Health Product InfoWatch: September 2026

Contents

• Monthly recap of health product safety information
  • BONKY Injection, 1 mcg/mL Calcitriol
  • Central nervous system stimulants
  • Domperidone-containing products
  • Lactated Ringer's Injection USP
  • New Roots Herbal Probiotic Intensity
  • Teva-Pregabalin 150 mg
  • Unauthorized health products
• 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 August 2026 by Health Canada.

BONKY Injection, 1 mcg/mL Calcitriol

Due to a shortage of Calcitriol Injection USP, 1 mcg/mL, and given the medical necessity and the need to maintain continuity of supply in Canada, Health Canada has authorized the exceptional, temporary importation and sale of South Korean-authorized BONKY Injection, 1 mcg/mL Calcitriol, with Korean-only labels to mitigate the shortage. Healthcare professionals should be aware that there are differences between the South Korean-authorized and Canadian-authorized products.

Health Product Risk Communication: BONKY Injection, 1 mcg/mL Calcitriol

Central nervous system stimulants

This safety review evaluated the risk of weight loss associated with the off-label use of central nervous system (CNS) stimulants (amphetamine-, dextroamphetamine sulfate-, lisdexamfetamine dimesylate-, mixed salts amphetamine-, and methylphenidate hydrochloride-containing products) for attention-deficit/hyperactivity disorder (ADHD) in children under 6 years of age. Health Canada’s review found a possible increased risk of weight loss in children under 6 years of age compared to older children taking the same dose of CNS stimulants. Health Canada will work with the manufacturers to update the safety information in the Canadian product monograph for all CNS stimulants for ADHD.

Summary Safety Review: Central nervous system stimulants

Domperidone-containing products

This safety review evaluated the risk of episodes of severe hypertension in patients with pheochromocytoma associated with the use of domperidone-containing products. Health Canada’s review did not find sufficient evidence to establish a definite link. Health Canada will continue to monitor the safety of domperidone.

Summary Safety Review: Domperidone-containing products

Lactated Ringer's Injection USP

B. Braun Medical Inc. recalled 1 lot of Lactated Ringer's Injection USP due to the presence of particulate matter in the affected lot.

Type I drug recall: Lactated Ringer's Injection USP

New Roots Herbal Probiotic Intensity

New Roots Herbal Inc. recalled 1 lot of Probiotic Intensity because the outer box of the 30-count bottles incorrectly states that the product contains no dairy. The product contains bovine colostrum, which is a dairy ingredient, and may pose serious health risks to people with a severe dairy allergy.

Advisory: New Roots Herbal Probiotic Intensity

Teva-Pregabalin 150 mg

Teva Canada Ltd. recalled 2 lots of Teva-Pregabalin 150 mg capsules after routine testing identified that some capsules may be contaminated with the drug sertraline. Patients with a hypersensitivity or allergy to sertraline could experience side effects or have a serious allergic reaction, including an anaphylactic reaction, even at a low exposure.

Advisory: Teva-Pregabalin 150 mg

Unauthorized health products

Health Canada advised Canadians about various unauthorized health products being sold at retail locations across Canada or online that may pose serious health risks.

• Advisory: Unauthorized drugs seized from Rabais 4Saisons Inc. in Montreal, QC
• Advisory: Unauthorized injectable health products sold online and seized from Dyosa Beauty & Wellness Lounge in Hamilton, ON
• Type I recall: Twins Herbal Products: Undeclared prescription drug (sildenafil)

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