Health Canada Issues Type I Recall for Limited Units of Multiple Sanofi Insulin Pens and Cartridges
Health Canada has issued a national Type I recall for 1,043 units from specified lots of Admelog, Apidra, Lantus, Toujeo and Trurapi that may have frozen during shipping. Only certain units within the listed lots are affected, so pharmacies should use Sanofi’s shipment-level notification rather than treating every unit in a listed lot as recalled.
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Health Canada has posted a national Type I recall involving limited units of several Sanofi insulin pens and cartridges. The affected units may have been frozen during shipping, which can reduce insulin effectiveness and increase the risk of hyperglycemia.
Important scope detail: the recall does not apply to every unit from the listed lots. Sanofi identified 1,043 affected units—less than 1% of the units distributed—and notified approximately 80 pharmacies, clinics and hospitals that received them on July 13–15 or August 10–13, 2026.
Affected products and lots
| Product / presentation | DIN | Lots |
|---|---|---|
| Admelog 100 units/mL, 5 cartridges | 02469898 | 5F044A, 6F007A |
| Admelog SoloSTAR 100 units/mL, 5 pens | 02469871 | 6F755A, 6F756A, 6F757A |
| Apidra SoloSTAR 100 units/mL, 5 pens | 02294346 | 6F957A |
| Lantus SoloSTAR 100 units/mL, 5 pens | 02294338 | 6F0565A |
| Toujeo DoubleSTAR 300 units/mL, sample pen or 3 pens | 02493373 | 5F037A, 6F055A |
| Toujeo SoloSTAR 300 units/mL, sample pen, 3 pens or 5 pens | 02441829 | 4F284A, 6F663A, 6F680A |
| Trurapi 100 units/mL, 5 cartridges | 02506564 | 6F029A, 6F029B |
| Trurapi SoloSTAR 100 units/mL, 5 pens | 02506572 | 6F387A, 6F403A |
A lot number match alone does not establish that a unit is recalled. Pharmacies and patients should contact the location from which the insulin was obtained to determine whether the specific unit is affected. A confirmed or uncertain affected unit should not be used and should be returned for replacement or disposal.
Patients who may have used an affected unit should monitor blood glucose more closely and seek medical advice for unusual readings, symptoms of hyperglycemia or other concerns. Sanofi can be reached at 1-800-265-7927.
Practice guidance for pharmacists
- Review Sanofi’s location-specific notification and local receiving records; do not assume that every unit in a listed lot is affected.
- Quarantine confirmed or potentially affected units, segregate usable stock, and contact Sanofi for shipment-level verification and replacement instructions.
- Reconcile dispensing records against the identified shipment scope and follow local recall procedures when contacting affected patients.
- Advise patients not to interrupt insulin therapy without a replacement plan; reinforce glucose monitoring and the signs and symptoms of hyperglycemia.
- Document inventory reconciliation and patient follow-up, and report suspected adverse reactions or product-quality complaints to Health Canada.
References
- Sanofi-Aventis Canada Inc. recalling certain insulin pens and cartridges — Health Canada, September 25, 2026
