E. coli O157:H7 and Contaminated Darwin’s Natural Pet Products

This story by Bill Marler first appeared on the Marler Blog and is reposted here with the author’s permission.

On August 19, 2024, four-year-old Noah Ruiz experienced onset of diarrhea. A stool specimen collected at St. George Regional Medical Center on 8/22/2024 was PCR positive for E. coli O157:H7. The Utah Department of Health (UDH) State Public Health Laboratory (SPHL) isolated E. coli O157:H7 in Noah’s specimen (Accession Number 2017861). UDH SPHL conducted whole genome sequencing (WGS) on Noah’s isolate. Results were assigned identification numbers PNUSAE198092/SAMN43527540 and Allele code EC1.1-1.1.259.1566. Noah developed Hemolytic Uremic Syndrome and spent a month at Intermountain Health Primary Children’s Hospital.

Public health investigators interviewed Noah’s parents about potential exposures to E. coli O157:H7. Noah’s food history was unremarkable. He did not consume ground beef, leafy greens, sprouts, or fresh herbs. Investigators noted that Noah did have close contact with his dog who was fed Darwin’s Raw Pet Food. The dog, who exclusively consumed Darwin’s pet food, began vomiting one day before Noah became ill. The dog’s symptoms resolved without veterinary care. Noah’s parents reported that Noah had direct contact with the dog but had no known direct contact with the dog food.

Raw pet food, like other uncooked animal products, is not subjected to a validated kill step to eliminate pathogenic microorganisms prior to distribution. As a result, it may harbor dangerous pathogens such as Salmonella, Listeria monocytogenes, and pathogenic Escherichia coli. These organisms can persist in raw meat and contaminate surfaces, feeding utensils, and the surrounding environment during routine handling and feeding.

Pets that consume contaminated raw food can become infected and may shed pathogens in their saliva and feces, even if they appear clinically healthy. This creates multiple avenues for transmission within the household. Children are particularly at risk because they frequently engage in close contact with pets, including touching, petting, and exposure to contaminated surfaces. Transmission can occur through direct contact with the animal, contact with contaminated household environments, or improper handling of the raw product itself.

Vulnerable populations—including young children, the elderly, pregnant women, and immunocompromised individuals—face an elevated risk of severe illness when exposed to pathogenic E. coli and other foodborne pathogens. Infections may result in serious complications, including hemolytic uremic syndrome (HUS), a potentially life-threatening condition. Given these risks, the handling and use of raw pet food products presents a foreseeable and preventable public health hazard, particularly in households with high-risk individuals.

In May 2025, Noah’s parents provided unopened frozen packages of Darwin’s pet food for testing to IEH Laboratories & Consulting Group, a private laboratory accredited by the FDA Laboratory Accreditation for Analyses of Foods (LAAF) program. IEH Laboratories isolated E. coli O157:H7 in a sample of Darwin’s Beef Dog Food (Lot 10662). In addition, one sample of Darwin’s Chicken Dog Food tested positive for Salmonella Infantis (Lot 10683), and one sample of Darwin’s Duck Dog Food (Lot 10638) tested positive for Salmonella Hadar. IEH Laboratories & Consulting Group conducted WGS on an E. coli O157:H7 isolate obtained in a sample of Darwin’s Natural Pet Product Biologics Beef Recipe for Dogs. WGS results were assigned CFSAN142494 and posted on the National Center for Biotechnology Information. The E. coli O157:H7 isolated in the dog food was a genetic match to the E. coli O157:H7 isolated in Noah Ruiz.

On July 7, 2025, Noah’s father, Fred Ruiz, was interviewed by FDA Investigator, Antonetta M. Colacchio. Fred summarized in a sworn statement dated July 8, 2025, that the family dog, Rodeo, had been fed Darwin’s Natural Pet Products for ten years. He provided Investigator Colacchio with Darwin’s Natural Pet Products order confirmations dated June 14, 2024, and August 9, 2024. He described how the product was delivered frozen to his home and immediately placed in the freezer. Freezer space was dedicated to just holding the frozen pet food. A package of frozen dog food was placed in a dedicated open plastic container and set to thaw in their refrigerator. Rodeo was fed in the laundry room. Immediately after feeding, the food bowl was rinsed and placed in the dishwasher to sanitize. Fred said that his children, Noah and Roman, were aware and taught not to touch or handle any of the raw pet food. They were not allowed to help feed Rodeo. Rodeo did not eat any other food or treats. Fred also stated that Noah and Roman would cuddle and play with Rodeo all the time and that Rodeo would occasionally lick his sons’ faces when they interacted.

On July 29, 2025, the FDA issued an advisory cautioning pet owners that they should not feed certain lots of Darwin’s Natural Pet Products Pet Food due to contamination with E. coli O157:H7 and Salmonella. FDA recommended that Arrow Reliance Inc., the maker of Darwin’s Natural Pet Food Products, recall the product lots that tested positive for foodborne pathogens. At the time the advisory was issued, the firm had not recalled the affected products. The advisory noted that the products, which were manufactured in May or June 2024, were sold frozen, had no expiration date on the label, and could still be in consumers’ freezers. The FDA advised consumers to check their freezers for the affected lots of Darwin’s Natural Pet Products prior to feeding their pets.

The FDA noted:

The FDA is cautioning pet owners that a sample of Darwin’s Natural Pet Products beef dog food made by Arrow Reliance, Inc. tested positive for Escherichia coli (E. coli) O157:H7 that is associated with a human illness. In addition, one sample of Darwin’s chicken dog food and one sample of Darwin’s duck dog food tested positive for Salmonella Infantis and Hadar, respectively. Closed product from the three affected lots, which were obtained from the household freezer of the ill human, was tested by a private third-party laboratory in May and June 2025.
In August 2024, a four-year-old child became infected with E. coli O157:H7 and subsequently developed hemolytic uremic syndrome (HUS), requiring hospitalization and extensive follow-up care. Whole genome sequencing (WGS) provided by the third-party laboratory shows that the E. coli O157:H7 present in the closed product sample of the Darwin’s beef dog food from the household freezer is a genetic match to the E. coli O157:H7 detected in a stool sample from the ill child.
According to complaint information provided to the FDA, a dog in the household that exclusively ate Darwin’s pet food began vomiting one day before the child fell ill. The dog’s symptoms resolved without veterinary care.
The child had direct contact with the family dog but no known direct contact with the contaminated dog food, suggesting that the E. coli O157:H7 exposure may have been via contact with the family dog or through objects or surfaces in contact with the waste of the dog that ate the food.
Because this incident occurred in 2024, there were no retail samples available for collection and testing when the complaint information and private laboratory results were submitted to the FDA in June 2025. Additionally, Darwin’s Natural Pet Products does not have samples from the same product lot available for additional testing. Therefore, the FDA reviewed the results of the third-party testing conducted by the lab, which is accredited by the FDA Laboratory Accreditation for Analyses of Foods (LAAF) program.
Darwin’s Natural Pet Products are sold online through a subscription service.
The FDA recommended that Arrow Reliance, Inc. recall the product lots that tested positive for E. coli O157:H7 and Salmonella. To date, the firm has not recalled the affected products. These products, which were manufactured in May or June 2024, were sold frozen, have no expiration date on the label, and could still be in consumers’ freezers. Therefore, the FDA advises consumers to check their freezers for the affected lots of Darwin’s Natural Pet Products prior to feeding to pets.
If consumers have any pet food on the list below, they are advised to throw it away in a secure container. Do not feed it to pets. Do not donate the food.

In summary, IEH Laboratories & Consulting Group, an FDA accredited laboratory, isolated E. coli O157:H7 in an unopened package of Darwin’s Natural Pet Products pet food obtained from the Ruiz home. The isolate was a genetic match by WGS to an E. coli O157:H7 isolate obtained from Noah Ruiz. These results prove beyond reasonable doubt that Noah Ruiz acquired his E. coli O157:H7 infection as a result of his exposure to Darwin’s Natural Pet Products.

The precise transmission pathway by which Noah Ruiz acquired the E. coli infection, however, cannot be definitively determined. While direct contact with Rodeo or Darwin’s raw pet food is one viable route, it is equally plausible that exposure occurred through any number of indirect and environmental pathways. These include, but are not limited to, contact with liquids or juices from the raw product; contaminated packaging; surfaces onto which such packaging was placed; and cross-contamination during handling or disposal, including contact with household trash. Additional potential vectors include kitchen and food-preparation surfaces—such as countertops, sinks, faucets, and handles–as well as contaminated utensils, including pet bowls, sponges, and cleaning cloths. Once introduced, pathogens like E. coli can persist and spread throughout the broader kitchen environment—including floors, tables, and “splash zones”—and beyond.

The risk of environmental contamination is not confined to the kitchen. Rodeo was fed in the family’s laundry room, his food was thawed in the household refrigerator, and his bowl was cleaned in the family dishwasher. These practices created multiple potential routes of transmission between pet-related items and human food items, utensils, and shared household surfaces.

The evidence further establishes that Rodeo had been fed Darwin’s raw pet food exclusively since a very young age, resulting in the continuous and repeated introduction of raw animal product into the home environment. This was an ongoing condition that increased the likelihood of environmental contamination over time.

Young children are particularly vulnerable to indirect exposure pathways. They frequently crawl, play on floors, and place their hands or objects in their mouths. Contaminants present on floors and other household surfaces can be readily spread through foot traffic and normal movement within the home, significantly expanding the scope of exposure beyond the initial point of contamination.

Presence and Regulation of Pathogens in Animal Foods

The U.S. Food & Drug Administration (FDA) monitors biological contaminants in animal food, including E. coli, Salmonella, and Listeria monocytogenes. As the FDA notes:

These pathogens may present a hazard to animal health when animals consume contaminated food, and to human health by consumption of contaminated animal products, or by direct exposure to the contaminated animal food capable of causing disease in humans.^[1]

According to the FDA, “[p]athogenic E. coli are bacteria associated with foodborne illness in humans and animals.” Pathogenic E. coli bacteria “can infect animals through consumption of E. coli-contaminated animal food, and humans can be infected by handling such animal food or infected animals and their feces.”^[2] The FDA has specifically addressed “[p]et foods contaminated with E. coli O157:H7,” stating that they are “of particular public health importance because they can affect both human and animal health. Pets can get sick from E. coli O157:H7 . . .and may also be carriers of the bacteria and pass it on to their human companions without appearing to be ill.”^[3]

Further, the FDA’s Center for Veterinary Medicine has previously stated that the “FDA does not believe raw meat foods for animals are consistent with the goal of protecting the public from significant health risks, particularly when such products are brought into the home and/or used to feed domestic pets. . . .”^[4] The FDA has advised the public that the “Federal Food, Drug, and Cosmetic Act requires that all animal foods, like human foods, be safe to eat, produced under sanitary conditions, contain no harmful substances, and be truthfully labeled.”^[5]

In 2015, the FDA adopted a rule titled “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventative Controls for Food for Animals.” 21 C.F.R. Part 507 (2015). For facilities that manufacture, process, pack, or hold animal food, the rule mandates, among others, that “[r]aw materials” . . . must be . . . constructed in a way that protects against contamination and deterioration, and held under conditions, e.g., appropriate temperature and relative humidity, that will minimize the potential for growth of undesirable microorganisms and prevent the animal food from becoming adulterated.” 21 C.F.R. § 507.25(b)(3).

In its recent Guidance for the Industry concerning “Hazard Analysis and Risk-Based Preventive Controls for Food for Animals,” the FDA listed pathogenic E. coli as a known or reasonably foreseeable hazard:^[6]

In its Guidance, the FDA also noted that “[d]ogs and cats with foodborne illness caused by pathogenic E. coli can be asymptomatic or have symptoms ranging from mild gastroenteritis to hemorrhagic diarrhea.”^[7] The FDA also referenced a “study conducted to evaluate the prevalence of microbial organisms in various types of pet food [which] found strains of non-O157:H7 Shiga toxin-producing E. coli in some raw pet food and jerky type treats (Ref. 12).”^[8]

The FDA and state public health agencies “perform risk-based inspections to ensure that animal food, including pet food, is manufactured, processed, packed, and held in a manner that prevents contamination or adulteration of the pet food.”^[9] When a pet food facility is not in compliance, FDA “encourages voluntary corrective actions”; when those cannot be achieved, the FDA utilizes compliance enforcement tools, including advisory actions (such as warning letters) and administrative or judicial actions.^[10]

Darwin (Arrow Reliance)’s History of Repeated and Continued Violations of Food Laws

Arrow Reliance manufactures raw dog and cat food products at a facility in Tukwila, Washington. It advertises that its products use “Human-Grade Ingredients” that are “fresh, whole USDA-quality ingredients” and that such ingredients, and subsequent finished product, are “[m]inimal[ly] process[ed]” and raw.^[11] Arrow Reliance emphasizes the uncooked nature of its finished product: “When we say raw, we really mean it. We do as little as possible to process your pet’s meals….”^[12] Despite obvious risks of contamination, Arrow Reliance, at all relevant times, well knew that its product was frequently used in homes where small children were present, and could foreseeably be harmed from contaminated dog food.

Arrow Reliance has a long history of violating pertinent food laws and regulations. To date, the FDA issued six inspection citations to the Arrow Reliance: two for violating the Federal Food, Drug and Cosmetic Act and four for violating FDA regulations. To illustrate, in 2022, the FDA found that the Arrow Reliance violated the federal legislation because its “animal food bears or contains a poisonous or deleterious substance which may render it injurious to health” and the animal food was “prepared, packed, or held under unsanitary conditions.”^[13] The full list of Arrow Reliance’s citations and their descriptions follows:

Further, Arrow Reliance’s products have been repeatedly recalled due to pathogenic contamination (Class I recalls).^[14] To date, sixteen products were recalled:

The FDA issued two Warning Letters to the Arrow Reliance, one in 2018 and one in 2023. The 2018 Warning Letter noted that the FDA, during its inspections of Arrow Reliance’s facility, found that Arrow Reliance’s “raw pet food products revealed they were contaminated with Salmonella, Listeria, and/or Shiga toxin-producing Escherichia coli O128.”^[15] The FDA concluded that the Arrow Reliance violated the Federal Food, Drug, and Cosmetic Act:

Your raw pet food products are food under section 201(f) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(f)], because they are articles used for food for animals. Based on the analytical results, these products are adulterated under section 402(a)(1) of the Act, which states that food is deemed to be adulterated if it bears or contains a poisonous or deleterious substance which may render it injurious to health. The introduction or delivery for introduction into interstate commerce of an adulterated food violates section 301(a) of the Act [21 U.S.C. § 331(a)].^[16]

In the 2018 Warning Letter issued to the Arrow Reliance, the FDA stated that “[t]he presence of pathogens in pet food results in pet food being adulterated when the pathogen may result in adverse health effects to animals consuming the pet food and/or humans handling the pet food.”^[17] In that same letter, the FDA clearly explained that raw foods present a significant risk to human health and outlined the actions that the Arrow Reliance should take:

Unlike other human and pet foods which are heat-treated or are intended to be cooked, raw pet food has the potential to pose a significant risk to human and animal health because raw pet food is produced with minimal processing and is intended to be handled by humans and fed to animals without cooking, which would kill potentially harmful pathogens. It is therefore essential that your firm has a food safety system in place to prevent and control contamination of your products and facility. Aspects of such a system may include: proper implementation and review of cleaning and sanitization procedures, review and/or testing of your incoming materials and outgoing products, review and/or testing of your facility and environment for possible contamination, a kill step to destroy microorganism contamination, and root cause investigation and corrective action procedures when problems arise. It is your responsibility to ensure that your procedures and overall system adequately prevent, control, and respond to contamination so that you are producing an unadulterated product.^[18]

The 2023 Warning Letter again found Arrow Reliance’s sampled food products, this time for cats, “to be adulterated in that they bear or contain a poisonous or deleterious substance which may render them injurious to health.”^[19] In response to Arrow Reliance’s objections, the FDA reiterated in its 2023 Warning Letter that “the FDA is responsible for protecting the public (human and animal) health by ensuring, among other things, the safety of the nation’s food supply.”^[20] It further stressed that the association between Salmonella-contaminated pet food and salmonellosis is well-established and that the “FDA considers a pet food to be adulterated if it is contaminated with Salmonella, regardless of the quantity or Salmonella serotype.”^[21]

The FDA has also issued numerous advisories concerning Arrow Reliance’s products. As a result, it was always foreseeable to Arrow Reliance that its contaminated food posed a danger to pet owners’ families. For instance, in October 2023, FDA issued an advisory warning consumers to cease use of certain of Arrow Reliance’s raw animal food product after certain of Arrow Reliance’s product tested positive for Salmonella. In September 2024, certain of Arrow Reliance’s raw dog and cat food tested positive for Salmonella and Listeria monocytogenes. FDA advised consumers to discard those lots that tested positive for the bacteria. Arrow Reliance failed to initiate a recall for the affected product, despite FDA’s recommendation to do so, and despite the fact that transmission of pathogens from the affected product was foreseeable.

On July 29, 2025, the FDA issued an advisory concerning the product at issue here action, wherein it referenced the case of the Noah.^[22] Specifically, in the July 2025 advisory, the FDA “caution[ed] pet owners that a sample of Darwin’s Natural Pet Products beef dog food made by Arrow Reliance, Inc. tested positive for Escherichia coli (E. coli) O157:H7 that is associated with a human illness.”^[23] The advisory specifically referenced Noah:

In August 2024, a four-year-old child became infected with E. coli O157:H7 and subsequently developed hemolytic uremic syndrome (HUS), requiring hospitalization and extensive follow-up care. Whole genome sequencing (WGS) provided by the third-party laboratory shows that the E. coli O157:H7 present in the closed product sample of the Darwin’s beef dog food from the household freezer is a genetic match to the E. coli O157:H7 detected in a stool sample from the ill child.^[24]

While the FDA recommended that Arrow Reliance recall the product lots that tested positive for E. coli O157:H7 (and Salmonella), the firm “has not recalled the affected products” to date.^[25] The FDA therefore advised consumers to throw the affected products away, to not feed them to the pets, and to not donate them.^[26]

Further, in the July 2025 advisory concerning the subject Arrow Reliance product, the FDA addressed why it was concerned about pathogenic contamination of pet food.

Why is the FDA concerned about E. coli O157:H7 and Salmonella in pet food?

Pet foods contaminated with E. coli O157:H7 and Salmonella are of particular public health importance because they can affect both human and animal health. Pets can get sick from E. coli O157:H7 and Salmonella and may also be carriers of the bacteria and pass it on to their human companions without appearing to be ill. In addition to the recent child case of HUS associated with pet food contaminated with E. coli O157:H7, FDA is aware of cases in which humans and/or animals have gotten sick from exposure to Salmonella-contaminated pet foods.

The Federal Food, Drug, and Cosmetic Act requires that all animal foods, like human foods, be safe to eat, produced under sanitary conditions, contain no harmful substances, and be truthfully labeled. Refrigeration or freezing does not kill E. coli O157:H7 or Salmonella.

^[1] U.S. Food & Drug Admin., Biological contaminants, https://www.fda.gov/animal-veterinary/biological-chemical-and-physical-contaminants-animal-food/biological-contaminants (last visited on Mar. 30, 2026).

^[2] Id.

^[3] Id.

^[4] U.S Food & Drug Admin., CVM Issues Assignment to Collect Official Samples of Raw Foods for Dogs or Cats in Interstate Commerce in the United States and Analyze them for Salmonella, Listeria monocytogenes, Escherichia coli O157:H7 and Non O157:H7 Shiga Toxin-Producing Escherichia coli (STEC)(June 3, 2015), https://www.fda.gov/animal-veterinary/biological-chemical-and-physical-contaminants-animal-food/cvm-issues-assignment-collect-official-samples-raw-foods-dogs-or-cats-interstate-commerce-united.

^[5] U.S. Food & Drug Admin., FDA Advisory: Do Not Feed Certain Lots of Darwin’s Natural Pet Products Pet Food Due to E. coli O157:H7 and Salmonella (July 29, 2025), available at https://www.fda.gov/animal-veterinary/outbreaks-and-advisories/fda-advisory-do-not-feed-certain-lots-darwins-natural-pet-products-pet-food-due-e-coli-o157h7-and; see also U.S. Food & Drug Admin., Pet Food, https://www.fda.gov/animal-veterinary/animal-foods-feeds/pet-food (last visited on Mar. 30, 2026).

^[6] U.S. Food & Drug Admin., Guidance for the Industry: Hazard Analysis and Risk-Based Preventive Controls for Food for Animals, #245 Section 3.2 (July 2022), available at https://www.fda.gov/media/110477/download?attachment.

^[7] Id. at 31.

^[8] Id. at 32.

^[9] U.S. Food & Drug Admin., Pet Food, https://www.fda.gov/animal-veterinary/animal-foods-feeds/pet-food (last visited on Mar. 30, 2026).

^[10] Id.

^[11] www.darwinspet.com

^[12] Id.

^[13] U.S. Food & Drug Admin., FDA Dashboard: Arrow Reliance, Inc., https://datadashboard.fda.gov/oii/firmprofile.htm?FEIs=3007652252&/identity/3007652252 (last visited on Mar. 30, 2026).

^[14] Id.

^[15] Warning Letter, Arrow Reliance, Inc., MARCS-CMS 547381, April 2, 2018 https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/arrow-reliance-inc-547381-04022018.

^[16] Id.

^[17] Id.

^[18] Id. (emphasis added).

^[19] U.S. Food & Drug Admin., Warning Letter Issued to Arrow Reliance, Inc., MARCS-CMS 644947 — February 16, 2023, https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/arrow-reliance-inc-644947-02162023.

^[20] Id.

^[21] Id.

^[22] U.S. Food & Drug Admin., FDA Advisory: Do Not Feed Certain Lots of Darwin’s Natural Pet Products Pet Food Due to E. coli O157:H7 and Salmonella (July 29, 2025), https://www.fda.gov/animal-veterinary/outbreaks-and-advisories/fda-advisory-do-not-feed-certain-lots-darwins-natural-pet-products-pet-food-due-e-coli-o157h7-and.

^[23] Id.

^[24] Id.

^[25] Id.

^[26] Id.

Canadian Salmonella outbreak blamed on unspecified dog food / dog treats

The Public Health Agency of Canada (PHAC) is alerting residents to an outbreak of Salmonella Oranienburg infections linked to contact with dog food and dog treats.

The PHAC has received reports of 27 laboratory-confirmed cases spread across four provinces and territories: Alberta (13), British Columbia (12), Ontario (1), and Northwest Territories (1).

Six people have been hospitalized.

Outbreak victims range from 0 to 87 years of age, and became sick between mid-February and mid-August 2025. There have been no deaths.

Although many of the victims reported handling dog food and treats prior to becoming ill, including kibble and dehydrated and freeze-dried treats, a common source or supplier has not been identified as yet.

Pet food / pet treat regulation in Canada

Unlike the United States, the United Kingdom, and member countries of the European Union, Canada does not regulate or monitor the microbiological safety of pet foods or pet treats made in Canada for domestic consumption.

Only those Canadian-made pet foods/treats manufactured for export are subject to regulation.

The PHAC has investigated a number of outbreaks of human illness linked to pets, pet foods and pet treats in the past, including illnesses linked to raw pet foods, kibble, pet treats, and feeder rodents for snakes.

What the public should do

This outbreak investigation is ongoing.

To reduce your risk of becoming ill from contact with a dog, their food or treats, the PHAC recommends the following actions:

Always wash your hands thoroughly with soap and water immediately after handling any type of dog food or treat.
Teach children to wash their hands thoroughly, with soap and water, every time after touching dogs, their food or treats.
Wash and sanitize any containers, utensils and surfaces that have come into contact with dog food or treats before using them again. This includes food and water bowls, countertops, microwaves and refrigerators.
Use dedicated dishes and utensils to serve your dog and wash them separately from other dishes and utensils.
Store all dog food and treats away from where human food is stored or prepared and away from reach of young children. Pick up food and treats containers when your pet is done with them.
Follow storage instructions found on the packaging of dog food and treats, including proper refrigeration and freezing if needed, to prevent them from becoming spoiled.
Read the labels on dog food and treats to learn about the ingredients, the product’s expiry date, and if the food is cooked or raw. Raw pet food and treats may be fresh, frozen, dehydrated or freeze-dried.
Wash your hands after contact with a dog and after handling their waste.

“A complete and compelling account of the hidden and not-so-hidden ways the food we give our beloved pets can be contaminated.” – JoNel Aleccia, Health Reporter, Food & Nutrition, The Associated Press.

“An invaluable resource for busy pet owners” – Food Safety News

Order TOXIC now from your preferred on-line retailer

Manufacturer repeatedly shipped pet food after presumptive-positive pathogen test results

April 13, 2025

During the 2024 calendar year, Morasch Meats, Inc. (Portland, OR) sold dozens of batches of Northwest Naturals raw pet foods and pet treats after the finished products tested presumptive-positive for Salmonella or Listeria monocytogenes.

Instead of confirming the presumptive result as required by the test kit manufacturer, the company repeated the same rapid test on fresh samples. When the repeat test did not find the pathogen, Morasch released the production batch for sale.

This information came to light during an Establishment Inspection performed December 27, 2024 through February 7, 2025 in response to a consumer complaint of a cat that had contracted bird flu after consuming a Northwest Naturals pet food. The Inspectional Observations report (FDA Form 483) was obtained by eFoodAlert in response to a Freedom of Information Act request.

Background

Morasch Meats, Inc. processes and packages meat for human consumption (under USDA inspection), and manufactures ready-to-eat raw pet foods and treats for dogs and cats.

In March 2018, the FDA conducted an inspection of the company’s pet food production facility in response to a finding of Listeria monocytogenes in a sample of Northwest Naturals Chicken and Salmon pet food chubs. The inspector found no objectionable conditions, and the inspection was classified as “No Action Indicated.”

In May 2024, an FDA investigator conducted an unannouced routine compliance inspection of Morasch’s pet food operations. Once again, the inspection was classified as “No Action Indicated.”

On December 20, 2024, the FDA was alerted by the Oregon Department of Agriculture (ODA) to the death (by euthanasia) of a three year old cat that had become infected with bird flu. The necropsy report summarized the diagnosis as: “severe necrotizing meningoencephalitis, bronchiolar necrosis to necrotizing bronchiolitis, and rare hepatic necrosis due to highly pathogenic avian influenza (HPAI).”

The ODA collected samples of the open package of Northwest Naturals Turkey Recipe raw cat food that had been fed to the cat. Molecular testing (PCR tests) detected the presence of Influenza A H5N1 nucleic acid in the pet food.

On December 27, 2024, the FDA initiated a new investigtion of Morasch Meat’s pet food operations. That investigation was completed on February 7, 2025.

What the FDA found

In contrast to the May 2024 plant visit, the most recent inspection revealed a pattern of sloppy labwork on the part of the company.

Standard practice when using a test kit to detect pathogens is to begin with an enrichment culture (to allow the pathogen to reach a level that can be detected by the kit).

If the enrichment culture tests negative, all is well. But, if the test kit result is positive (ie., presumptive positive), the enrichment culture is supposed to be processed through conventional test methods to confirm that positive result.

Instead, the company discarded the presumptive positive enrichment cultures in favor of repeating the test kit on a new sample from the same production lot. When the repeat samples tested negative, the company ignored the first (positive) test results and released the products for distribution.

On reviewing the company’s lab test records, the FDA investigator documented dozens of occasions during the 2024 calendar year where the company released product that had previously tested positive for Salmonella or Listeria monocytogenes. These included (quoted verbatim from the FDA Form 483):

“At least 27 batches of frozen finished products tested [redacted] had a presumptive positive for the presence of a pathogen. The same batches were re-tested with a negative result…You explained these products were distributed into commerce without any additional processing to eliminate potential pathogens.”
“Your finished product testing for 2024 shows at least [redacted] batches of frozen finished products were tested [redacted] with presumptive positive pathogen (Salmonella or Listeria monocytogenes) results. These batches were retested [redacted] and all [redacted] from the initial [redacted] had negative pathogen results. You explained these products were distributed into commerce.”
“Your finished product testing for 2024 shows you had at least 109 batches of [redacted] products tested [redacted] with presumptive positive pathogen [E. coli O157:H7, Salmonella or Listeria monocytogenes) results. These batches were retested [readacted], and all [redacted] batches from the initial [redacted] had negative pathogen results. You explained these products were distributed into commerce.”

The inspector highlighted in her report that the manufacturing test kit instruction insert states, “Presumptive positive samples should be confirmed as per the laborator standard operating procedures or by following the appropriate reference method confirmation.” This instruction is consistent with standard FDA laboratory procedures as laid out in the agency’s Bacteriological Analytical Manual.

The company’s records also documented at least 20 locations in the production plant that were found to be positive for Salmonella or Listeria monocytogenes during the 2024 calendar year.

In addition to the persistent problem of pathogen contamination in the production environment and in finished products, the FDA inspection revealed several other concerns, all of which were documented in the Form 483 report. These included:

Condensate from the ceiling and from equipment dripping directly onto ready-to-eat finished products
Wood pallets in poor repair
Employees moving from handling processing equipment to touching finished product without changing gloves
Employees not washing hands
Deep gashes and missing sections in the area of the metal chopper, with areas with direct food contact filled with product during production and between batch runs.
Vitamin and mineral toxicities of concern were not identified in the hazard analysis
Drug residue concerns were not identified in the hazard analysis

The company’s response

The company acknowledged the validity of the FDA’s observations in a written response in which it promised:

“When conducting tests, we will count the first test as a positive result and not retest. We will use our validated interventions as necessary to accomplish a negative result. The product will be retested after the intervention and results will be logged.”
“When conducting environmental sampling for pathogens and the result of a test is positive, we will conduct a corrective action to determine cause and retest to confirm results.”
“Test procedures have been implemented to Homogenize thoroughly.”
“Vitamin and mineral toxicity have been added to the hazard analysis at the rework step.”

Morasch’s response claimed that the various sanitation observations were addressed during the inspection.

Unanswered questions

During the May 2024 inspection, the FDA investigator noted that “Finished pet food product is released for distribution after microbiological analyses results are cleared.” This same investigator also reported having reviewed the environmental monitoring records for the firm’s sanitation program. How did he miss the all of those positive pathogen results?
Duriung the May 2024 inspection, the FDA investigator did a “walk-through” of the production plant. How did he miss the physical deficiencies (dripping condensate, etc.) that were found only a few months later by a different FDA inspector?
This facility is under daily oversight by the USDA. How were the physical deficiencies described in the FDA 483 report allowed to persist?

A final word

It is a food safety axiom that a negative retest does not cancel out a previous positive result on the same production batch.

Bacteria are not distributed uniformly through a solid food. Especially for low-level pathogen contamination, it is quite common for two different samples from the same batch to produce opposite results.

The use of “retest and release if negative” has been proven over and over again to be not just poor practice.

It is downright dangerous.