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Why are recalls required?

Recalls are intended to safeguard public health by informing consumers (when necessary) of the presence on the market of a potentially dangerous cannabis product and facilitating the efficient and prompt identification and removal of unsafe items from the distribution chain, ensuring that potentially dangerous products are destroyed or declared safe.


According to the data obtained in the last three years, the cannabis industry is still dealing with compliance issues. Looking at recall data over the last three years, we can see that labelling and packaging issues have caused 73 percent of recalls since October 2018. Pathogens account for 18% of all cannabis product recalls, making them the second most common cause. Despite being the second most frequently mentioned class, pathogens account for the greatest number of infected units [1].


Canadian Cannabis Recalls – Total number of affected units and noted causes (Image Ref: recalls-lessons-learned-after-three-years-of-Canadian-legalization/)

Labelling and packaging issues account for 73.2% of cannabis recalls since legalization in Canada (Image Ref: feature_article/cannabis-recalls-lessons-learned-after-three-years-of-Canadian- legalization/)

Recalls can be costly and lead to a loss of customer trust, but they are frequently avoidable. The challenge now is to figure out how to avoid recalls altogether.


1. Stay Abreast of the Rules and Regulations

It is more important than ever in today’s business environment to stay up to date on the rules and regulations that apply to your industry. Failure to do so can result in costly penalties such as product recalls and licence revocation.

 Furthermore, staying up to date on the latest regulations can give you a competitive advantage over your competitors. It is critical to be up to date and informed about any changes in the regulations. Having up-to-date information on all regulatory changes will allow you to amend your documentation appropriately and in a timely manner, avoiding any potential recall. 

Furthermore, in some cases, it is necessary to be aware of all applicable legislation. The Food and Drug Act and the Pest Control Products Regulations are two examples.


2. Interpretation of Regulations–Carefully read and interpret the regulations accurately

One important skill that is critical for success in many professions is the ability to read and interpret regulations. This can be a challenge, as regulations are often lengthy and filled with technical jargon. However, it is essential to be able to understand what the regulations say, as they can have a major impact on how you do your job.

Additionally, it is important to be able to interpret the regulations accurately, as even a small mistake can lead to significant consequences. You may not be able to enforce the regulations properly if you do not comprehend them. 

Before drafting necessary documentation and executing the regulations, get the advice of an expert if you are having difficulty interpreting.


3. Food safety is critical– Be aware, understand and manage risks

The first step in prevention is always to understand what you are attempting to prevent. For edibles and extracts, Health Canada requires the development of a preventative control plan (PCP). Identifying and mitigating all potential dangers, such as physical, biological, and chemical risks, is critical to the successful implementation of an effective PCP. 

It is also critical that all batch documents are produced in such a way that all recognized hazards in the process are avoided throughout processing and that there is a verification step. This will undoubtedly reduce the number of pathogen-related recalls in edibles and extracts. Good Production Practices (GPP) and Good Agricultural Practices (GAP) can be implemented to avoid pathogen-related recalls in cannabis flowers and pre-rolls.

4. Formulate Correctly – make sure your formulation is not prone to pathogen growth

Cannabis GPP is a good practice guide that details how to appropriately cultivate, harvest, dry, and cure cannabis. Cannabis GPP also outlines how to store cannabis safely. One aspect of Cannabis GPP that is essential to preventing pathogen growth is ensuring that your formulation of cannabis products is not prone to pathogen growth.

Cannabis products can be either solid or liquid, and each type has different risks for pathogen contamination. For example, water can easily become contaminated with pathogens, so any wet cannabis products (such as oils) must be very carefully formulated to prevent the growth of pathogens. Similarly, dry cannabis products (such as flower) must also be formulated to prevent pathogen growth. Dry cannabis is less susceptible to contamination because it does not have the moisture that pathogens need to grow. As a result, it is essential to ensure that your formulation of cannabis products is not prone to pathogen growth in order to prevent the growth of pathogens. Shelf-life and/or stability studies are strongly suggested as part of product approval.

5. Perform Random testing –Do not rely on COAs /COC from the suppliers only

Any company that relies on raw materials or finished goods from suppliers needs to have a robust system in place for testing those products. While a Certificate of Analysis or Certificate of Conformance from a supplier can provide some assurance of quality, it’s always best to perform your own tests as well. That way, you can be sure that the product meets your specific requirements and that it’s safe for use. 

There are many different ways to test products, but random testing is generally the most effective. You can ensure that the entire batch meets your standards by testing a small sample of products from each batch. The cost of testing is relatively low compared to the potential cost of using substandard materials, so it’s always worth the investment.

 Furthermore, suppliers frequently employ a certificate of conformity (COC), which is just an administrative declaration that the product, according to the provider, meets the standard specification. Random testing of raw materials in-house can improve product quality and avert recalls.

6. Finished Product Testing – Have a good sampling plan

Any good finished product testing plan should always include a sampling plan. This is because a sampling plan helps to ensure that you are testing a representative sample of the finished product and not just a small portion of it. Without a sampling plan, you may end up with results that are not representative of the finished product as a whole.
For example, if you only test a small portion of the finished product, you may miss out on potential problems that only occur in larger batches. Conversely, if you test too much of the finished product, you may end up wasting time and resources on testing that is not necessary. The key is to find the right balance, and a good sampling plan can help you do just that.

 It is critical to develop an SOP with a sampling plan that truly depicts the Batch. Furthermore, the execution of the written plan is critical. There is a risk if a plan is properly drafted but not executed.

7. Batch documents and Checklists

When it comes to quality control in the Cannabis industry, batch records are essential. A batch record is a historical record of all activities associated with the manufacture of a specific batch of products. In order to ensure compliance with Good Production Practices (GPPs), it is important to have accurate and up-to-date batch records.
There are a few key things to keep in mind when creating batch records:
  • Include all relevant information: When creating a batch record, be sure to include all relevant information, such as the name and quantity of each raw material used, the lot numbers of all components, details of the manufacturing process, and the date and time that each step was completed.
  • Make sure the record is legible: Batch records must be legible and easy to understand. Be sure to use clear and concise language, and avoid abbreviations where possible.
  • Use a standardized format: It is important to use a standardized format for batch records to ensure consistency and ease of understanding. Many companies have their own internal formats for batch records, so be sure to follow any specific guidelines that your company may have.
  • Keep records up to date: Batch records should be regularly updated throughout the manufacturing process. Be sure to revise the record if any changes are made to the process or product formulation.
  • Store records properly: Batch records must be stored in a secure location where they will not be damaged or lost. They should also be accessible to authorized personnel only.

By following these tips, you can help ensure that your batch records are accurate and compliant with GPPs.

It is also a good practice to create checklists for your batch documents to ensure compliance with all regulations. For example, to reduce the possibility of mislabeling, missing labelling information, and other issues, you can include several steps of label review and verification in your batch document.

8. Internal Audits or Self Inspection

A product recall is every manufacturer’s nightmare. Not only does it damage the reputation of the company, but it can also lead to legal problems and financial losses. One way to help avoid a product recall is to conduct regular internal audits or self-inspections.
By identifying potential problems early on, companies can take steps to fix them before they lead to a recall. Additionally, regular audits can help companies keep track of their manufacturing process and meet all safety and quality standards. In short, internal audits or self-inspections are an essential part of running a safe and successful business.

GMP regulations mandate internal audits or self-inspections. On the other hand, the Canadian cannabis industry abides by GPP in compliance with the Cannabis Act and regulations, which do not need this. This can be incorporated into the quality system of authorized producers to reduce the likelihood of recalls. To avoid bias, hire a third-party expert to conduct self-inspections.


9. Learn from others

No one wants to experience a recall, but unfortunately, they happen. The best way to prevent them is to learn from the mistakes of others. By visiting the Health Canada recall page, you can see what types of recalls have occurred in the past and take steps to avoid them in the future.
For example, if you see that several recalls have been caused by a certain type of food packaging, you can switch to a different brand that uses a different packaging material. Or, if you see that several recalls have been caused by a certain type of ingredient, you can look for products that don’t contain that ingredient.
By paying attention to the recalls that have happened in the past, you can help prevent them from happening to you in the future. Preventing recalls in this manner will benefit you in the long term.


Working diligently and investing a few extra dollars to get expert advice can save thousands of dollars in recall costs and increase customer trust in your product.

How We Can Help:

MFLRC is a one-stop shop for all of your quality assurance and compliance needs. Our team has years of experience in the cannabis industry and are expert in all facets. We offer a variety of services that will save you time and money. Let us take the burden off your shoulders so you can focus on what’s important – growing your business.

Some of our services include:

  • Perform an internal audit.
  • Prepare all the necessary documents and communicate with Health Canada in case of a recall.
  • Do a comprehensive investigation and determine the root cause of the recall. Take corrective and preventive actions.
  • Work with the licenced producer to implement all CAPAs

Contact us Now!





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Mussarat Fatima, President, and owner of MF Cannabis License and Regulatory Consultants has more than twenty years of experience in Quality Assurance, Quality Control, and Regulatory Affairs within the pharmaceutical, Food and Cannabis industries. She has a Master’s Degree in Food Sciences and Biochemistry; in addition to this, she also has a diploma in pharmaceutical Quality Assurance, Regulatory Affairs, and Quality Control. Also, she has completed several certifications specifically in Cannabis Quality Assurance, Regulatory Affairs, and Facility management from recognized institutes in Canada.

mflrc Mussarat Fatima

Written By: Mussarat Fatima
President at MF License & Regulatory Consultants

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