Sanofi-Aventis Canada Inc. recalling certain insulin pens and cartridges

Issue

Sanofi-Aventis Canada Inc. is recalling certain insulin pens and cartridges from multiple lots as they may have been frozen during shipping. Insulin products that have been frozen may have reduced effectiveness. Using compromised insulin products may lead to high blood sugar (hyperglycemia). Only a limited number of units in each lot are being recalled, not the entire lot. The affected units were shipped to approximately 80 pharmacies, clinics and hospitals across Canada on July 13, 14, 15, and August 10, 11, 12, 13, 2026. In total, only 1,043 units are affected, which is less than 1% of the total number of units distributed. Sanofi-Aventis Canada Inc. has informed the specific pharmacies, clinics and hospitals impacted by this recall. Insulin is used to control high blood sugar in adults and children with diabetes. While unopened product should be kept in a refrigerator at 2°C to 8°C, it should never be frozen. Storage conditions for opened insulin (in use) vary by product. Please refer to the package insert for instructions. Warning symptoms of high blood sugar include: frequent urination, feeling thirsty, feeling hungry, dry mouth, blurred vision, tiredness or sleepiness, breath that smells fruity or like acetone (nail polish remover), nausea and vomiting. High blood sugar may only be seen by measuring blood sugar levels, and may not display any physical signs. Prolonged or severely high blood sugar may lead to serious health consequences requiring medical treatment, such as confusion, loss of consciousness, seizures, coma, and in rare situations, death. Health Canada is monitoring the company's recall and investigation, including its implementation of corrective and preventive actions, and will inform the public if new risks are identified.

What you should do

• Only a limited number of units within the listed lots are affected by this recall. Do not assume your product is affected solely because the lot number appears in the table.
• If your product is labelled with a lot number listed on the table, contact the place where you obtained the product to determine if your specific unit is affected.
• If your product is affected, or if you are unsure, do not use it. Return it to the place where you obtained the product for replacement and proper disposal.
• If you have used an affected product, monitor your blood sugar more closely. If you experience any unusual symptoms or have any other health concerns, consult a healthcare professional.
• Contact Sanofi-Aventis Canada Inc. by calling toll-free at 1-800-265-7927 if you have questions about this recall.
• Report any health product-related side effects or complaints to Health Canada.