RecallGuide.ca
    Health productsUpdated Jan 3, 2026ITOVEBIOfficial source

    ITOVEBI (inavolisib) recall in Canada: Risk of life-threatening ketoacidosis

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    In plain language

    This recall involves ITOVEBI (inavolisib) tablets, 3 mg and 9 mg, sold in Canada. It's being recalled because it may cause life-threatening ketoacidosis, especially in diabetic patients. Patients should consult their healthcare professional if they have questions or concerns about this information.

    What to do

    • Stop taking the product and seek immediate medical attention if you experience signs of ketoacidosis.
    • Consult with your healthcare professional if you have any questions or concerns.
    • Ensure blood glucose levels are well-controlled and stable before and during treatment.

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    Affected products

    • ITOVEBI (inavolisib) tablets

    Why this matters

    Risk of life-threatening ketoacidosis

    Do I have this product?

    This recall only applies to specific products. Follow the steps below to check.

    1. 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.

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    Frequently Asked Questions

    Why was this product recalled?

    Risk of life-threatening ketoacidosis

    What should consumers do?

    Stop taking the product and seek immediate medical attention if you experience signs of ketoacidosis. Consult with your healthcare professional if you have any questions or concerns. Ensure blood glucose levels are well-controlled and stable before and during treatment.

    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 life-threatening ketoacidosis

    When was this product recalled?

    This product was recalled on October 9, 2025.

    Is the ITOVEBI brand affected by this recall?

    Yes, ITOVEBI products are affected by this recall. This recall involves ITOVEBI (inavolisib) tablets, 3 mg and 9 mg, sold in Canada. It's being recalled because it may cause life-threatening ketoacidosis, especially in diabetic patients. Patients should consult their healthcare professional if they have questions or concerns about this information.