Pfizer recalls Chantix tablets for N-nitroso-varenicline impurity
Pfizer is recalling certain lots of Chantix (varenicline tartrate) 0.5mg tablets nationwide due to the presence of N-nitroso-varenicline impurity above FDA's acceptable interim intake limit.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving a manufacturing deviation with a chemical impurity above acceptable limits. The source text does not report any illnesses, injuries, or deaths, and the hazard is a quality/manufacturing issue rather than an acute health threat. This fits the "low-risk contamination" or precautionary recall profile, warranting a Moderate score.
Plain-English summary
Pfizer Inc. is recalling Chantix (varenicline tartrate) 0.5mg tablets, 56-tablet packages, with lot numbers CY6861, DM9007, DM9008, EN5725, EN8362, and EN8467, with expiration dates ranging from January 2022 to May 2023. The recall is nationwide and affects this prescription smoking-cessation medication distributed by Pfizer Labs in New York.
The reason for the recall is the presence of N-nitroso-varenicline impurity in the affected tablets at levels above FDA's acceptable interim intake limit. This is a manufacturing deviation from current Good Manufacturing Practice (CGMP) standards.
Patients currently taking affected lots of Chantix should consult their healthcare provider or pharmacist before discontinuing use. Consumers should check their medication to determine if it matches one of the recalled lot numbers and expiration dates. The product identification is NDC 0069-0468-56, and the drug was manufactured in Ireland.
The recalled product
- Product
- CHANTIX (VARENICLINE TARTRATE)
- Brand
- CHANTIX
- Manufacturer
- Pfizer Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- Lots
- CY6861
- DM9007
- DM9008
- EN5725
- EN8362
- EN8467 EXPIRATION DATE: January 2022 - May 2023
UPCs (3)
- 0300690469560
- 0300690468563
- 0300690471280
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Pfizer Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
Same brand · CHANTIX
- ModerateChantix Varenicline Tablets Recalled for N-Nitroso Impurity
FDA (Drugs) · 2021-09-29
- ModeratePfizer Chantix Tablets Recalled for N-nitroso-varenicline Impurity
FDA (Drugs) · 2021-08-11
- ModeratePfizer Chantix Tablets Recalled for Nitroso Impurity Above FDA Limit
FDA (Drugs) · 2021-08-11
- ModeratePfizer Chantix Tablets Recalled for N-Nitroso-Varenicline Impurity
FDA (Drugs) · 2021-08-11
- ModerateCardinal Health Recalls Chantix Tablets Due to Temperature Excursions
FDA (Drugs) · 2021-06-02
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