FDA’s internal records on two E. coli O157:H7 outbreaks linked to Raw Farm LLC of Fresno, California, show the agency suspected in February 2024 that Raw Farm was putting milk from cows that had tested preliminary positive for pathogens into its raw cheddar cheese. Two years later, after a second outbreak linked to the same cheese sickened nine people, most of them small children, FDA inspectors documented the practice.

The records, released with Freedom of Information Act redactions, cover CARA #1215, the 2023–2024 outbreak that sickened 11 people in five states, and CARA #1369, the 2025–2026 outbreak, including FDA’s incident logs, closing summaries, a sequencing report, and Health Hazard Evaluations signed in June 2024 and April 2026.

What did FDA know about Raw Farm in 2024?

CDC told FDA’s Coordinated Outbreak Response and Evaluation (CORE) Network about the first cluster on February 9, 2024. It grew to 11 cases in California, Colorado, New Jersey, Texas and Utah. Five people were hospitalized, and two developed hemolytic uremic syndrome (HUS). Seven of the 10 people interviewed reported eating Raw Farm raw cheddar in the week before they got sick, against 4.9 percent in CDC’s FoodNet Population Survey.

FDA’s February 15, 2024, incident briefing says the firm’s own account of its cheesemaking “appears to indicate that the firm uses potentially contaminated milk from cows that have tested preliminary positive for pathogens in their cheese production,” relying on the aging requirement for raw milk cheese. The traceback summary is blunter: “Milk from sick cows was diverted to make raw milk cheddar cheese for both the shredded and block cheeses.” The briefing adds that earlier FDA inspections had found inadequate preventive controls, and that about half of Raw Farm’s cheddar shipped out of state, beyond the reach of the 2010 federal injunction, which covered raw milk but not aged raw cheese.

FDA drafted an assignment to collect shipment and lot code records at Raw Farm itself. It was never issued. The Office of Chief Counsel advised against it “due to ongoing litigation activities and communication challenges with the firm.” The three traceback assignments FDA did issue, to retail and distribution points, were conducted remotely and closed with no Form 483.

Raw Farm recalled certain lots on February 16, 2024. Ten days later it issued a press release withdrawing and concluding that recall. FDA’s consumer advice did not change, and its June 10, 2024, Health Hazard Evaluation found that people who ate the cheese were at high risk of illness that could be fatal. The closing summary concludes, “Although we don’t know how the contamination occurred, Raw Farm-brand Raw Cheddar cheese was determined to be the source of the outbreak.”

CDC flagged the second cluster on March 10, 2026, and named Raw Farm raw cheddar the suspect on March 13. At closure there were nine cases: seven in California and one each in Florida and Texas. The median age was 2. Three people were hospitalized and one developed HUS. All eight people asked reported eating or being served raw milk or cheese, against 6.4 percent in FoodNet, and all seven who knew a brand-named Raw Farm.

The 2026 evaluation explains why cases came in two waves. Three people fell ill in September 2025 after drinking Raw Farm raw milk; the rest fell ill in January and February 2026 after eating Raw Farm cheddar. FDA wrote that milk from the same supply that sickened the first group was likely diverted into cheese without an intervening step, aged, and sold.

What did FDA inspectors find at Raw Farm in 2026?

FDA’s for-cause inspections ran from March 19 into the second week of April 2026, doubling as follow-up under the 2023 Consent Decree, and ended with Form 483 observations at three sites. At the Fowler creamery, FDA found the firm using raw milk that had tested positive for pathogens to make raw cheese and storing raw milk without temperature control. At the Hanford cheese plant, FDA found Raw Farm had never scientifically shown that its aging process controls pathogens, that employees cleaning the processing room spread potential contamination from the floor, and that the firm did not follow its own environmental testing procedures. At the Hanford dairy, FDA saw uncleaned milking equipment, poor hand and glove hygiene, and manure on the teat of a cow being milked.

The incident log adds more. Employees did not change gloves between washing down manure and handling the milking claw. Raw Farm’s pathogen testing protocol did not test its 8-ounce and 16-ounce finished packages, the ones people buy. On the first day of the inspection, Raw Farm reported that it had destroyed seven batches made with positive milk that had tested negative as finished product and had stopped using positive milk for cheese.

Does aging raw milk cheddar kill E. coli?

Not reliably. Federal rules allow cheddar to be made from unpasteurized milk if it is cured at no less than 35°F for at least 60 days. FDA redacted the length of Raw Farm’s aging process. At Hanford, Raw Farm’s own testing found pathogens in cheese that had finished aging, made from milk that first tested negative, which FDA wrote “shows the aging process does not control pathogens in the raw cheddar cheese products.”

The 2026 evaluation names the underlying policy, diverting pathogen-positive milk into cheese without an intervening step, as a contributor to Raw Farm’s outbreaks, because aging “does not guarantee pathogen elimination.” The question was not new; the 2024 briefing notes an earlier FDA outbreak investigation had already asked whether aging eliminates pathogenic E. coli.

Did FDA find E. coli in Raw Farm cheese?

Not the outbreak strain, in either outbreak. In 2026, however, a block of raw cheddar FDA collected at the Hanford plant on March 31 tested positive for a different strain of E. coli O157:H7. Raw Farm said the batch was never distributed. FDA’s April 15 sequencing report matched it to 19 clinical isolates from 2025, three of them within 1 to 8 SNPs, or single-letter genetic differences. Many were tied to a fall 2025 cluster CDC closed without identifying a food. FDA did not count those illnesses in this outbreak because there were no epidemiologic links, and nothing in the released records shows whether those patients were later asked about Raw Farm.

Why did the 2026 Raw Farm recall take three weeks?

The 2026 evaluation lays out the calendar. On March 13, FDA and CDC told Raw Farm its products were linked to the outbreak and asked for a recall decision within 24 hours. On March 14, the firm declined. On March 16, a business whose name FDA redacted issued a recall notice for all Raw Farm raw cheese sold in stores. On March 27, FDA asked again, recommending a recall of all cheese sold or distributed after December 15, 2025. On March 28, Raw Farm asked for more information. It told FDA on April 1 that it would recall, announced the recall April 2, and issued an updated release April 7 covering cheese with expiration dates from May 6 through September 24, 2026.

I wrote in Food Safety News on April 1, while the company was still refusing, that Raw Farm has a long history of outbreaks linked to its products. FDA’s files now tell it in the agency’s own words.

What is Raw Farm’s outbreak history?

My April 1 column traces outbreaks and recalls back to 2006 under Raw Farm and its predecessor, Organic Pastures, including E. coli O157:H7 outbreaks linked to its raw milk in 2006, 2011 and 2016 and to its raw cheddar in 2023–2024 and 2025–2026, and a 2023–2024 raw milk Salmonella Typhimurium outbreak California counted at 171 illnesses. FDA’s 2026 evaluation says the string of recent outbreaks demonstrates “the firm’s systematic potential to produce unsafe fluid raw milk and raw milk cheddar cheese.” Organic Pastures pleaded guilty in 2008 to two misdemeanor counts of introducing misbranded food into interstate commerce, a permanent injunction followed in 2010, and a 2023 Consent Decree gave FDA the right to inspect without notice.

What would have prevented this?

Two rules would have mattered. Milk that tests positive for a pathogen should never become raw milk cheese; Raw Farm told FDA it would stop only during the March 2026 inspection, two years after FDA first wrote down its suspicion. Finished retail packages of raw milk cheese should be tested before they ship; Raw Farm’s protocol did not test them. FDA should write both into its standards for raw milk cheese rather than wait for a third outbreak.

Was Raw Farm raw cheddar cheese recalled?

Yes, twice. Raw Farm recalled certain lots on February 16, 2024, and withdrew that recall ten days later. It recalled its raw cheddar again on April 2, 2026, and expanded the recall on April 7 to cheese with expiration dates from May 6 through September 24, 2026.

FDA Documents

https://www.marlerblog.com/files/2026/09/1369-Records-FInal_Redacted.pdf

https://www.marlerblog.com/files/2026/09/CARA-1215-Records-Final_Redacted.pdf