Tag Archives: Listeria monocytogenes

Listeria
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How to Get Rid of Listeria in your Food Facility

By Bob Lijana
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Listeria

Keeping the pathogen out of the plant is essentially what sanitarians preach. Sanitarians focus on minimizing the use of sanitizing chemicals. This strategy reduces costs and exposure to toxic chemicals, and by definition focuses attention on control strategies. These include identifying and studying hygienic zones, personnel hygiene, traffic patterns in the plant, and the array of sanitation steps taken over all shifts. An article by Dr. Bob Powitz describes this approach.

Eradicating Listeria when it is found is usually the result of a find it and kill it approach–often called “seek out and destroy”, an aphorism coined over a decade ago by  Dr. John Butts. The principles and techniques outlined in these mini-articles are very much aligned with this kind of approach. They are also the ones employed by most food companies in their management of Listeria risk. And that is mainly because Listeria can still find a way into a plant, in spite of best efforts to the contrary.

It is beyond the scope of this mini-article to go into all of the different chemicals that can be used to attack Listeria. Common chemicals include peroxyacetic acid, often used in plants for which an organic sanitizer must be used. Chlorine dioxide gas is used when companies want to introduce a sanitizing chemical across the entire plant, essentially as a “fumigation” technique. This can be useful since the gas can reach areas in which liquid sanitization techniques are ineffective.

The most common chemicals used against Listeria are the “quats”, mixtures of quaternary ammonium compounds. Not only are these compounds effective sanitizers, but it is generally believed that quats have a substantive property which allows them to remain on surfaces for a time. Thus they can have an ongoing effect against Listeria.

Highly experienced food plant chemical companies are well versed in sanitation chemicals and procedures. They are the best source for determining which chemicals are the most effective for your situation, at what concentrations (e.g., to achieve a no-rinse level on equipment), and with best-practice standard sanitation procedures. Highly reputable chemical companies understand sanitation, sanitization, and disinfection–and they can teach these concepts, and solve contamination issues.

FDA (“draft guidance for industry”) and USDA (“compliance guideline”) provide guidance on what corrective actions (e.g., sanitization) are required when Listeria is found. Regardless of which actions are decided upon, their effectiveness must be verified and validated. This requires well thought out statistical sampling and risk assessment, and continued testing.

Constant vigilance is very important. Use checklists that are centered on GMPs (Good Manufacturing Practices) as a start, using these to ensure that areas are sampled appropriately. But make sure that you are not solely relying on checklists (see this article on checklists that can be traps). Too often, companies find Listeria, throw some sanitizer on the area in question, sample, get a negative (the pathogen is no longer found in that location)–and then move on, convinced that they have solved the problem.

This is rarely the real outcome unless you have determined definitively that the root source has been eliminated. In addition, you have to be convinced that the transfer points around the root source are no longer in play. They have to be eliminated or highly controlled.

Said another way, you are rarely done. As frustrating as this might seem, constant microbiological vigilance is what keeps your products safe. Not doing so can end up being very costly to the company in insurance costs, recall costs, and legal costs, and in brand image to customers and consumers. All are avoidable.

It is much better to maintain and improve your environmental monitoring programs to constantly protect public health. So keep sampling and testing!

This is the 5th in a series of 6 Listeria in Food Plants articles. See the Related Articles below to read the series.

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Listeria
Ask The Expert

How to Find Listeria in a Food Facility

By Bob Lijana
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Listeria

Before you go looking for Listeria, you need to make sure that senior management across all functions is supportive of this task–especially when Listeria is found. Will someone (or some function such as QA) get blamed? Will enough resources be given? Will outward communications (e.g., to customers or FDA) be actively managed?

Or is the collective opinion “we do not need to know, because Listeria is surely not here”?

Most food companies make the correct strategic and ethical decision to test for Listeria. To that end, they typically test for the genus of Listeria species (L. spp.), and not specifically for Listeria monocytogenes (Lm). Thus, they do not end up with confirmation that Lm is present and therefore do not butt up against a regulatory zero-tolerance policy. But they get a strong indication that conditions are favorable to Listeria growth, so they can choose to assume that Lm is present and act accordingly. If corrective actions are taken to eliminate all Listeria, then one can justify that if Lm were present, it would be eradicated by these corrective actions.

Some companies test for a “marker organism” such as Listeria innocua. The thinking is the same as that above. This includes making the assumption that if Listeria innocua is found, then Lm may indeed also be present.

If your company has decided to look for Listeria, how do you go about doing so? The overall objective is to establish, validate, and execute an “environmental monitoring program” (EMP). Good starting points are the “Environmental Monitoring Handbook” published by 3M and Cornell University and a publication by the Institute of Food Technologists, “Design Elements of Listeria Environmental Monitoring Programs in Food Processing Facilities.” For seafood, the National Fisheries Institute has a publication on ready to eat seafood pathogen control.

Key to an effective EMP is sampling. Sampling is complicated to plan since the choices affect time and money. How many samples, where, and what are you sampling for (e.g., Lm, Listeria innocua, or L. spp.) ? These choices affect costs and how soon, or not, microbiological results are received. Random sampling never carries the day. Rather, sampling needs to be strategic—based on sound statistical principles, science, and  your own assessment of what might really be going on.

Building a useful EMP is hard work, and requires a lot of patience and a lot of data. Listeria does not sit still–plant conditions change all the time. Hence, a positive sample today does not guarantee that there will be a positive sample tomorrow (especially when microbiology results take days to obtain). A good EMP finds growth niches and transfer points, and helps determine the overall risk for nearby food becoming contaminated.

In addition, actual as-made equipment design is incredibly important. Equipment not made hygienically, or that has been changed over time (“to make it work better”), may end up being a root-source of Lm. A good review of proper hygienic design can be found in “Food Safety Equipment Design Principles” by the Foundation for Meat & Poultry Research & Education.

Here are some effective approaches used in the food industry:

  1. Bring in an expert third-party consultant or company to do the work for you.
  2. Utilize the services of a certified and vetted microbiology lab, and partner with them.
  3. Purchase best-practice software which models an EMP, and directs sampling for you.
  4. Review the FDA and USDA guidance documents for direction–and then speak with your local regulators. (Yes, this is not without some risk.)
  5. Conduct multiple “swab-a-thons” in your plant, sampling anywhere and everywhere to gather microbiological data. As mentioned above, it can be notoriously difficult to establish patterns of harborage and movement–but having hundreds of data points can at least give you a snapshot for the microbiological cleanliness of the plant. Note that this is time-consuming and costly, but could pay dividends if this is one of your only options.
  6. Study, study, study. Map and analyze traffic patterns in the plant, evaluate water use and water flows (e.g., to and from drains), sample equipment around product zones, look at data from pre-operational activities, look at past microbiological sampling data, and talk with the sanitation team about what they see.

Note that it is generally not recommended to sample actual product given the regulatory consequences if Lm is found!

Regardless of the tactics chosen, Lm is typically hard to find in a “clean” plant. And determining where it comes from (i.e., the root source) is even harder. Microbial testing is still the best way to do this. Techniques such as ATP testing, total plate count or Enterobacter testing, and PCR-assay Listeria test kits can help guide you. But those results are only as good as the level of technical thinking that is brought to the them. One must truly evaluate where Listeria growth niches might be, regardless of how easy or hard it is to access those locations.

See the Related Articles below to read the series.

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Listeria
Ask The Expert

Listeria 101, the first article in a series on Listeria in Food Plants

By Bob Lijana
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Listeria

Listeria” is a family of bacteria. Almost all of the family members get along well with each other and with humans–so much so that people often do not even know the names of these “friendly” bacteria. But one member of the family, Listeria monocytogenes, is a bad actor, a pathogen. If a susceptible person (e.g., immunocompromised) gets infected with Listeria monocytogenes, they could easily get listeriosis. Consequences of this infection include sepsis, meningitis, encephalitis, and death.

Listeria was named in honor of a famous British surgeon, Sir Joseph Lister (from whom the trade name Listerine also comes from), who advocated for the use of antiseptics during surgery. Microbiologically speaking, Listeria species (i.e., “Listeria spp.”) are Gram-positive, facultative anaerobes, which means that they can grow in environments which do not have much oxygen.

Listeria monocytogenes (Lm) is one of the most virulent food-borne pathogens. It can be found in dirt, sewage, rivers and streams, rotting vegetation, and animal feces. Hence, it can easily find its way into a food facility through someone’s shoes, or equipment, or ingredients brought into the plant.

Lm is an extremely strong organism, able to survive pH ranges of 4 to 9, and temperatures from 32F to 113F. It can survive freezing conditions, very dry surroundings, and salty environments. The organism will not necessarily grow under those conditions, but once those conditions revert to more favorable ones, it can begin to grow again. Lm often forms “biofilms” (protective matrices) that protect the organism from being found and make it that much harder to eradicate.

All of these characteristics make Listeria an insidious pathogen.

FDA has published a summary of Lm in “Get the Facts About Listeria.” This summary includes statistics, background, and references. FDA also has a well-vetted set of microbiological procedures to identify Lm in its Bacteriological Analytical Manual.

A thorough microbiology reference book is “Modern Food Microbiology”. Chapter 3 discusses the characteristics of foods which affect pathogen growth, and Chapter 25 covers listeriosis.

Other Listeria species, such as Listeria innocua and Listeria welshimeri, are not pathogenic, and actually compete with Lm. So a microbiological sample taken which is positive for L. innocua might lead one to conclude that Lm is not present when it really is.

Food manufacturers and regulators often judge cooked foods as less risky than ready-to-eat (RTE) foods because cooking kills bacteria. Foods with low pH, preservatives, and/or low water activity (these are sometimes referred to as formulation hurdles) may also be judged as lower risk. However, don’t assume cooked or preserved foods are free of Listeria monocytogenes, as it’s a tough organism. Do your testing and validation work to confirm that Lm is under control.

Editors Note:  This article is the first in a series of six brief articles on Listeria. They are intended for food science professionals, especially food safety and quality assurance people. The information presented in these mini-articles will also be of interest to people in all functions.

See the Related Articles below to read the series.

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Beltway Beat

Maryland District Court Enters Consent Decree of Permanent Injunction against Totally Cool and CEO

By Food Safety Tech Staff
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The FDA announced that on Tuesday, March 18, the United States District Court for the District of Maryland entered a consent decree of permanent injunction against Totally Cool, Inc., a Maryland-based manufacturer of ice cream and frozen desserts, and its CEO and owner, Michael J. Uhlfelder. On July 8, 2024, the FDA suspended Totally Cool’s food facility registration after an inspection of the firm revealed Listeria monocytogenes in the facility, as well as numerous failures of the firm to adhere to current good manufacturing practice for food safety, including sanitation requirements for employees and equipment. The consent decree prohibits Totally Cool and Mr. Uhlfelder from directly or indirectly receiving, preparing, processing, packing, holding, and/or distributing any article of food unless and until they meet certain requirements.

In 2024, Totally Cool recalled over 65 ice cream products due to listeria contamination.  The brands involved were Abilyn’s Frozen Bakery, Amafruits, Chipwich, Cumberland Farms, Dolcezza Gelato, Friendly’s, Hershey’s Ice Cream, Jeni’s, LaSalle, Marco, Taharka Brothers, the Frozen Farmer and Yelloh. More than 65 products were recalled, including ice cream cakes and sandwiches, as well as sorbets.

Lyons Magnus Recalls Lyons ReadyCare and Sysco Imperial Frozen Supplemental Shakes Manufactured by Third Party Because of Listeria Contamination

By Food Safety Tech Staff
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Lyons Magnus LLC announced in a press release on February 22, that it is voluntarily recalling 4 oz. Lyons ReadyCare and Sysco Imperial Frozen Supplemental Shakes due to the potential for the products to be contaminated with Listeria monocytogenes. Lyons Magnus is taking this action in response to a recall of the products by their manufacturer, Prairie Farms Dairy, Inc. (“Prairie Farms”) from the Prairie Farms facility in Fort Wayne, Indiana.

According the the press release, Lyons Magnus handled distribution of the recalled products, which were manufactured and supplied to Lyons Magnus by Prairie Farms. The recalled products were distributed primarily to long-term care facilities and were not available for retail sale. The recall is being conducted in cooperation with Prairie Farms, Sysco, and the U.S. Food and Drug Administration.

On November 25, 2024, FDA reported it was was notified about an outbreak of Listeria monocytogenes in the United States, with many ill people residing in long-term care facilities (LTCF) prior to illness onset. FDA’s traceback investigation identified that each of the LTCF who supplied invoice information for review from 2024 to present received a frozen supplemental shake of either Lyons ReadyCare or Sysco Imperial brand. As part of this investigation, FDA collected environmental samples and found the outbreak strain of Listeria.

According to CDC, this outbreak includes cases dating back to 2018, with 20 cases across 2024 and 2025, and is currently ongoing. Epidemiologic evidence in previous investigations were unable to identify a source of the outbreak. As of February 21, 2025, a total of 38 people infected with the outbreak strain of Listeria monocytogenes have been reported from 21 states. Of the 38 people for whom information is available, 37 people have been hospitalized. Eleven deaths have been reported. Of the 38 people for whom information is available, 34 (89%) reported living in long term care facilities or were hospitalized prior to becoming sick. Records reviewed from facilities indicated nutritional shakes were available to residents.

Lyons Magnus claims, as soon as it learned of the issue, it took immediate action to halt the purchase of all products from the affected Prairie Farms facility, notify customers, and ensure that impacted products were removed from distribution nationally.

 

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Beltway Beat

FSIS Announces Stronger Measures to Protect the Public from Listeria monocytogenes

By Food Safety Tech Staff
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The changes FSIS is announcing fall into three categories: enhancing its science-based approach to mitigate foodborne pathogens, with a key focus on Listeria monocytogenes; improving training and tools for its inspection workforce; and evolving its oversight of regulated facilities, with an emphasis on data review and state inspection agreements. FSIS will initiate the following changes in the next 30 days:

Enhancing FSIS’ Regulatory and Sampling Approach to Listeria 

  • Effective January 2025, FSIS will add broader Listeria species testing to all samples of ready-to-eat product, environmental and food contact surfaces. FSIS laboratories currently test these samples for Listeria monocytogenes, which is the specific type of Listeria species that causes illness. However, adding additional species testing to the agency’s regulatory framework will help provide more information about the effectiveness of a facility’s sanitation program and can signal to FSIS if follow up is needed (for example, a Food Safety Assessment, intensified sampling, or enforcement actions).
  • FSIS will leverage the expertise of its National Advisory Committee on Microbiological Criteria for Foods (NACMCF). NACMCF is a federal advisory committee that provides scientific advice and recommendations to USDA and other government agencies on microbiological and public health issues. In December, FSIS will begin recruitment for new committee members, who will be given the specific charge of reviewing the agency’s regulatory approach to Listeria monocytogenes. Expertise in Listeria will be sought for membership. The committee’s input will be used to guide more long-term policy changes.

Equipping FSIS Inspectors with Updated Training and Tools to Recognize and Respond to Systemic Food Safety Issues

  • FSIS will update its instructions and training for food safety inspectors to better equip the workforce to recognize and highlight systemic problems in a standardized way. Agency inspectors will receive updated instructions and training, and FSIS field supervisors will routinely review these instructions with inspectors to ensure full understanding and appropriate application. Inspectors will also receive supplemental Listeria monocytogenes control training designed to help strengthen inspectors’ understanding of the regulatory requirements in FSIS’ Listeria Rule and how to verify establishments have designed and implemented food safety systems that comply with those requirements.
  • FSIS will conduct Food Safety Assessments (in-depth food safety reviews) at ready-to-eat meat and poultry facilities. In FY 2025, FSIS is prioritizing completion of Food Safety Assessments at ready-to-eat meat and poultry facilities that rely exclusively on sanitation measures to control for Listeria. These reviews will provide information about the plants individually and collectively and could inform future policy or process changes to target this microorganism.
  • FSIS field supervisors will conduct in-person, follow-up visits when systemic issues are identified during a Food Safety Assessment. Follow-up visits by FSIS field supervisors will bolster oversight from more senior inspection staff to ensure a facility fully addresses issues identified during a Food Safety Assessment and could inform enforcement action by FSIS. Field supervisors will work with inspectors to ensure the facility stays in compliance.

Tightening Oversight of Regulated Establishments, Including Those Under State Inspection Models

  • FSIS inspectors will verify specific Listeria monocytogenes-related risk factors at ready-to-eat facilities weekly. These risk factors include changes in physical plant modifications, such as new construction; indicators of sanitation problems, such as condensation, roof leaks, damaged equipment, or cracked floors; and Listeria species or Listeria monocytogenes positive test results from company testing. FSIS district offices, agency field supervisors and inspectors will review, analyze and consider the weekly data from each facility to determine if there are systemic issues that warrant further action, such as a Food Safety Assessment, intensified sampling, or enforcement steps.
  • FSIS will clarify state and Federal requirements for consistent oversight of Talmadge-Aiken (TA) programs through updated cooperative agreements and instructions. Through updated cooperative agreements with each participating state, FSIS will set specific requirements, including clear expectations for oversight, enforcing federal food safety laws, comprehensive federal training for TA inspectors, and enhanced regular coordination with FSIS. FSIS will also designate field and headquarters positions assigned to TA oversight; will clarify training requirements and criteria to start, maintain and terminate state inspection coverage of an establishment.
  • FSIS will revise establishment-review alert triggers. One significant criterion used to guide a district office’s decision to conduct a Public Health Risk Evaluation (PHRE), which typically precedes a Food Safety Assessment, is a monthly list of facilities with higher rates of noncompliance related to public health that is generated using an algorithm. Using additional data from the new weekly verification of Listeria monocytogenes-related risk factors, FSIS intends to update its algorithm and triggers to better identify high-risk facilities.

According to a USDA press release, these actions are intended to strengthen FSIS’ inspection and oversight by enhancing its ability to proactively identify and respond to the types of systemic problems that could lead to outbreaks. Listeria monocytogenes is a pathogen of particular concern because it can be especially harmful to people with compromised immune systems, like the elderly and pregnant women, and it can contaminate foods that are not cooked before consumption.

FSIS is continuing to identify other steps that would improve control of Listeria monocytogenes, dependent on funding availability. As requested in the FY 2025 President’s Budget, additional resources are necessary for the agency to continue to meet its mission to keep meat, poultry, and egg products safe and wholesome.

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Retail Food Safety Forum

Totally Cool, Inc., Recalls All Ice Cream Products Because of Possible Lm Contamination

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According the the FDA’s website, Totally Cool, Inc. of Owings Mills, Maryland is recalling multiple brands of ice cream products, because they have the potential to be contaminated with Listeria monocytogenes. Products were distributed nationwide, and available in retail locations and direct delivery. No illnesses have been reported to date.

The brands involved were Abilyn’s Frozen Bakery, Amafruits, Chipwich, Cumberland Farms, Dolcezza Gelato, Friendly’s, Hershey’s Ice Cream, Jeni’s, LaSalle, Marco, Taharka Brothers, the Frozen Farmer and Yelloh. More than 65 products were recalled, including ice cream cakes and sandwiches, as well as sorbets, according to a list published by the FDA that includes expiration dates.

Totally Cool, Inc. has ceased the production and distribution of the affected products due to FDA sampling which discovered the presence of Listeria monocytogenes. The company continues its investigation and is taking preventive actions. No other products produced by Totally Cool, Inc. are impacted by this recall.

 

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FDA Releases 2022 Annual Report on Investigations of Foodborne Outbreaks

By Food Safety Tech Staff
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On January 8, the FDA Coordinated Outbreak Response & Evaluation (CORE) Network released its first annual report summarizing the investigations of foodborne outbreaks and adverse events in FDA-regulated human foods for the 2022 calendar year.

In 2022, CORE evaluated 65 incidents, responded to 28 and issued advisories for 11. These numbers show a slight increase from 2021 when 59 incidents were evaluated with 19 responses and 10 advisories. The investigations in 2022 included E. coli, Cronobacter, hepatitis A virus, Listeria monocytogenes, and Salmonella which were linked to a variety of products, including produce, dairy and fish.

CORE investigations also resulted in numerous public health actions, including recalls, public health advisories, Warning Letters, FDA prevention strategies, a country-wide Import Alert and a Consent Decree. Outbreak advisories were issued for:

  • E. coli O157:H7 linked to packaged salads
  • Cronobacter linked to infant formula
  • Salmonella Senftenberg linked to peanut butter
  • Hepatitis A Virus linked to strawberries
  • Unknown contaminant linked to French Lentil and Leek Crumbles
  • Listeria monocytogenes linked to ice cream
  • Listeria monocytogenes linked to Brie and Camembert soft cheese products
  • E. coli O121 linked to frozen falafel
  • Salmonella Litchfield linked to seafood
  • Listeria monocytogenes linked to enoki mushrooms
  • Salmonella Typhimurium linked to sprouts

The 2022 annual report highlights noteworthy outbreaks from 2022, including Listeria monocytogenes linked to enoki mushrooms, Salmonella linked to cantaloupe and Salmonella linked to peanut butter.

Read the full report here.

 

Recall

Multi-State Listeria Outbreak Linked to Peaches, Plums and Nectarines

By Food Safety Tech Staff
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Recall

The FDA has identified peaches, plums and nectarines as the likely source of a multistate outbreak of Listeria monocytogenes, leading to a voluntary recall by HMC Farms.

The FDA and CDC, in collaboration with state and local partners, have been investigating the outbreak as new matching cases have been identified over the past several years. To date, there have been 11 reported illnesses, 10 hospitalizations and one death associated with the outbreak, spanning seven states (CA, CO, FL, IL, KS, MI, OH). Samples from sick people were collected from August 22, 2018, to August 16, 2023. According to a case-case analysis conducted by CDC, people in this outbreak were 18 times more likely to eat peaches, plums, or nectarines. This suggests that peaches, plums, and nectarines, are a likely source of this outbreak.  On October 23, 2023, FDA collected samples of 2lb bagged peaches at The HMC Group Cold Storage in Kingsburg, California, and on November 7, 2023, the samples were reported positive and a match to the outbreak strain by Whole Genome Sequencing.

In response to this investigation, HMC Farms has voluntarily recalled peaches, plums, and nectarines sold in retail stores from May 1, 2022, through November 15, 2022, and from May 1, 2023, through November 15, 2023. The recalled fruit was sold at retail stores as individual pieces of fruit bearing PLU stickers or in consumer packaging; however, the recalled fruit is no longer available for sale and any previously purchased fruit should be past shelf life. The recalled products may still be in consumer’s freezers; the FDA is directing anyone who previously purchased the recalled fresh peaches, plums and nectarines and then froze them, to throw them away.

 

Brie Cheese

FDA Links Listeria monocytogenes Outbreak to Old Europe Cheese Brie and Camembert Soft Cheese Products

By Food Safety Tech Staff
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Brie Cheese

A multistate outbreak of Listeria monocytogenes infections has been linked to Brie and Camembert soft cheese products manufactured by Old Europe Cheese, Inc. of Benton Harbor, Michigan. The products are sold at various retailers under multiple labels and brands. Six cases of illness have been reported in patients in California, Georgia, Massachusetts, Michigan, New Jersey and Texas.

The FDA reports that epidemiologic information provided by CDC found that, of the five patients with information available, four reported eating Brie or Camembert cheese prior to their illnesses. An FDA inspection of the Old Europe Cheese, Inc. facility in Michigan, performed with assistance from the Michigan Department of Agriculture and Rural Development, showed the presence of Listeria monocytogenes. Whole Genome Sequencing (WGS) analysis determined that the Listeria strain found in the facility matches the Listeria strain causing illness in this outbreak.

The company has voluntarily recalled multiple brands of its Brie and Camembert cheeses produced at the facility in response to the investigation findings. The firm has also halted production and distribution of its Brie and Camembert products from the Michigan facility and is working with FDA on corrective actions.

Consumers, restaurants and retailers should not eat, sell or serve recalled products and should throw them away; this includes Best By Dates ranging from September 28, 2022 to December 14, 2022—all flavors and quantities. A full list of recalled products and stores that potentially sold these products is available on the firm’s recall.