Dr. Waserman on Allerjectvoluntary recall


What should Canadian consumers do if they have Allerject?

  • Canadian customers are instructed to immediately return all Allerject® devices to their local pharmacy.
  • Previous recommendations to limit the number of devices that can be replaced for an alternate auto-injector are now removed as a result of the announcement that supply an alternative product is sufficient to satisfy the demand.
  • All Allerject® epinephrine auto-injectors returned by patients to their pharmacist with an expiry date between October 2015 and December 2016 inclusively continue to be eligible for replacement at no cost to the patient.
If you have additional questions about this recall, you can contact the Allerject Call Center at 1 855-405-4321. If your pharmacist has specific questions relating to product return logistics, they should contact Sanofi Customer Service at 1-800-265-7927.

Is a prescription required to receive a replacement for my Allerject?

No prescription is required to receive a replacement epinephrine auto-injector.

Will patients have to pay for their replacement medication?

Sanofi is collaborating with retail pharmacy chains and pharmacists to ensure patients receive an alternate device at no cost to the patient.

What drug can be substituted as the replacement for Allerject?

EpiPen is the only epinephrine auto-injector currently available in Canada.*

*Twinject and Anapen are approved in Canada but not currently marketed.

What is the potential or theoretical risk if the recalled product is administered to patients?

There is no risk associated with the drug itself, but there is an issue with the device that may potentially affect delivery of the required amount of epinephrine. If a patient experiencing a serious allergic reaction (i.e. anaphylaxis) did not receive the intended dose, there could be significant health consequences, including death because anaphylaxis is a potentially life threatening condition

You say this is a voluntary recall, but did Health Canada advise you to recall Allerject?

During a routine manufacturing quality review, issues with the Allerject device were discovered at a contract manufacturer that may potentially affect the delivery of the required amount of drug. As a precautionary measure and with the knowledge of Health Canada and the FDA, Sanofi issued a voluntary Type I (Class I in the US) recall of all Allerject and Auvi-Q.

Have you alerted healthcare professionals?

Yes, we are actively communicating with healthcare professionals.

What should a patient do if the Allerject product they have fails to work?

Call 911 and immediately seek emergency medical services, in accordance with current product labelling. Any event that may be related to the use of this product should be reported either to Sanofi Canada or to MedEffect Canada’s website.

Do you expect to ultimately reintroduce this product in Canada? If so, when?

Sanofi’s priority and focus is to ensure patient safety. The company has instructed its contract manufacturer to temporarily discontinue manufacturing and for all distribution to cease until all product issues are resolved. We will continue to communicate the status of Allerject availability in a timely manner.

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Allerject epineprine auto-injection device

Allerject® is the first epinephrine auto-injection device with voice guided instructions.

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Latest News


June 17, 2015

Sanofi Canada issues voluntary recall of 2 lots of Allerject (0.15 mg / 0.15 mL) pediatric epinephrine injection distributed after June 1.
Please read the press release here.

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