Pfizer recalls Chantix 0.5mg tablets: N-nitroso-varenic: impurity risk
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.
Recall notice
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Contact the company
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 taken by people who need the medication. Read more at govinfonow.com/recall/35939-pfizer-recalls-chantix-0-5mg-tablets-n-nitroso-varenic-impurity.
Source Summary by GovInfoNow · govinfonow.com/recall/35939-pfizer-recalls-chantix-0-5mg-tablets-n-nitroso-varenic-impurity · Updated August 18, 2026 · FDA enforcement record: FDA #D-0809-2021
Cite this page
“Pfizer recalls Chantix 0.5mg tablets: N-nitroso-varenic: impurity risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35939-pfizer-recalls-chantix-0-5mg-tablets-n-nitroso-varenic-impurity. Based on FDA recall #D-0809-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0809-2021%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
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.
- Brand
Pfizer- Category
Drug
All 4 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
| Recall number | Product, codes & lots | Quantity | NDC |
|---|---|---|---|
| D-0808-2021 | Chantix (varenicline) tablets 0.5mg/1mg, 56 Tablets, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Ireland, NDC 00069-0471-03. carton containing one blister pack of 11 0.5 mg tablets and one blister pack containing 42.1 mg tablets.; Lots 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 EXPIRATION DATE: August 2021 January 2023 | — | — |
| D-0809-2021 | 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 , CY6861, DM9007, DM9008, EN5725, EN8362, EN8467 EXPIRATION DATE: January 2022 - May 2023 | — | 0069-0468-56, 0069-0469-56, 0069-0469-28, 0069-0471-03, 0069-0471-28 |
| D-0810-2021 | 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 00018777, 00019289, 00019593, 00019682, 00019846, 00019977, 00020295, 00020448, 00020458, 00020480, 00021024, 00021073, 00021074, CW1565, CW1566, CW1567, CW1568, CW1569, CW1570, CW1571, CW1572, CW1573, CW1574, CW1575, CW1578, CW1579, CW1581, DF5277, DF5278, DF5279, DF5280, DF5281, DF5282, DR5086, DR5092, DR5093, DR5094, DT3885, DW4148, DW4152, DY7987, EC9841, EC9842, EC9847, EC9848, EE1011, EM1069, EM1070, EN5694, EN5695, EP1717, EP1718, EP1719, EW2012, EW3854, EW3865, EX2102, EX2103 EXPIRATION DATE: September 2021 December 2023 | — | 0069-0468-56, 0069-0469-56, 0069-0469-28, 0069-0471-03, 0069-0471-28 |
| D-0811-2021 | Chantix (varenicline) tablets 1 mg, Carton containing 4 blister packs of 14 tablets each,, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Ireland, NDC 0069-0469-03. EXPIRATION DATE: September 2021 June 2023; Lots 00019431, 00019542, 00019543, 00019544, 00020814, 00020815, 00020907, 00020965, 00021421, 00021422, 00021423, 00022136, 00022174, 00022175, 00022176, 00022177, 00022765, 00022766, 00023134, 00023135, 00023747, 00023748, DL3896, DL7779, DR2614, DX4576, DX5870, DX5871, DX5872, DX5873, DX7805, DY6078, DY7060, DY9367, DY9473, DY9475, DY9476, DY9505, EC5910, EC5913, EE9391, EF2346, EM4805, EM4807, EN2005, ET1601, ET1605, ET1606 EXPIRATION DATE: September 2021 December 2023 | — | — |
What to do — step by step
Check Product Details
Look for the NDC number 0069-0468-56 and specific lots listed in the recall notice.
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 47 days 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-0809-2021 (August 13, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0809-2021 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.