Gilenya recall in Canada: Risk of congenital malformations
In plain language
This recall involves Gilenya (fingolimod) capsules sold in Canada. It's being recalled because it may cause congenital malformations if used during pregnancy. Women of childbearing potential should discuss this risk with their healthcare provider and use effective contraception.
What to do
- Stop using the product immediately.
- Discuss the risks with your healthcare professional.
- Use effective contraception if you are a woman of childbearing potential.
- Do not plan a pregnancy while taking Gilenya or for 2 months after stopping.
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Affected products
Gilenya, Fingolimod capsules
Generic Fingolimod capsules
Why this matters
Risk of congenital malformations
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.
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?
Risk of congenital malformations
What should consumers do?
Stop using the product immediately. Discuss the risks with your healthcare professional. Use effective contraception if you are a woman of childbearing potential. Do not plan a pregnancy while taking Gilenya or for 2 months after stopping.
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. Risk of congenital malformations
When was this product recalled?
This product was recalled on December 19, 2019.
Is the Gilenya brand affected by this recall?
Yes, Gilenya products are affected by this recall. This recall involves Gilenya (fingolimod) capsules sold in Canada. It's being recalled because it may cause congenital malformations if used during pregnancy. Women of childbearing potential should discuss this risk with their healthcare provider and use effective contraception.