BENLYSTA recall in Canada: Increased risk of serious depression
In plain language
This recall involves BENLYSTA (belimumab) for intravenous infusion and subcutaneous injection sold in Canada. It's being recalled because of an increased risk of serious depression, suicidal thoughts or behavior, or self-injury. Stop using the product and follow the return/repair steps in the official notice.
What to do
- Stop using the product immediately.
- Contact your healthcare provider if you experience new or worsening depression, suicidal thoughts or behavior, or self-injury.
- Discuss any concerns with your healthcare professional.
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Affected products
BENLYSTA (belimumab), lyophilized powder for intravenous infusion, 120 mg and 400 mg vials
BENLYSTA (belimumab), solution for subcutaneous injection, 200 mg/mL
Why this matters
Increased risk of serious depression, suicidal ideation or behaviour, or self-injury
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?
Increased risk of serious depression, suicidal ideation or behaviour, or self-injury
What should consumers do?
Stop using the product immediately. Contact your healthcare provider if you experience new or worsening depression, suicidal thoughts or behavior, or self-injury. Discuss any concerns with your healthcare professional.
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. Increased risk of serious depression, suicidal ideation or behaviour, or self-injury
When was this product recalled?
This product was recalled on April 4, 2019.
Is the BENLYSTA brand affected by this recall?
Yes, BENLYSTA products are affected by this recall. This recall involves BENLYSTA (belimumab) for intravenous infusion and subcutaneous injection sold in Canada. It's being recalled because of an increased risk of serious depression, suicidal thoughts or behavior, or self-injury. Stop using the product and follow the return/repair steps in the official notice.