RecallGuide.ca
    Health productsUpdated Jan 3, 2026ESBRIETOfficial source

    ESBRIET (pirfenidone) recall in Canada: Risk of drug-induced liver injury

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    In plain language

    This recall involves ESBRIET (pirfenidone) hard capsules and film-coated tablets sold in Canada. It's being recalled because it may cause drug-induced liver injury. Stop using the product and follow the return/repair steps in the official notice.

    What to do

    • Stop using the product immediately.
    • Talk to your healthcare professional if you have questions or concerns.
    • Seek immediate medical attention if you experience signs of liver injury.

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    Affected products

    • ESBRIET, pirfenidone hard capsules (267 mg)

    • ESBRIET, pirfenidone film-coated tablets (267 mg and 801 mg)

    Why this matters

    Drug-induced liver injury

    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?

    Drug-induced liver injury

    What should consumers do?

    Stop using the product immediately. Talk to your healthcare professional if you have questions or concerns. Seek immediate medical attention if you experience signs of liver injury.

    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. Drug-induced liver injury

    When was this product recalled?

    This product was recalled on September 14, 2020.

    Is the ESBRIET brand affected by this recall?

    Yes, ESBRIET products are affected by this recall. This recall involves ESBRIET (pirfenidone) hard capsules and film-coated tablets sold in Canada. It's being recalled because it may cause drug-induced liver injury. Stop using the product and follow the return/repair steps in the official notice.