Pfizer recalls Chantix 1mg tablets with N-nitroso-varenicline impurity above FDA limits. Affected lots from June 2023 to September 2021. Stop using if you have these specific lots.
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Pfizer is recalling Chantix 1mg tablets that contain a harmful impurity above FDA safety limits. This impurity could pose a health risk if taken as directed. Affected products were distributed with specific lot numbers between June 2023 and September 2021.
The Chantix tablets contain an impurity called N-nitroso-varenicline that exceeds the FDA's acceptable safety limit. This impurity could potentially cause health issues if the medication is taken as intended, though the risk is considered low based on current testing.
People who have prescription Chantix 1mg tablets with the specific lot numbers listed in the recall. Those who have taken the medication without proper medical supervision are at higher risk.
Check the product label for the lot numbers listed: 00019431, 00019542, 00019543, 00019544, 00020814, and other specific numbers. The product was made in Ireland and expires by September 2021 or December 2023.
Look for the lot numbers on the Chantix tablet carton: 00019431, 00019542, 00019543, 00019544, 00020814, and other specific numbers listed in the recall.
If you have the recalled lot numbers, stop using the Chantix tablets immediately and contact your doctor for guidance.
Pfizer is recalling Chantix 1mg tablets because they contain an impurity called N-nitroso-varenicline that exceeds the FDA's acceptable safety limit.
If you have the specific lot numbers listed in the recall, stop using the Chantix tablets and contact your doctor for advice.
No, this recall only applies to Chantix 1mg tablets with the specific lot numbers listed in the record.
We’ve drafted a message you can send Pfizer to request your refund or repair — edit it as you like.
Subject: Recall D-0811-2021 — Pfizer Pfizer Hello, I own a Pfizer that is covered by recall D-0811-2021 from Pfizer. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
