RecallGuide.ca
    Health productsUpdated Jan 3, 2026OrajelOfficial source

    Orajel recall in Canada: Precautionary recall for infants and children

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    In plain language

    This recall involves Orajel Regular Strength Gel For Teething and Orajel Extra Strength Gel For Nighttime sold in Canada. It's being recalled as a precautionary measure based on the US FDA's position regarding oral benzocaine products for infants and children under 2. Stop using the product and follow the return steps in the official notice.

    What to do

    • Stop using the product immediately.
    • Check the NPN and lot numbers if you have these products.
    • Dispose of the product as instructed by the official notice.

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    Affected products

    • Orajel Regular Strength Gel For Teething

      Lot: KK616101, KK625701, KK630801, KK705901, KK715801, KK728301, KK808501

    • Orajel Extra Strength Gel For Nighttime

      Lot: KK634001, KK708601, KK722701, KK736101

    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.

    2. 2

      Check the lot number

      Lot numbers identify specific production batches.

      Affected lots: KK616101, KK625701, KK630801, KK705901, KK715801, KK728301, KK808501, KK634001, KK708601, KK722701, KK736101

    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?

    This recall involves Orajel Regular Strength Gel For Teething and Orajel Extra Strength Gel For Nighttime sold in Canada. It's being recalled as a precautionary measure based on the US FDA's position regarding oral benzocaine products for infants and children under 2. Stop using the product and follow the return steps in the official notice.

    What should consumers do?

    Stop using the product immediately. Check the NPN and lot numbers if you have these products. Dispose of the product as instructed by the official notice.

    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?

    A potential safety risk has been identified with this product. Stop using it immediately and follow the instructions in the official recall notice.

    When was this product recalled?

    This product was recalled on May 29, 2018.

    Is the Orajel brand affected by this recall?

    Yes, Orajel products are affected by this recall. This recall involves Orajel Regular Strength Gel For Teething and Orajel Extra Strength Gel For Nighttime sold in Canada. It's being recalled as a precautionary measure based on the US FDA's position regarding oral benzocaine products for infants and children under 2. Stop using the product and follow the return steps in the official notice.