Health Product InfoWatch: October 2026
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Health Products and Food Branch
Marketed Health Products Directorate
Health Product InfoWatch Editorial Team
ISSN: 2368-8025
Cat.: H167-1E-PDF
Pub.: 260000
Contents
- Monthly recap of health product safety information
- Announcement
- New health product safety information
- Scope
- Reporting adverse reactions
- Helpful links
- Contact us
Monthly recap of health product safety information
The following is a list of health product advisories, type I drug recalls, and summaries of completed safety reviews published in September 2026 by Health Canada.
Cabergoline-containing products
This safety review evaluated the risk of serious hypertension, myocardial infarction, stroke and seizure in postpartum women associated with the use of cabergoline-containing products. Health Canada's review found a possible link. Health Canada will work with the manufacturers to update the product safety information in the Canadian product monograph for all cabergoline-containing products to include these risks.
Summary Safety Review: Cabergoline-containing products
Insulin pens and cartridges manufactured by Sanofi-Aventis Canada Inc.
Sanofi-Aventis Canada Inc. recalled certain units of 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. Only a limited number of units in each lot are being recalled.
Advisory: Insulin pens and cartridges manufactured by Sanofi-Aventis Canada Inc.
Novo-Gesic Forte 500 mg (acetaminophen)
Teva Canada Limited recalled 1 lot of the non-prescription drug Novo-Gesic Forte 500 mg (acetaminophen) due to the potential presence of phenolic resin or epoxy which, if ingested, may cause injury to the digestive system. The affected product was supplied to pharmacies in 1,000-count bottles and was dispensed to patients in smaller quantities.
Advisory: Novo-Gesic Forte 500 mg (acetaminophen)
Sarclisa (isatuximab)
Nine units from the affected lot of Sarclisa single-use vials were recalled from 3 locations in Nova Scotia as they may have been frozen during shipping.
Type I drug recall: Sarclisa (isatuximab)
Surgical mesh used for hernia repair
Since 2009, Health Canada has completed several safety reviews on postsurgical complications associated with surgical mesh used for hernia repair. Ongoing patient reports of postsurgical complications prompted an updated safety review. Results of the current review align with previous findings, global reports and literature. Surgical mesh for hernia repair reduces recurrence, and its overall complication rate remains comparable to non-mesh repairs. The overall benefits of using surgical mesh for hernia repair continue to outweigh the risks. Health Canada will continue to monitor the safety of surgical mesh devices.
Summary Safety Review: Surgical mesh used for hernia repair
Tzield (teplizumab)
Serious and life-threatening cases of viral reactivation, including Epstein-Barr virus and cytomegalovirus, have been reported with Tzield. Tzield is now contraindicated in patients with an active viral infection, any active serious infection, or who are immunocompromised. The Canadian product monograph for Tzield has been updated to include this safety information.
Health Product Risk Communication: Tzield (teplizumab)
Unauthorized health products
Health Canada advised Canadians about unauthorized health products being sold at retail locations across Canada or online that may pose serious health risks.
Advisory: Counterfeit Soprano laser hair removal and therapy devices
Announcement
#MedSafetyWeek 2026
Health Canada is joining the World Health Organization's annual #MedSafetyWeek social media campaign to raise awareness about the importance of reporting adverse reactions (ARs) to health products. The 2026 campaign will take place from November 2 to 8 with the theme "Side effects – don't ignore them, report them".
Adverse reactions contribute significantly to global morbidity and mortality. While health products undergo rigorous assessment before being authorized for sale, they are typically studied in a limited number of carefully selected individuals and for a relatively short period of time. Health product safety knowledge evolves over time. Some safety issues may only become evident after a product is used by a broader population, for a longer duration of time and/or in real-world settings.
Healthcare professionals play a vital role in identifying and reporting ARs. Reporting suspected ARs to Health Canada's Canada Vigilance Program helps strengthen the Department's post-market surveillance activities and supports the ongoing assessment of health product safety. These reports provide valuable information that helps ensure the benefits of health products continue to outweigh their risks.
Health Canada also contributes to global drug safety monitoring efforts by sharing information collected through AR reports with international partners, including the World Health Organization's Programme for International Drug Monitoring, the US Food and Drug Administration and the European Medicines Agency.
To learn more about the #MedSafetyWeek campaign, follow Health Canada's social media channels starting November 2, 2026:
New health product safety information
The following topic has been selected to raise awareness and encourage reporting of adverse reactions.
Notice of market authorization with conditions
A Notice of Compliance with Conditions (NOC/c) is a form of market authorization with conditions granted to a product on the basis of promising evidence of clinical effectiveness following review of the submission by Health Canada. Communicating a NOC/c is intended to raise awareness on the details of the drug and the type of authorization granted.
Healthcare professionals are encouraged to report to Health Canada any adverse reactions suspected of being associated with marketed health products, including drugs authorized under the NOC/c policy.
The content of these notices reflects current information at the time of publication. Conditions associated with the NOC/c will remain until they have been fulfilled and authorized by Health Canada. For the most up-to-date information, consult Health Canada's NOC database.
Hernexeos (zongertinib): Authorization with conditions
Health Canada has issued a Notice of Compliance, under the NOC/c policy, for Hernexeos (zongertinib), 60 mg oral tablets. Hernexeos is indicated for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer whose tumours have HER2 (ERBB2) tyrosine kinase domain activating mutations and who have received prior systemic therapy. Patients should be advised of the conditional market authorization for this indication.
For the complete prescribing information and information available for patients/caregivers, please consult the Hernexeos Canadian product monograph. The product monograph can be accessed through Health Canada's Drug Product Database, the Boehringer Ingelheim (Canada) Ltd. website or by contacting Boehringer Ingelheim (Canada) Ltd. at 1-800-263-5103, extension 84633. Contact the company for a copy of any references, attachments or enclosures.
Scope
This monthly publication is intended primarily for healthcare professionals and includes information on pharmaceuticals, biologics, medical devices, and natural health products. It provides a summary of key health product safety information published in the previous month by Health Canada, as well as a selection of new health product safety information meant to raise awareness. New information contained in this issue is not comprehensive but rather represents a selection of clinically relevant items warranting enhanced dissemination.
Reporting adverse reactions
Canada Vigilance Program
Telephone: 1-866-234-2345
Fax or mail: Form available on MedEffect Canada
For more information on how to report an adverse reaction, visit the Adverse Reaction and Medical Device Problem Reporting page.
Helpful links
- MedEffect™ Canada
- Recalls and Safety Alerts Database
- New Safety and Effectiveness Reviews
- Canada Vigilance Adverse Reaction Online Database
- Drug Product Database
- Medical Devices Active Licence Listing
- Licensed Natural Health Products Database
- The Drug and Health Product Portal
- Drug Shortages Canada
- Medical Device Shortages
- COVID-19 Vaccines and Treatments Portal
Contact us
Your comments are important to us. Let us know what you think by reaching us at:
infowatch-infovigilance@hc-sc.gc.ca
Health Product InfoWatch Editorial Team
Marketed Health Products Directorate
Health Canada
Address Locator 1906C
Ottawa, ON K1A 0K9