Pfizer recalls Chantix 0.5mg tablets due to potential presence of N-nitroso-varenicline impurity above FDA safety limits. Affected lots: 00019213 (exp 31 Jan 2022) and EC6994 (exp May 31, 2023).
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Pfizer is recalling Chantix 0.5mg tablets that may contain an impurity exceeding FDA safety limits. This could pose a health risk if the impurity is ingested. Affected products were made in Ireland and distributed through specific lot numbers.
The tablets may contain N-nitroso-varenicline, an impurity that exceeds the FDA's acceptable safety limit. This impurity could potentially cause health issues if consumed in amounts above the safety threshold.
People with a prescription for Chantix 0.5mg tablets (56 tablets) made in Ireland, lot numbers 00019213 (expiring Jan 31, 2022) or EC6994 (expiring May 31, 2023). Those who have taken the product since its distribution are most at risk.
Check the product label for the NDC code 0069-0468-56 and lot numbers 00019213 (expiring Jan 31, 2022) or EC6994 (expiring May 31, 2023). The product was made in Ireland and distributed by Pfizer Labs.
Look for the NDC code 0069-0468-56 and lot numbers 00019213 (expiring Jan 31, 2022) or EC6994 (expiring May 31, 2023).
The recall is due to the presence of N-nitroso-varenicline impurity above FDA's acceptable safety limit.
Lots 00019213 (expiring Jan 31, 2022) and EC6994 (expiring May 31, 2023).
Check the product label for NDC code 0069-0468-56 and lot numbers 00019213 or EC6994.
We’ve drafted a message you can send Pfizer to request your refund or repair — edit it as you like.
Subject: Recall D-0699-2021 — Pfizer Pfizer Hello, I own a Pfizer that is covered by recall D-0699-2021 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.
