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FDA Quietly Closes Deadly E. coli Outbreak Investigation, Report Highly Redacted

Posted in E. coli,Our Blog,Outbreaks & Recalls on September 30, 2025

An E. coli outbreak investigation that has been ongoing since April was quietly closed in August. Despite nearly a dozen cases, several severe illnesses, and one death, the investigation did not uncover a food source.

The information obtained from the U.S. Food and Drug Administration (FDA) was highly redacted, making sifting through available data difficult.

These illnesses matter.

This death matters.

Here’s what we know so far.

Initial Reports of E. coli Outbreak

In late April, Centers for Disease Control and Prevention (CDC) notified FDA of an identified cluster of E. coli O145:H28 illnesses. On April 28, 2025 there were 11 cases with illness onset ranging from March 25, 2025 to April 9, 2025, says the outbreak’s Investigation Executive Summary Abstract.

The locations of these cases (typically attributed to certain states) is often listed in this type of investigation report. In this case, the information is redacted. Meaning, the report did include this information. But it has been blacked out and is not available to the public.

Sick patients were between the ages of 12 and 45 years old, and mostly (73%) female.

At least 11 confirmed cases were reported with the outbreak strain. Of which, three were hospitalized, one developed a complication known as hemolytic uremic syndrome (HUS), and one died.

This outbreak investigation was published to the FDA’s Active Foodborne Illness Investigation table weeks later, on May 14, 2025

No Other Outbreak Clusters Matched the Outbreak Strain

According to the Outbreak Summary, “no other outbreak clusters or non-clinical isolates” were genetically related to this outbreak strain.

What does that mean?

Certain illnesses, including those known for foodborne illness outbreaks (E. coli, Listeria, Salmonella, etc.) are reported to the CDC.

Patient (and sometimes food) samples undergo a type of genetic testing known as Whole Genome Sequencing (WGS) and that data is uploaded into a database. When more than one case presents the same genetic strain, the CDC and FDA consider this an outbreak cluster.

Generally, this prompts an outbreak investigation.

In this case, the only cases that matched were the 11 indicated in the initial report.

Does this mean there are no other people sick?

Unfortunately, no. There are likely other cases.

Only a Fraction of Illnesses Are Linked to An Outbreak

When it comes to foodborne illnesses, there is a spectrum of symptoms.

Some people only experience mild symptoms. While others experience more severe illness, even requiring hospitalization to recover. Others still never recover and die from their illness.

In this E. coli outbreak, three people required hospitalization and one experienced a life-threatening complication.

Those With Mild Symptoms Usually Do Not Report Illness

In many cases, symptoms are very mild. You’ve got a little bit of nausea. Some diarrhea. You feel bad for a couple of days. Then you are better.

Those are the lucky ones.

The ones that stay home. Hydrate. Sit on the couch or lay in bed until they begin feeling better. Sometimes as early as the next day or in as little as three days.

In these cases, people determine that it is more trouble than it is worth to go to the doctor for their illness. Most of the time, by the time you are able to get to see a doctor, you already feel better.

These cases go unreported.

But this isn’t the only reason illnesses may not end up on the CDC and FDA’s radar.

Not All Illnesses Are Reported to the CDC

Unfortunately, CDC’s FoodNet foodborne illness reporting network does not span the entire country. FoodNet is a collaboration between the CDC, FDA, United States Department of Agriculture (USDA) and ten state health departments. Colorado, Connecticut, Georgia, Maryland, Minnesota, New Mexico, Oregon, Tennessee, and select counties within California and New York state. About 16% of the U.S. population.

Even some of those that do seek medical attention are not reported to FoodNet. Small jurisdictions outside of the participating health departments often do not get included in these outbreak investigations until the cluster becomes large. A handful of illnesses from non-participating states may not make the report.

There are many reasons these outbreaks go unreported.

For example, the patient might not be tested for foodborne illness bacteria when other ongoing illnesses are being treated. Would a doctor treating a patient for chronic IBS test the patient every time they have an office visit? Unlikely.

Additionally, some rural areas may not send samples out for testing. Opting to treat the symptoms instead, and only sending patients to larger cities for severe illness.

The speculated list goes on and on.

For this reason, it is not unreasonable to assume that this outbreak reaches far more than 11 people.

What Caused This E. coli Outbreak?

Isn’t that the number one question? What caused this E. coli outbreak?

Based on the published report summary, there were “no indicators to formulate a hypothesis as to the source or route of contamination for this outbreak.” The outbreak strain was not found in any “retail or inspectional samples.”

But that doesn’t mean they didn’t have their suspicions.

In fact, three “traceback legs” were investigated. The points of sale were redacted, so this information is not publicly available. No specific product could be narrowed down due to lack of “commonalities for the component ingredients” and “limited purchase information.” However, an unnamed food item “remained the suspect vehicle for this outbreak investigation” based on epidemiological evidence.

Outbreak Investigation Came to a Close on June 27, 2025

With the outbreak investigation running out of leads, no new cases, and no new data, the FDA closed the investigation on July 27, 2025. On August 12, 2025 the incident was closed out.

Have You Become Sick with An E. coli Infection?

If you have become sick with an E. coli infection, from this E. coli outbreak or another one, it can be a difficult time.

The symptoms of E. coli infections often begin around three to four days after exposure and may include vomiting, severe stomach cramps, diarrhea (often bloody), and fever less than 101° F (not always). Most normally healthy people generally recover from E. coli infection within five to seven days. Some people, on the other hand, may experience other complications. These complications may lead to hospitalization or even death.

The elderly, young children (under five years), and those with a weakened immune system may experience more severe illness or develop serious complications. Complications like hemolytic uremic syndrome, or HUS. A type of life-threatening kidney failure.

Missed work, medical bills, and other burdens of foodborne illness add up.

The Lange Law Firm Can Help!

If you have become sick in this E. coli outbreak, or another one, it is a good idea to get advice from an experienced E. coli lawyer.

The Lange Law Firm, PLLC has successfully won millions of dollars in products liability and food poisoning cases. They can help you too!

Call (833) 330-3663 or send an email for a free, no obligation consultation.

By: Heather Van Tassell (contributing writer, non-lawyer)