Pfizer recalls Chantix 0.5mg/1mg tablets with N-nitroso-varenicline impurity above FDA limits. Affected lots from January 2023 to August 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 (varenicline) tablets that contain an impurity above the FDA's acceptable limit. This impurity could pose a health risk if taken as directed. The recall affects specific lots manufactured between January 2023 and August 2021.
The tablets contain a chemical impurity called N-nitroso-varenicline that exceeds the FDA's acceptable limit. This impurity could potentially cause health issues if the medication is taken as directed. The exact health risk is not clearly specified in the recall notice.
People with prescriptions for Chantix 0.5mg/1mg tablets from the listed lots are affected. Those who have these specific batches and are taking the medication are at risk.
Check the product label for the lot numbers listed: 00018522, 00018523, 00018739, 00018740, 00020231, 00020232, 00020357, 00020358, 00020716, 00020813, 00021288, 00021289, 00021420, 00021687, 00021688, 00021788, 00021789, 00021790, 00021791, 00021792, 00022819, 00022851, 00023136, 00023137, 00023190, 00023448, DM0275, DM0276, DM0277, DY4470, EC5911, EC5912, ED6814, ET1600, ET1603, ET1607, ET1609, ET1611. The product was made in Ireland and expires by August 2021.
Look for the lot numbers listed in the recall notice to determine if your Chantix tablets are affected.
The recall is due to the presence of N-nitroso-varenicline impurity above the FDA's acceptable limit.
The recall notice does not specify a remedy, so contact Pfizer directly for guidance.
Yes, the affected lot numbers are listed in the recall notice: 00018522, 00018523, 00018739, 00018740, 00020231, 00020232, 00020357, 00020358, 00020716, 00020813, 00021288, 00021289, 00021420, 00021687, 00021688, 00021788, 00021789, 00021790, 00021791, 00021792, 00022819, 00022851, 00023136, 00023137, 00023190, 00023448, DM0275, DM0276, DM0277, DY4470, EC5911, EC5912, ED6814, ET1600, ET1603, ET1607, ET1609, ET1611.
Check the product label for the lot numbers listed in the recall notice.
We’ve drafted a message you can send Pfizer to request your refund or repair — edit it as you like.
Subject: Recall D-0808-2021 — Pfizer Pfizer Hello, I own a Pfizer that is covered by recall D-0808-2021 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.
