The Recall Desk
ModerateFDA (Drugs)·D-0808-2021·Announced 2021-09-29

Chantix Varenicline Tablets Recalled for Nitroso Impurity

Pfizer is recalling Chantix (varenicline) tablets nationwide due to the presence of N-nitroso-varenicline impurity above FDA's acceptable interim intake limit, a manufacturing deviation.

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: The recall is an FDA Class II classification with a manufacturing deviation (CGMP non-compliance) involving an impurity above acceptable limits. No illnesses or injuries have been reported in the source text, making this a precautionary recall typical of moderate severity.

Plain-English summary

Pfizer Inc. is recalling Chantix (varenicline) tablets 0.5 mg/1 mg, 56-tablet packages (NDC 00069-0471-03) distributed nationwide. The product is made in Ireland and distributed by Pfizer Labs.

The recall was initiated because certain lots contain the N-nitroso-varenicline impurity at levels exceeding FDA's acceptable interim intake limit. This is a current good manufacturing practices (CGMP) deviation.

The affected lots are: 00018522, 00018523, 00018739, 00018740, 00020231, 00020232, 00020357, 00020358, 00020716, 00020813, 00021288, 00021289, 00021420, 00021687, 00021688, 00021788, 00021789, 00021790, 00021791, 00021792, 00022819, 00022851, 00023136, 00023137, 00023190, 00023448, DM0275, DM0276, DM0277, DY4470, EC5911, EC5912, ED6814, ET1600, ET1603, ET1607, ET1609, ET1611, with expiration dates between August 2021 and January 2023.

Patients taking affected doses should consult their healthcare provider about whether to continue use or switch to an alternative product. Do not discontinue smoking cessation treatment without medical guidance.

The recalled product

Product
Chantix (varenicline) tablets 0.5mg/1mg, 56 Tablets, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Ireland, NDC 00069-0471-03. carton containing one blister pack of 11 0.5 mg tablets and one blister pack containing 42.1 mg tablets.
Manufacturer
Pfizer Inc.
Category
Drug — Oral tablet
Hazard
  • impurity-nitroso-compound
  • 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 00018522
  • 00018523
  • 00018739
  • 00018740
  • 00020231
  • 00020232
  • 00020357
  • 00020358
  • 00020716
  • 00020813
  • 00021288
  • 00021289
  • 00021420
  • 00021687
  • 00021688
  • 00021788
  • 00021789
  • 00021790
  • 00021791
  • 00021792

Distribution

Distributed nationwide across the United States.

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