Pfizer Chantix 0.5mg Tablets Recall: N-nitroso-varenicline Impurity Risk
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).
Lower-risk recall
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
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What happened, in plain English
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. Read more at govinfonow.com/recall/36120-pfizer-chantix-0-5mg-tablets-recall-n-nitroso-varenicline-impurity.
Source Summary by GovInfoNow · govinfonow.com/recall/36120-pfizer-chantix-0-5mg-tablets-recall-n-nitroso-varenicline-impurity · Updated August 18, 2026 · FDA enforcement record: FDA #D-0699-2021
Cite this page
“Pfizer Chantix 0.5mg Tablets Recall: N-nitroso-varenicline Impurity Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/36120-pfizer-chantix-0-5mg-tablets-recall-n-nitroso-varenicline-impurity. Based on FDA recall #D-0699-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0699-2021%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
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.
- Brand
Pfizer- Category
Drug
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
Nationwide- NDC
0069-0468-56, 0069-0469-56, 0069-0469-28, 0069-0471-03, 0069-0471-28
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0699-2021 | Chantix (varenicline) tablets, 0.5mg*, 56 Tablets, Rx Only, Distributed by Pfizer Labs, Division of Pfizer Inc., NY, NY 10017, Made in Ireland. NDC 0069-0468-56; Lots 00019213, Exp 31 Jan 2022 & EC6994, Exp May 31, 2023 | 59,232 bottles |
| D-0700-2021 | Chantix (varenicline)Tablets, Contains: 1 Starting Week (0.5 mg* x 11 tablets), 3 Continuing Weeks (1 mg x 42 tablets), Rx Only, Distributed by Pfizer Labs, Division of Pfizer Inc, NY, NY 10017, Made in Ireland, NDC 0069-0471-03.; Lots 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 & ET1609, Exp 31, Jan 2023. | 350,985 cartons |
| D-0701-2021 | Chantix (varenicline) tablets, 1 mg, 56 Tablets, Rx Only, Distributed by Pfizer Labs, Division of Pfizer Inc., NY, NY 10017, Made in Ireland. NDC 0069-0469-56; Lots EC9843, Exp 31, Mar 2023; EA6080, Exp. 31, Mar 2023. | 69,6396 bottles |
What to do — step by step
Check Product Label
Look for the NDC code 0069-0468-56 and lot numbers 00019213 (expiring Jan 31, 2022) or EC6994 (expiring May 31, 2023).
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 2 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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.
- Official source: FDA Recall #D-0699-2021 (June 9, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0699-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.