Hand sanitizers labelled as ‘Anti-Microbe’ being recalled, may pose health risks: federal government

Health Canada says Atoms F.D. Inc. is recalling various 0.3% benzalkonium chloride hand sanitizers labelled as “Anti-Microbe” because they contain a higher concentration of benzalkonium chloride than permitted for personal, or home, use and may pose health risks, particularly to children up to 12 years of age.

Sanitizers with the Drug Identification Number (DIN) 02248351 are also included in the recall.

According to the federal government, products containing 0.3% benzalkonium chloride should be labelled for adult use in an industrial setting only. The affected products are not appropriately labelled with this information. 

Health Canada is aware that some products were distributed to various schools in Quebec, for use by children. The products were also sold online and in stores to the general public, mainly in Ontario and Quebec. 

Benzalkonium chloride cannot exceed a 0.15% concentration in hand sanitizers intended for personal or domestic use. Benzalkonium chloride is primarily used as a preservative and antimicrobial agent. In Canada, it is a known active ingredient in hard surface disinfectants and hand sanitizers. 

Health Canada says the frequent, daily use of hand sanitizers containing 0.3% benzalkonium chloride can cause red, itchy, dry or scaly skin in susceptible people. In some cases, peeling, swelling or blistering can occur. In rare cases, an allergic reaction can happen and can be serious. Signs of an allergic reaction include rash and hives; swelling of the mouth, face, lips, tongue or throat; chest or throat tightness; and wheezing or trouble breathing. 

Young children, adolescents, and people with skin conditions like eczema are particularly at risk of side effects involving frequent use.

For a full list of affected products, sold under various product and company names in various sizes and packaging formats, click here.

Health Canada has directed the license holder, Atoms F.D. Inc., to recall the affected products from the market, and to correct the labelling issue by ensuring that products are clearly labelled “For industrial use only” and “Keep out of reach of children,” as per their market authorization. Health Canada is monitoring the recall.