Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Chantix (varenicline) tablets 1 mg Recalled by Pfizer Inc. Due to CGMP Deviations: Presence of the N-nitroso-varenicline impurity above...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Pfizer Inc. directly.
Affected Products
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
Why Was This Recalled?
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Pfizer Inc.
Pfizer Inc. has 114 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report