CHAMPIX (varenicline) recall in Canada: potential cancer risk
In plain language
This recall involves specific lots of CHAMPIX (varenicline) sold in Canada. It's being recalled because of a nitrosamine impurity that may increase cancer risk with long-term use. Patients should continue taking their medication as prescribed and consult their healthcare provider with concerns.
What to do
- Continue taking your medication as prescribed.
- Do not return medication to the pharmacy.
- Contact your healthcare provider if you have concerns.
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Affected products
CHAMPIX (varenicline) 0.5 mg and 1 mg Tablet, Kit
Lot: 00019062, 00020451, 00020452
Date codes: 2021-08, 2021-12, 2022-01
CHAMPIX (varenicline) 0.5 mg Tablet
Lot: ED7397
Date codes: 2022-05
CHAMPIX (varenicline) 1 mg Tablet
Lot: 00020013
Date codes: 2021-12
Why this matters
Potential increased cancer risk
Do I have this product?
This recall only applies to specific products. Follow the steps below to check.
- 1
Check the product name
Make sure your product name matches one of the affected products listed above.
- 2
Check the date code
Date codes are usually printed near the best-before date or on the packaging seam.
Affected date codes: 2021-08, 2021-12, 2022-01, 2022-05
- 3
Check the lot number
Lot numbers identify specific production batches.
Affected lots: 00019062, 00020013, 00020451, 00020452, ED7397
If your product matches one or more of the details above, it may be affected by this recall.
If your product does not match these details, it is not affected by this recall.
When in doubt, always check the official notice.
Frequently Asked Questions
Why was this product recalled?
Potential increased cancer risk
What should consumers do?
Continue taking your medication as prescribed. Do not return medication to the pharmacy. Contact your healthcare provider if you have concerns.
Where was the product sold?
This product was sold in Canada. For specific retailers or distribution areas, please check the official recall notice linked on this page.
Is there a health risk?
Yes, there may be a health risk. Potential increased cancer risk
When was this product recalled?
This product was recalled on June 30, 2021.
Is the CHAMPIX brand affected by this recall?
Yes, CHAMPIX products are affected by this recall. This recall involves specific lots of CHAMPIX (varenicline) sold in Canada. It's being recalled because of a nitrosamine impurity that may increase cancer risk with long-term use. Patients should continue taking their medication as prescribed and consult their healthcare provider with concerns.