Glatiramer acetate recall in Canada: Anaphylactic reaction risk
In plain language
This recall involves glatiramer acetate products, including Copaxone, Glatect, and Mylan glatiramer acetate injection, sold in Canada. It's being recalled because it may cause a severe allergic reaction called anaphylaxis. Stop using the product and follow the return/repair steps in the official notice.
What to do
- Stop using the product immediately if you experience anaphylactic symptoms.
- Seek immediate medical help by calling 9-1-1.
- Do not restart glatiramer acetate unless your healthcare provider identifies another cause for the reaction.
- Report any health product-related side effects to Health Canada.
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Affected products
Copaxone (glatiramer acetate) 20 mg/mL single-use pre-filled syringe
Copaxone (glatiramer acetate) 40 mg/mL single-use pre-filled syringe
Copaxone (glatiramer acetate) 40 mg/mL single-use pre-filled pens
Glatect (glatiramer acetate) 20 mg/mL single-use pre-filled syringe
Mylan glatiramer acetate injection 20 mg/mL single-use pre-filled syringe
Why this matters
Anaphylactic reaction 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.
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?
Anaphylactic reaction risk
What should consumers do?
Stop using the product immediately if you experience anaphylactic symptoms. Seek immediate medical help by calling 9-1-1. Do not restart glatiramer acetate unless your healthcare provider identifies another cause for the reaction. Report any health product-related side effects to Health Canada.
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. Anaphylactic reaction risk
When was this product recalled?
This product was recalled on August 21, 2025.
Is the Copaxone, Glatect, Mylan brand affected by this recall?
Yes, Copaxone, Glatect, Mylan products are affected by this recall. This recall involves glatiramer acetate products, including Copaxone, Glatect, and Mylan glatiramer acetate injection, sold in Canada. It's being recalled because it may cause a severe allergic reaction called anaphylaxis. Stop using the product and follow the return/repair steps in the official notice.