Pfizer recalls Chantix tablets with N-nitroso-varenicline impurity above FDA limits. Affected lots expire through January 2023. Stop using and contact Pfizer for details.
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acceptable intake limit
Pfizer is recalling Chantix (varenicline) 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 in the U.S. and Canada.
The recall is due to the presence of N-nitroso-varenicline impurity in the tablets, which exceeds the FDA's acceptable interim intake limit. This impurity could potentially cause health risks if the tablets are taken as intended.
People who have the specific Chantix tablet lots listed in the recall notice are affected. Those who have taken the recalled tablets or are prescribed them should check if they have the affected lots.
Check the product label for the specific lot numbers: 00020231 (exp 30 Sept 2021), 00020232 (exp 30 Nov 2021), 00020357 (exp 31 Dec 2021), 00020358 (exp 31 Jan 2022), 00020716 (exp 31 Jan 2022), ET1600 (exp 31 Jan 2023), ET1607 (exp 31 Jan 2023), and ET1609 (exp 31 Jan 2023).
Look for the lot numbers listed in the recall notice to determine if your Chantix tablets are affected.
Reach out to Pfizer directly for further instructions on what to do with the affected tablets.
Pfizer is recalling Chantix tablets that contain N-nitroso-varenicline impurity above the FDA's acceptable interim intake limit.
Check the product label for the specific lot numbers listed in the recall notice. If you have the affected lots, contact Pfizer for further instructions.
The recall is due to the presence of N-nitroso-varenicline impurity above FDA limits, which could pose health risks if taken as directed.
We’ve drafted a message you can send Pfizer to request your refund or repair — edit it as you like.
Subject: Recall D-0700-2021 — Pfizer Pfizer Hello, I own a Pfizer that is covered by recall D-0700-2021 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.
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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.
