Pfizer recalls Chantix 0.5mg tablets due to potential N-nitroso-varenicline impurity above FDA limits. Affected lots made in Ireland with specific NDC numbers.
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 taken by people who need the medication.
The tablets may 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 directed.
People with prescriptions for Chantix 0.5mg tablets made in Ireland between 2021 and 2023 are affected. Those who have taken the recalled tablets without knowing they were recalled are at risk.
Check for the product name 'Chantix 0.5mg tablets', 56 tablets, prescription-only. Look for NDC number 0069-0468-56 and lots CY6861, DM9007, DM9008, EN5725, EN8362, EN8467. The expiration date is between January 2022 and May 2023.
Look for the NDC number 0069-0468-56 and specific lots listed in the recall notice.
The recall states the tablets may contain an impurity above FDA limits, so they are not safe to use as recalled.
Check for the NDC number 0069-0468-56 and lots CY6861, DM9007, DM9008, EN5725, EN8362, EN8467 on the packaging.
The recall does not specify a remedy, so contact Pfizer directly for guidance.
We’ve drafted a message you can send Pfizer to request your refund or repair — edit it as you like.
Subject: Recall D-0809-2021 — Pfizer Pfizer Hello, I own a Pfizer that is covered by recall D-0809-2021 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.
