Microbial pathogens

Food recall guide for manufacturing and processing facilities

Even with the most stringent protocols and processes in place, food manufacturers still face the possibility of a food recall. But implementing the right controls and policies can help reduce the probability of having to take your product off the shelves.

Understanding food recalls

Incorrectly applied labels, accidentally added ingredients, and sensors that go out of calibration without warning. Food safety is at the top of any manufacturer’s agenda, and yet there are still so many things that can go wrong. Sometimes issues require manufacturers to remove defected or contaminated foods from sales and distribution—otherwise known as a recall.

In the United States, food recalls are handled by either the United States Department of Agriculture (USDA) which has a Food Safety Inspection Service (FSIS) enforcement arm or the Food and Drug Administration (FDA).

Under USDA FSIS: Meat, Egg product, poultry. Under FDA: Animal food, dairy products, all other foods and beverages. Under USDA FSIS: Meat, Egg product, poultry. Under FDA: Animal food, dairy products, all other foods and beverages.

The FDA organizes recall classification according to severity:

  • Class I: Products that could cause serious injury or death. For example, the presence of microorganisms such as Listeria or Salmonella.
  • Class II: Products that might cause serious injury or temporary illness. For example, food that contains yeast or mold contamination.
  • Class III: Products unlikely to cause injury or illness, but that violate regulations. For example, a mislabeled product, incorrect weight, or water added to meat.

The first major national food recall occurred in 1920, with an outbreak of botulism linked to improperly canned olives. At its peak in 2016, the total number of food recalls in the United States reached 905. Fast forward to 2019, and the food industry experienced 337 recalls—212 issued by the FDA and 125 issued by USDA FSIS.

1. Manufacturer saying their product hasn't been inspected. 2. Phone alert saying the FDA is calling for salad to be recalled. 3. Consumer calling to complain about allergens.

Food recalls happen. Here’s why.

Even food manufacturers with the most stringent protocols and processes can face a food recall. These can be initiated by the manufacturers themselves, regulatory agencies, or consumers.

Some products are more prone to food recalls than others. For example, fresh produce welcomes the opportunity for contamination in the water or during handling. Sometimes operators change over lines and SKUs before properly cleaning the machines. And sometimes foreign objects enter the packaging area without being detected on the line’s vision inspection equipment (if one even exists).

The four types of food contamination are microbial, allergenic, chemical and physical.



Microbial contaminants, like E. coli and Salmonella, are the most commonly discussed in the media because they are the most likely to cause widespread foodborne illness. There are countless opportunities for pathogens to be introduced along the food processing chain, and they can result in severe illness or death for consumers.



Food allergens result in about 30,000 emergency room visits every year. While preventing cross-contamination through clean work practices is the most obvious method to prevent a recall, it’s not the only thing manufacturers have to worry about. In fact, the leading cause of food recalls in the U.S. is undeclared allergens.

Another challenge with allergens is importing to and exporting from other countries. For example, regulatory agencies in Canada and in Europe consider celery and mustard allergens, but we don’t in the United States. In fact, there are 11 allergens listed for when exporting to Canada and 14 for Europe versus the eight allergens listed for the United States.



Chemicals must be properly segregated, or contaminants can enter food during warehousing, transportation, and storage. Unless you follow proper procedures, cross-contamination can occur with chemicals used in cleaning and disinfection during manufacturing. Chemical contamination is rare but can lead to illness or injury.



Foreign objects, like hair, insects, pieces of plastic, glass, or metal can contaminate food, pose a choking hazard, or cause injury. Foreign material contamination can come from many sources such as raw materials, packaging materials, or equipment—especially when employees don’t follow proper personal protection and hygiene procedures. Mechanical wear and tear can also be a major source of physical contamination.

Additionally, recalls can occur for reasons aside from contamination, such as mislabeling. While mislabeling doesn’t always pose a risk to public health, it is a common case for a food recall. Imagine the time and money wasted on having to re-label packaging, cans, containers, boxes, and pallets with a new label. Not to mention the labeling lawsuits that have arisen in recent years.

How to prepare for a food recall

Once a recall takes place, it becomes public record. And, thanks to a consumer base with access to social media, a recall—regardless of where it derives from—can be detrimental to even the most seasoned companies. Case in point: Food withdrawals, rejections and recalls cost the food industry $7 billion annually.

That’s why food and beverage manufacturers must institute a series of steps and protocols to avoid and minimize the effects of a recall.

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Spell out the recall procedures

Just like with any company process, mapping out the procedures is key to getting everyone within an organization on the same page.

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Develop a food safety plan

This food safety plan is a requirement of the Food Safety Modernization Act (FSMA). The food safety plan must include the manager of the plant and team members from different areas of the company who will provide viewpoints on safety. This team sets the example, enforcing procedures and ensuring the safety and security of products coming and going from the facility.

A recall plan is one requirement within the food safety plan. You must prepare a recall plan for each product family, spelling out the procedures and responsibilities in case of a recall. Documentation of each step is very important. The recall plan should also include sample letters that go to the affected parties, like consignees, authorities, and the public.

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Conduct mock recalls

The company-appointed task force must periodically test recall plans. Test runs provide a way to identify issues, verify that the plan works and understand the steps should a real recall take place.

Mock recalls involve the production facility, warehousing, transportation, consignees, and legal and PR departments. Write sample letters and announcements that detail the food’s risks.

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Maintain proper records

Food recall plans will only work if it’s easy to trace the products, ingredients, and production steps. This, of course, entails proper storage of records, including ingredient CoAs (certificates of analysis), process control points, and shipping details. Records can be handled with the right automated software solutions, which should also be prepared for recall procedures.

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Turn to technology

Whether it be databases, blockchain, automation or track-and-trace solutions, many of today’s emerging technologies help produce, transport and store product in a safe, efficient manner. New technologies provide information to each step of the production and distribution chain and allow the producer and distributor to react quickly and efficiently.

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Don’t cut corners

Recalls are serious. The life of your business (and consumers) depends on the proper handling of a recall. Outline expectations for each individual and involve top management in communication and handling. Don’t cut corners. Make every step/procedure count and eliminate any room for error.

How to avoid food recalls in the design phase

Even though food recalls happen, there are ways to design a plant or production line to minimize the possibility. You have much more control over the outcome of your products in the design phase as evidenced by the fact that decisions made during the design phase can account for up to 70% of the product’s costs, while decisions made during production only account for 20% of the product’s costs.

For starters, consider working with an experienced design and construction firm. The right firm will understand food safety and offer a design that avoids recalls.

If the facility needs an upgrade, the design and construction firm can re-evaluate the layout and processes and make recommendations for how to mitigate risks. If the facility is new or expanded, the firm can design for safety from the original concept by considering key elements of food safety.

The key elements of food safety

Allergen segregation

Allergens have become one of the main issues in food plants, but that wasn’t necessarily an issue 10-15 years ago. So, with legacy plants, implementing a plan for allergen segregation is key to mitigating food recalls.

Optimized workflows

Consider the human component—how employees work, function, and train alongside automated machines—early in the design phase. Study the non-value-added activities that could increase the opportunity for contamination and optimize for safety.


Install automated technology designed to correct mislabeled products, detect undeclared allergens, reinforce the labeling process, and ensure formulation/ingredient control. Also, implement barcode technology that scans product labels to ensure traceability, thus preventing product from even leaving a facility should it contain ingredients not included on the label. Other safeguards such as x-ray scanning, metal detection, and filtration/sieving processes help catch foreign objects, like metal, wood, plastic, and more.

Sanitation and clean-in-place (CIP) systems

CIP systems are a great way to cut down on manual labor while keeping bacteria out of processing equipment. Just make sure to evaluate the CIP system frequently to make sure it is right-sized for your needs.

Air handling

Air is everywhere. It goes into every product and is on every surface. Having proper airflow can help prevent airborne contamination. Design air pressurization, filtration, and flow to minimize the risks of cross-contamination from allergens, microorganisms, or foreign material.

Continuous training is crucial

Mistakes happen. Human error happens. Personnel can be the largest differentiator when it comes to safety and quality. Motivated and well-trained employees will help minimize human errors and may also help to optimize production and prevent recalls. Training should not be only part of the onboarding of personnel, it should be continuous and must reinforce the procedures that each individual should follow. Training also provides an opportunity for the management and safety teams to learn from the employees about the efficacy and applicability of the existing written procedures.

The food and beverage industry keeps moving, leaving little time for recalls. But food recalls inevitably happen. With the right strategies in place, an experienced partner at your side, and continuous training for employees, companies can minimize the possibility of dealing with food recalls. Let’s talk about how CRB can help you develop and implement your food recall plan.

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