Sanofi-Aventis Canada recalls 1,043 insulin pens and cartridges over freezing risk

Sanofi-Aventis Canada Inc. is recalling certain insulin pens and cartridges from multiple lots because the units may have been frozen during shipping, Health Canada's recalls and safety alerts page said on Sept. 25, 2026.

Frozen insulin may have reduced effectiveness, and using compromised product may lead to high blood sugar, or hyperglycemia, the alert said. Only a limited number of units in each lot are affected, not the entire lot.

The affected units were shipped to approximately 80 pharmacies, clinics and hospitals across Canada on July 13, 14 and 15 and Aug. 10, 11, 12 and 13, 2026. In total, 1,043 units are affected, which is less than 1 per cent of the total number of units distributed.

Company contacts affected sites

Sanofi-Aventis Canada Inc. has informed the specific pharmacies, clinics and hospitals impacted by the recall, according to the alert.

Insulin is used to control high blood sugar in adults and children with diabetes. Unopened product should be kept in a refrigerator at 2°C to 8°C and should never be frozen, the alert said. Storage conditions for opened insulin vary by product, and the package insert has instructions.

Symptoms and oversight

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, nausea and vomiting, the alert said. 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, according to the alert.

Health Canada said it 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.