The Recall Desk
ModerateFDA (Drugs)·D-0811-2021·Announced 2021-09-29

Chantix (Varenicline) Tablets Recalled for Impurity Above FDA Limits

Pfizer is recalling Chantix (varenicline) 1 mg tablets distributed nationwide due to the presence of N-nitroso-varenicline impurity above the FDA's acceptable interim intake limit. Affected lots have expiration dates from September 2021 to December 2023.

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. The source text does not report any illnesses, hospitalizations, injuries, or deaths. The impurity is above the FDA's acceptable interim intake limit, making this a precautionary recall rather than a confirmed hazard with reported harm.

Plain-English summary

Pfizer Inc. is recalling Chantix (varenicline) tablets 1 mg nationwide. The recall was initiated due to the presence of the N-nitroso-varenicline impurity in the product at levels above the FDA's acceptable interim acceptable intake limit. This is a Current Good Manufacturing Practice (CGMP) deviation.

The affected product is Chantix 1 mg tablets in cartons containing 4 blister packs of 14 tablets each, manufactured in Ireland with NDC 0069-0469-03. Multiple lot numbers are affected, with expiration dates ranging from September 2021 to December 2023.

Consumers who have obtained affected lots of this prescription medication should contact their healthcare provider or pharmacist for guidance. Patients should not stop taking their medication without consulting their doctor, as this could affect smoking cessation treatment.

The recalled product

Product
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
Manufacturer
Pfizer Inc.
Category
Drug — Prescription Tablet
Hazard
  • impurity-above-limit
  • cgmp-deviation

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 (20)

  • Lots 00019431
  • 00019542
  • 00019543
  • 00019544
  • 00020814
  • 00020815
  • 00020907
  • 00020965
  • 00021421
  • 00021422
  • 00021423
  • 00022136
  • 00022174
  • 00022175
  • 00022176
  • 00022177
  • 00022765
  • 00022766
  • 00023134
  • 00023135

Distribution

Distributed nationwide across the United States.

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