Pfizer Chantix Tablets Recalled for N-nitroso-varenicline Impurity
Pfizer is recalling Chantix (varenicline tartrate) 0.5mg tablets nationwide due to the presence of N-nitroso-varenicline impurity above FDA's acceptable interim intake limit. The recall affects 59,232 bottles.
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 (CGMP violation) with a chemical impurity present above acceptable limits. No reported illnesses or injuries are stated in the source text; the hazard is detection of the impurity itself during quality control, making this a precautionary recall typical of Class II classifications.
Plain-English summary
Pfizer Inc. is recalling Chantix (varenicline tartrate) 0.5mg tablets, 56-tablet bottles (NDC 0069-0468-56), manufactured in Ireland and distributed nationwide. The recall was initiated due to the presence of N-nitroso-varenicline impurity in the product that exceeds FDA's acceptable interim acceptable intake limit.
The affected lots are 00019213 (expiration 31 January 2022) and EC6994 (expiration 31 May 2023). A total of 59,232 bottles are involved in this recall.
Consumers who have this product should not discontinue their medication without consulting their healthcare provider. Patients should contact their healthcare provider or pharmacist for guidance on obtaining an alternative supply of varenicline or another smoking-cessation medication.
The recalled product
- Product
- CHANTIX (VARENICLINE TARTRATE)
- Brand
- CHANTIX
- Manufacturer
- Pfizer Inc.
- Affected units
- 59,232
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 (4)
- Lots 00019213
- Exp 31 Jan 2022 & EC6994
- Exp May 31
- 2023
UPCs (3)
- 0300690469560
- 0300690468563
- 0300690471280
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 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 3 products in this recall →Related recalls
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FDA (Drugs) · 2021-09-29
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FDA (Drugs) · 2021-09-29
- 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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