Pfizer recalls Chantix 1mg tablets with N-nitroso-varenicline impurity above FDA limits. Affected lots and expiration dates listed. Stop using if you have these specific products.
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Pfizer is recalling Chantix 1mg tablets due to a chemical impurity that may exceed FDA safety limits. This recall affects specific batches made in Ireland with certain lot numbers and expiration dates. The impurity could pose a health risk if taken as directed.
The recall involves a chemical impurity called N-nitroso-varenicline that exceeds the FDA's acceptable safety limit. This impurity could cause health problems if the medication is taken as intended. The exact health risks are not specified in the recall notice.
People with prescriptions for Chantix 1mg tablets from the listed lots and expiration dates are affected. Those who have taken the recalled tablets are at risk of potential health issues.
Check your Chantix 1mg tablets for the lot numbers listed in the recall (e.g., 00018777, CW1565, etc.) and expiration date of September 2021 or December 2023.
Look for the lot numbers and expiration date on your Chantix 1mg tablets to see if they match the recalled items.
The recall is due to the presence of N-nitroso-varenicline impurity above the FDA's acceptable safety limit.
The recall notice does not specify a remedy, so contact your pharmacist or healthcare provider for guidance.
Yes, check for lot numbers like 00018777, CW1565, and expiration dates of September 2021 or December 2023.
We’ve drafted a message you can send Pfizer to request your refund or repair — edit it as you like.
Subject: Recall D-0810-2021 — Pfizer Pfizer Hello, I own a Pfizer that is covered by recall D-0810-2021 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.
