Health Canada Issues Type I Recall for Dantrium Intravenous Injection 2026
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Health Canada has classified a recall of Dantrium Intravenous (dantrolene sodium for injection) as Type I, after particulate matter was identified in affected lots of the product. The recall notice, published on October 19, 2026 under identification number RA-82808, names Knight Therapeutics Inc. as the recalling firm and confirms the action applies nationally across Canada.
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A Type I classification is the category assigned to the most serious recalls. For healthcare facilities that stock the injection, the notice is one to act on promptly.
Products Affected by This Recall
The recall covers a single product in three lots. Details from the Health Canada notice are below.
- Product: Dantrium Intravenous (Dantrolene sodium for injection)
- Brand and company: Knight Therapeutics Inc.
- Market authorization: DIN 01997572
- Dosage form: Powder for solution
- Strength: 20 mg/vial
- Lot numbers: 80681, 82413 and 91579
Any vial from these three lots is within the scope of the recall. Facilities should check lot numbers carefully against the list above.
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What Triggered the Recall
The stated reason is short and direct: the presence of particulate matter in the affected lots. Health Canada categorizes the issue as a contamination problem involving health products.
Particulate matter in an injectable medication is a quality defect, because the product is meant to be administered directly into the body. The notice does not describe the type or source of the particles, and it does not report any injuries or adverse reactions linked to the lots. Those details were not part of the published information.
Where the Product Was Distributed and Who Is Affected
Health Canada lists the distribution as national. The notice also states that the depth of the recall is healthcare establishments. In practical terms, this means the recall is directed at the facilities that hold and use the injection, rather than at consumers buying it over the counter.
The audience for the alert includes the general public, healthcare professionals and industry. Patients who have received this medication or who have questions about their care are advised to speak with their healthcare provider.
What Consumers and Healthcare Providers Should Do
Health Canada lists four steps in the notice:
- Consult your healthcare provider for any health concerns.
- Contact the recalling firm if you have any questions about the recall.
- Report any health product related side effects to Health Canada.
- Report any other health product safety complaints to Health Canada.
The notice does not spell out return or replacement instructions, so questions about those matters should go to the recalling firm. Knight Therapeutics Inc. is based at 100 boul. Alexis-Nihon, suite 600, Montreal, Quebec, H4M 2P2.
Facilities that have the affected lots on hand should identify the stock using the lot numbers and the DIN listed above. They should then follow the direction of the recalling firm and Health Canada.
Regulatory Response
Health Canada published the notice as a health product recall in the Health products – Drugs category. The page was first posted and last updated on October 19, 2026. The department classified the recall as Type I and assigned it identification number RA-82808.
The notice gives no further statement from Knight Therapeutics Inc. beyond naming it as the company involved. It also gives no timeline for corrective action, and it does not report how many vials were distributed. Health Canada generally publishes updates to recall notices on its Recalls and safety alerts website, and readers can subscribe there for email notifications about new and updated alerts.
Quick Facts
- Recall number: RA-82808
- Recall class: Type I
- Date published: October 19, 2026
- Distribution: National (Canada)
- Depth of recall: Healthcare establishments
- Issue: Presence of particulate matter
Anyone who has a health concern linked to this medication should contact a healthcare provider. Side effects and product complaints can be reported to Health Canada through the channels listed on the official recall page.
Official Source: View original notice on Health Canada →
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