of the presence of a nitrosamine, which may be associated with an increased risk of cancer.

Chantix is a treatment to help patients quit smoking and is intended for short term use. The products were distributed nationwide to wholesalers and distributors in the United States, U.S. Virgin Islands, and Puerto Rico from May 2019 to September 2021.

The NDC, lot numbers, and expiration date affected can be found here.

This announcement follows several other recalls made over the last few months when 16 lots of Chantix had been recalled.

Pfizer officials say they are making this move as precaution since other options are now available. Last month, the FDA 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.

Additionally, In July after Pfizer’s initial recalls, Apotex Corp., in coordination with the FDA, initiated temporary importation of Apo-Varenicline (varenicline tartrate) 0.5 mg and 1 mg tablets into the U.S. market. Apo-Varenicline is the varenicline tartrate product approved by Health Canada as a generic equivalent to Champix tablets manufactured by Pfizer Canada. Champix is the brand name of Chantix in Canada.