Chantix (Pfizer) – Impurity Risk (2021)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Pfizer Inc.
Lot Codes / Batch Numbers
Lots, CY6861, DM9007, DM9008, EN5725, EN8362, EN8467 EXPIRATION DATE: January 2022 - May 2023
Products Sold
Lots , CY6861, DM9007, DM9008, EN5725, EN8362, EN8467 EXPIRATION DATE: January 2022 - May 2023
Pfizer Inc. is recalling Chantix (varenicline) tablets 0.5mg, 56 Tablets, Rx only, Distributed by Pfizer Labs, Division of P due to CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026