Health Canada Recall Guidance: Updated Drug, Natural Health Product, and Biocide Recall Guide (GUI-0039): What You Need to Know 

In late 2024, Health Canada released an updated version of its Recall Guide (GUI-0039) to include biocides alongside drugs and natural health products (NHPs). This updated guidance outlines the regulatory requirements for product recalls in Canada, the roles and responsibilities of supply chain stakeholders, and the importance of maintaining robust recall systems for health product safety. 

Why This Recall Guide Matters 

The updated GUI-0039 recall guidance reflects Health Canada’s ongoing commitment to consumer safety. It provides a comprehensive framework for recalling health products, including: 

• Prescription and over-the-counter drugs 
• Natural health products (vitamins, supplements, etc.) 
• Biocides (disinfectants, pest control agents, etc.) 

The guide is especially critical for manufacturers, distributors, and importers looking to maintain recall compliance. Health Canada expects regulated parties to have robust procedures in place for both voluntary recalls and mandated recalls, including timely reporting, thorough documentation, and effective communication strategies. The ability to voluntarily recall products when necessary is essential to protect public health and demonstrates a proactive approach to regulatory compliance.  

Key Responsibilities in the Canadian Health Product Recall Process 

Under the Canadian drug and NHP recall regulations, all parties involved in the distribution chain (each regulated party and collectively regulated parties, including manufacturers, importers, distributors, and other entities subject to regulatory oversight) must: 

• Clearly define and understand their roles as a regulated party 
• Notify consignees and Health Canada promptly 
• Remove or correct affected product lots
• Maintain quality agreements that assign clear recall duties
• Keep comprehensive documentation for traceability 

Participants include: 

• Manufacturer or importer (as the primary regulated party responsible for initiating recalls) 
• Manufacturer and importer (with specific regulatory obligations for recall reporting) 
• Distributors 
• Wholesalers 
• Retailers 

Regulated parties can have recall reporting obligations, including timely notification to Health Canada and submission of detailed information during both voluntary and ordered recalls. 

Maintaining accurate recall records is essential for demonstrating compliance and facilitating audits by health authorities. 

Why Recall Readiness Is Critical for Canadian Health Product Companies 

Non-compliance with drug, NHP, or biocide recall requirements in Canada can lead to enforcement actions, including public safety alerts, regulatory penalties, or licence suspensions. Health Canada uses various compliance and enforcement actions to ensure companies follow laws and maintain consumer safety. 

Having a tested, documented recall procedure is essential for: 

• Minimizing brand damage 
• Protecting consumer trust 
• Meeting Health Canada quality system requirements 
• Supporting recall readiness through adherence to good manufacturing practices (GMP)
• Ensuring the company demonstrates evidence of compliance during inspections or audits 

Need Help with Your QMS? 

Dell Tech’s regulatory and quality experts can help you: 

• Develop a Quality Management System (QMS) for drug, NHP, or biocide compliance 
• Audit your current recall procedures 
• Ensure full compliance with GUI-0039 recall guidance 

📞 Contact us today to ensure your recall systems are compliant and audit-ready. 

DELL TECH HAS PROVIDED PROFESSIONAL, CONFIDENTIAL CONSULTING SERVICES TO THE SPECIALTY CHEMICAL INDUSTRY IN CANADA, THE USA, EUROPE AND ASIA FOR THE LAST 40 YEARS.