OTTAWA, ON, July 8, 2026 /CNW/ –
Summary
- Product: Omnitrope (5 mg/1.5 mL somatropin)
- Issue: Health products – Product quality
- What to do: Do not use the recalled product. Return it to your pharmacy for replacement and for proper disposal. If you or your child have used this product and experience any unusual symptoms, side effects, or have any health concerns, consult a healthcare professional.
Photos
Affected products
| Product | DIN | Lot | UPC | Expiry |
| Omnitrope (5 mg/1.5 mL somatropin) | 02325063 | PR7350 | 057513215742 | 2027-04-30 |
| Omnitrope (5 mg/1.5 mL somatropin) | 02325063 | PR7351 | 057513215759 | 2027-04-30 |
Issue
Sandoz Canada Inc. is recalling two lots of Omnitrope 5 mg/1.5 mL somatropin after receiving complaints of cracked and leaking glass cartridges. Cracked and leaking cartridges may lead to contamination and infection, and to lower doses than intended.
Omnitrope is a prescription drug that contains somatropin, a human growth hormone that is administered by subcutaneous injection (under the skin). Omnitrope is used to treat both adults and children with growth hormone deficiency, and to treat children who have not reached or maintained normal growth by the age of two years, or who have Turner syndrome.
Injecting contaminated Omnitrope subcutaneously may lead to local or systemic infection (i.e., near the injection site or throughout the body). Glass particles may cause local tissue irritation and may lead to local tissue infections or abscesses (pus-filled lumps). Lower doses of Omnitrope over a long period of time (weeks) may also reduce its effectiveness.
Health Canada is monitoring the company’s recall and investigation, including its implementation of corrective and preventive actions to prevent this issue from reoccurring, and will inform the public if new risks are identified.
What you should do
- If you have a recalled product, do not use it. Contact your pharmacy immediately for a replacement. Return the recalled product to your pharmacy for proper disposal.
- If you or your child have used this product and experience any unusual symptoms (e.g. persistent redness, swelling and/or pain at the injection site, fever) or have any other health concerns, consult a healthcare professional.
- Contact Sandoz Canada Inc. by calling toll-free at 1-800-343-8839 if you have questions about this recall.
- Report any health product-related side effects or complaints to Health Canada.
Additional Information
Depth of recall: Retailers
Alert / recall type: Public Advisory
Category: Health products – Biologic or vaccine
Published by: Health Canada
Distribution: National
Recall class: Type I
Également disponible en français
SOURCE Health Canada (HC)