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

OTTAWA, ON , Sept. 25, 2026 /CNW/ -

Summary

Admelog 100 IU/mL – box of 5 cartridges

Admelog SoloSTAR 100 IU/mL – box of 5 pens

Apidra SoloSTAR 100 IU/mL – box of 5 pens

Lantus SoloSTAR 100 IU/mL – box of 5 pens

Toujeo DoubleSTAR 300 IU/mL – 1 pen (sample)

Toujeo DoubleSTAR 300 IU/mL – box of 3 pens

Toujeo SoloSTAR 300 IU/mL – 1 pen (sample)

Toujeo SoloSTAR 300 IU/mL – box of 3 pens

Toujeo SoloSTAR 300 IU/mL – box of 5 pens

Trurapi 100 IU/mL – box of 5 cartridges

Trurapi SoloSTAR 100 IU/mL – box of 5 pens

• Product: Certain insulin pens and cartridges manufactured by Sanofi-Aventis Canada Inc shipped on specific dates in July and August, 2026
• Issue: Health products – Product quality
• What to do: If your product is labelled with a lot number listed in the table, contact the place where you obtained the product to determine if your specific unit is affected. Only certain units within these lots are being recalled. If your product is affected, or if you are unsure, do not use it. Return it for a 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.   

Affected products

Name	DIN	Lot	Expiry
Admelog 100 IU/mL – box of 5 cartridges	02469898	5F044A 6F007A	11/2028 12/2028
Admelog SoloSTAR 100 IU/mL – box of 5 pens	02469871	6F755A 6F756A 6F757A	01/2029 02/2029 02/2029
Apidra SoloSTAR 100 IU/mL – box of 5 pens	02294346	6F957A	02/2028
Lantus SoloSTAR 100 IU/mL – box of 5 pens	02294338	6F0565A	10/2028
Toujeo DoubleSTAR 300 IU/mL – 1 pen (sample)	02493373	5F037A	04/2027
Toujeo DoubleSTAR 300 IU/mL – box of 3 pens	02493373	6F055A	09/2027
Toujeo SoloSTAR 300 IU/mL – 1 pen (sample)	02441829	4F284A	03/2027
Toujeo SoloSTAR 300 IU/mL – box of 3 pens	02441829	6F663A	08/2028
Toujeo SoloSTAR 300 IU/mL – box of 5 pens	02441829	6F680A	08/2028
Trurapi 100 IU/mL – box of 5 cartridges	02506564	6F029A 6F029B	07/2028 07/2028
Trurapi SoloSTAR 100 IU/mL – box of 5 pens	02506572	6F387A 6F403A	06/2028 07/2028

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.

Additional Information
>Background
Depth of recall: Retailers
>Details
Alert / recall type: Public Advisory
Category: Health products – Drugs
Published by: Health Canada
Distribution: National
Recall class: Type I
Company:
Sanofi-Aventis Canada Inc.
1755 Steeles Avenue West
Toronto, Ontario, M2R 3T4
1-800-265-7927

Également disponible en français

SOURCE Health Canada (HC)

Media Enquiries: Health Canada, [phone], [email protected]; Public Enquiries: [phone], 1-866 225-0709, [email protected]