CHANTIX 0.5 miligram and 1 miligram Tablets

On September 16, 2021, Pfizer, the manufacturer of Chantix®, expanded their recall to include all lots of the drug.

October 07, 2021  

This recall was issued due to the presence of a nitrosamine, N-nitroso-varenicline, at or above the FDA interim acceptable intake limit. Long-term ingestion of N-nitroso-varenicline may be associated with a theoretical potential increased cancer risk in humans, but there is no immediate risk to patients taking this medication.

What do you need to do?

  • Do not stop taking your medication without speaking with your doctor.
  • Please call your doctor to determine if an alternate treatment would be appropriate for you. Your doctor will be able to prescribe another medication for you so you can continue treating your condition without interruption.

For more information or to report any adverse events or quality problems experienced with the use of this product may be made directly to Pfizer, or you can report to the FDA's MedWatch Program.

Manufacturer Information

Pfizer Medical Information (For medical questions):

Pfizer Drug Safety (To report adverse events):

  • 1-800-438-1985, option 1 (24 hours a day, 7 days a week)

To report an adverse event to the FDA Med Watch Program



Affected Products and NDC Numbers:

Drug NDC
Chantix 0.5mg 00069-0468-56
Chantix 1mg 00069-0469-56
Chantix Starter Pack 00069-0471-03