RecallGuide.ca
    Health productsUpdated Jan 3, 2026COMIRNATYOfficial source

    COMIRNATY vaccine recall in Canada: labelling issue

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    In plain language

    This recall involves COMIRNATY Original & Omicron BA.4/BA.5 Bivalent Vaccine for children 5 to less than 12 years of age. It's being recalled because some vials and cartons have English-only labels, missing Canadian-specific information. Healthcare professionals should pay close attention to labels to avoid medication errors.

    What to do

    • Stop using the product immediately.
    • Check model/serial numbers if provided.
    • Return, repair, or dispose of it as instructed.

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    Affected products

    Specific affected products are listed in the official notice.

    Why this matters

    Medication error due to labelling

    Do I have this product?

    This recall applies to specific products. Details are listed in the official notice.

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    Frequently Asked Questions

    Why was this product recalled?

    Medication error due to labelling

    What should consumers do?

    Stop using the product immediately. Check model/serial numbers if provided. Return, repair, or dispose of it as instructed.

    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. Medication error due to labelling

    When was this product recalled?

    This product was recalled on December 9, 2022.

    Is the COMIRNATY brand affected by this recall?

    Yes, COMIRNATY products are affected by this recall. This recall involves COMIRNATY Original & Omicron BA.4/BA.5 Bivalent Vaccine for children 5 to less than 12 years of age. It's being recalled because some vials and cartons have English-only labels, missing Canadian-specific information. Healthcare professionals should pay close attention to labels to avoid medication errors.