Summary: Recall policy for health products


This policy outlines what is expected of those planning for, and conducting recalls of health products in Canada. These requirements are set out by:

  • the Food and Drugs Act (the Act)
  • Food and Drug Regulations (FDR)
  • Medical Devices Regulations (MDR)
  • Natural Health Products Regulations (NHPR)
  • Blood Regulations
  • Processing and Distribution of Semen for Assisted Conception Regulations
  • Safety of Human Cells, Tissues and Organs for Transplantation Regulations

Who this policy is for

This policy is for people who work with:

  • drugs as: sellers, distributors, manufacturers, importers, packagers, labelers and wholesalers
  • medical devices as: sellers, distributors, manufacturers and importers
  • natural health products as: product licence holders, manufacturers, importers, packagers, labellers and distributors
  • blood products including sellers
  • cells, tissues and organs for transplantation
  • semen for assisted conception, as: sellers, processors and distributors

In this policy

View complete policy
Download PDF (1.1 MB, 27 pages)

Details and history

Date issued: August 15, 2019

Date of implementation: August 15, 2019

For assistance

For general inquiries:

For drugs and natural health products by email:
For medical devices by email:
For blood, cells, tissues, organs and semen by email:

Page details

Date modified: