HIZENTRA solution recalled due to appearance out of specification
Summary
Health Canada has issued a recall for the HIZENTRA solution due to an appearance out of specification in lot P100834477. The recall is classified as Type II, indicating a low risk to health. End users are advised to consult healthcare providers before discontinuing use.
What changed
Health Canada has announced a Type II recall for the HIZENTRA solution, specifically lot number P100834477, due to the product's appearance being out of specification. This recall affects end users and is being managed by CSL Behring Canada Inc. The identification number for this recall is RA-81796.
Healthcare providers and patients are advised to verify if their product is affected. Patients should consult their healthcare provider before discontinuing use of the affected product or if they have any health concerns. The recalling firm can be contacted for questions. Health Canada also requests reporting of any related side effects or safety complaints.
What to do next
- Verify if product is affected
- Consult healthcare provider prior to discontinuing use
- Report side effects or safety complaints to Health Canada
Archived snapshot
Mar 27, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Health product recall
HIZENTRA: The appearance is out of specification in the affected lot.
Brand(s)
Last updated
2026-03-26
Summary
Product HIZENTRA Issue Health products - Product safety What to do
Consult your healthcare provider prior to discontinuing use of the affected product, or for any health concerns.
Affected products
| Brand | Product Name | Market Authorization | Dosage Form | Strength | Lot |
|---|---|---|---|---|---|
| Hizentra | Hizentra | DIN 02463067 | Solution | Subcutaneous Immunoglobulin (Human) 20% Solution for injection (2g/10mL) | P100834477 |
Issue
The appearance is out of specification in the affected lot.
What you should do
- Verify if your product is affected.
- Consult your healthcare provider prior to discontinuing use of the affected product, or 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.
Additional information
Background
Depth of recall: End users
Details
Original published date:
2026-03-26
Alert / recall type Health product recall Category Health products - Drugs Companies
CSL Behring Canada, Inc.
55 Metcalfe Street, Suite 350,
Ottawa, ON
K1P 6L5
Published by Health Canada Audience General public Healthcare Industry Recall class Type II Recall date
2026-03-26
Identification number RA-81796
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Source
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