Powdered Infant Formula linked to infant botulism outbreak

The FDA, CDC, California Department of Public Health and state and local partners are investigating a ten-state outbreak of infant botulism that has sickened 13 infants so far.

Caregivers for all thirteen infants reported feeding ByHeart Whole Nutrition infant formula.

Illnesses have been reported in Arizona (1), California (2), Illinois (2), Minnesota (1), New Jersey (1), Oregon (1), Pennsylvania (1), Rhode Island (1), Texas (2), and Washington (1). These totals include both suspected and confirmed cases.

The thirteen victims range in age from 16 to 157 days. All thirteen have been hospitalized and treated with BabyBIG®, an antidote to infant botulism.

Several states have collected leftover samples of infant formula for testing; work is in progress, but the results are not yet available.

The FDA has recommended that the manufacturer, ByHeart Inc., initate a recall. The company has complied and is recalling the following two lots, which were reported to have been consumed by the infants:

  • ByHeart Whole Nutrition Infant formula:- Lot no. 206VABP/251261P2 and Lot no. 206VABP/251131P2)

Infant botulism happens when swallowed spores from a type of bacteria called Clostridium botulinum infects a baby’s large intestine and make toxin in it. 

Infant botulism often starts with constipation but is usually first noticed as difficulty feeding (sucking and swallowing), a weak and altered cry, and loss of muscle tone. Symptoms can progress to difficulty breathing and respiratory arrest.

Symptoms of infant botulism, which is diagnosed clinically, can take as long as several weeks to develop following formula ingestion.

  • Parents and Caregivers should not use certain lots of ByHeart Whole Nutrition Infant Formula and should throw this product away immediately. If your child is experiencing symptoms (see below) after consuming ByHeart Whole Nutrition Infant Formula and you still have the formula in your home, please record the information on the bottom of the package before throwing it away.
  • Botulism can be fatal, and you should take action right away. If your child has consumed ByHeart Whole Nutrition Infant Formula and is experiencing signs and symptoms of botulism such as poor feeding, loss of head control, difficulty swallowing, or decreased facial expression, seek immediate health care. 
  • If you are a Physician and suspect your infant patient has botulism, immediately call 510-231-7600 for case consultation. Consultation is available 24/7.

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Chapter 6. Birth of a Pathogen

Salmonella and Chicken — Bad Mix

“The fact is, if you make salmonella contamination expensive, if recalls exist and people feel embarrassed that they’re producing food that is making people sick or killing them, they’ll want to change their behavior,” Marler said.

Susanne Rust of the LA Times writes: “Poultry industry pushes back as food safety group cites salmonella contamination”                                   

                  •               A new report reveals salmonella is widespread in U.S. poultry production, with major brands like such as Costco regularly exceeding federal safety limits.

                  •               The USDA lacks authority to enforce salmonella standards or halt sales; inspectors can only note violations.

                  •               When the government reclassified E. coli into a more serious category, there were more recalls and fewer cases of illness.

A new report based on government inspection documents shows salmonella is widespread in U.S. grocery store chicken and turkey products. But because of how the pathogen is classified, the federal government has no authority to do much about it. 

Farm Forward, an organization that advocates for farmworker rights and humane farm practices, released a report this week that examined five years of monthly U.S. Department of Agriculture inspections at major U.S. poultry plants. It found that at many plants, including those that process and sell poultry under brand names such as Foster Farms, Costco and Perdue, levels of salmonella routinely exceeded maximum standards set by the federal government. 

“The USDA is knowingly allowing millions of packages of chicken contaminated with salmonella to be sold in stores from major brands,” said Andrew deCoriolis, the organization’s executive director.

Some 1.3 million Americans are sickened each year by eating salmonella-contaminated food, according to the U.S. Centers for Disease Control and Prevention. Most people have only mild symptoms, but others suffer diarrhea, nausea and vomiting. Roughly 19,000 people are hospitalized annually, and an estimated 420 die from the infected food. 

Chicken and turkey account for nearly a quarter of all salmonella infections, according to a 2021 government report on food illness.

The USDA’s Food Safety and Inspection Service inspects poultry plants monthly. The new report shows that five U.S. poultry plants exceeded maximum allowable salmonella contamination every month from 2020 to 2024. These included a Carthage, Mo., turkey plant owned by Butterball, a Dayton, Va., turkey plant owned by Cargill Meat Solutions, and a chicken plant located in Cunning, Ga., that is owned by Koch Foods. A Costco chicken producer, Lincoln Premium Poultry, exceeded the standard in 54 of 59 inspections.

“Lincoln Premium Poultry treats the safety of its products as an utmost concern,” Jessica Kolterman, the company’s director of administration, said in an email. “When the United State Department of Agriculture reports are updated and published, they will show that we have enhanced our standing. … We will continue to improve our processes.”

A spokesperson for Butterball said the company “takes food safety very seriously and follows all USDA and FSIS regulations and inspection protocols.” The spokesperson said facilities are subject to rigorous, continuous oversight, and they are “constantly reviewing and improving our food safety programs to ensure we meet or exceed government standards.”

Cargill, Perdue and Koch Foods did not reply to requests for comment. Foster Farms directed questions to the National Chicken Council, the industry’s trade group. 

“Consumers should not be concerned,” said Tom Super, a spokesman for the chicken council. He said the report was “unscientific” and described Farm Forward as an “activist organization whose stated goal is to end commercial chicken farming.”

Both Super and Bill Mattos, president of the California Poultry Federation, said poultry is safe when cooked to 160 degrees, and knives, cutting boards and other items that may have come into contact with raw meat are disinfected and cleaned.

“All chicken is safe to eat when properly handled and cooked,” said Mattos, noting that annually “Californians eat more chicken than any other state … 110 pounds per person!”

The report also suggests that the federal government’s standards for acceptable levels of salmonella are unduly high, and potentially put American poultry consumers at risk. 

For ground chicken, the USDA allows 25% of samples at a plant to be contaminated. For ground turkey, 13.5%. Chicken parts should not exceed 15.4% of samples contaminated, while the number is 9.8% for whole chickens. 

“I don’t know, but seems common sense to me that if you allow for a lot of salmonella, a lot of people are going to get sick,” said Bill Marler, an attorney with Marler Clark, a national food safety law firm.

When inspectors visit a plant, they do not assess the meat’s bacterial load, nor do they determine the strain of bacteria found on the product. They just test for the presence of the bacterium — it’s either there or it’s not.

According to Marler and Maurice Pitesky, a poultry science expert at UC Davis, there are hundreds of strains — or serotypes — of Salmonella. Most are considered harmless, but roughly 30 are known to be potentially lethal to people.

As a result, the USDA inspections don’t give a clear picture about what’s there, Pitesky said. 

“When I hear something has salmonella, I’m like, ‘OK, first question: I want to know its serotype. What kind of serotype is it?’ Because that that’s really the relevant piece of information,” he said.

When inspectors find a plant has exceeded the salmonella standard, there is very little they can do except note it. The agency has no authority to enforce the standards.

Marler said in the 1990s, after four children died and hundreds of people got sick eating ground beef contaminated with E. coli sold at Jack in the Box restaurants, the agency decided to classify the bacterium as an adulterant. That designation meant the USDA could stop the sale of contaminated products, or shut down a plant that failed inspections. 

He said the beef industry initially pushed back, fearing it would lose money — which it did, at first.

He said the USDA started doing retail testing, “and for a while, it felt like there was a recall a week — you know … 50, 100, a thousand pounds here, a million pounds there, even 10 million pounds.” Eventually, however, companies started testing their products “and coming up with interventions to get rid of it. And you know what? The number of E. coli cases linked to hamburger plummeted.”

He said now he sees a case only once in a while.

“I kind of look at that and think, well, if you get salmonella out of chicken, you’ll probably reduce those cases too,” he said.

Pitesky said that salmonella is notoriously difficult to get rid of. It can be introduced to flocks from wild animals, such as birds, rats, mice and other wildlife. It’s also found in the intestines of chickens, on their skin, feathers and feet, and it spreads among them when they poop, urinate and walk around in shared bedding, etc.

However, Marler thinks it can be controlled.

“Yeah, it’s difficult,” he said. “But you can do a lot of things. And this might piss people off, but you could eradicate flocks with salmonella. They do it in the EU all the freaking time.”

The European Union considers salmonella an adulterant, and require producers to reduce and control it via biosecurity, testing, vaccinations, recalls and occasionally depopulation.

“The fact is, if you make salmonella contamination expensive, if recalls exist and people feel embarrassed that they’re producing food that is making people sick or killing them, they’ll want to change their behavior,” he said.

This post by William Marler first appeared on Marler Blog on October 30, 2025, and is reposted here with permission.

OP-ED: It’s time for states to step up for food safety

Donald Trump and his acolyte, RFK, Jr., vowed to “Make America Healthy Again.”

They lied.

Watch what they do, not what they say.

Rachel Maddow, MSNBC host
  • RFK, Jr. fired every single member of FDA’s media communications team, including its director.
  • The proposed 2026 budget for the FDA outlines plans to shift the responsibility for routine food safety inspections to the states.
  • The 2026 FDA budget also proposes an overall reduction in full-time equivalent staffing for the Human Foods Program of 7.6%, with the Office of Investigations and Inspections reduced by 2.0%, and the Field Laboratory Operations by 54.4%.
  • Staff cuts at the FDA have already put the brakes on the agency’s ability to trace the source of foodborne disease outbreaks. In 2024, the agency investigated a total of 26 outbreaks and identified the source of 20 (77%). In 2025, the FDA has closed its investigation of 11 outbreaks after identifying the source of only 4 (36%); an additional 11 investigations remain under investigation, with a food source having been identified in four (36%).
  • The CDC has reduced its active surveillance of foodborne pathogens from six target organisms to just two, claiming lack of funding.
  • RFK, Jr. and Secretary of Agriculture, Brooke Rollins proposed allowing bird flu to “rip through” infected poultry flocks instead of culling the flocks to prevent further spread.
  • The USDA withdrew its proposed rule that, for the first time, would have placed (very lenient) limits on the presence of certain Salmonella strains in raw poultry.
  • Staff cuts at the USDA’s Animal and Plant Health Inspection Service have reduced the agency’s ability to combat livestock diseases, including bird flu.
  • The US Justice Department unit that used to handle drug and food safety cases on behalf of the FDA has been disbanded.
  • The EPA has rolled back clean air standards and eased limits on pesticide use.

What can US consumers expect as a result of these roll-backs?

  • More foodborne disease, including more hospitalizations and deaths
  • More outbreaks going unreported and unsolved
  • Inconsistent food safety inspection standards from state to state

I have been a food safety microbiologist for more than fifty years. I have worked both in government and in the private sector.

During my entire career, I have advocated for a single agency to oversee food safety—an agency with Cabinet-level representation that would replace the current fragmented regulatory system in the United States.

But desperate times require desperate measures. The federal government is not doing its job. Nor does it plan to in the future.

The various states that have the resources to do so must take action to protect their population from the failures of the federal government.

Democrat-led states on both coasts have already acted to counter the CDC vaccine panel’s new recommendations that would restrict access to respiratory (Covid-19, influenza, and RSV), MMRV, and Hepatitis B vaccines.

The West Coast Alliance is comprised of California, Oregon, Washington, and Hawaii. The Northeast Public Health Collaborative includes New York, Pennsylvania, New Jersey, Connecticut, Massachusetts, Maine and Rhode Island, as well as New York City’s Department of Health.

If a state government can override federal recommendations on vaccine access, the state also can superimpose its own food safety regulations on those handed down by the FDA and USDA in order to protect its population from disease.

I propose that the West Coast Alliance be extended to encompass food safety, including the following actions:

  • Develop and implement a common set of inspection standards for produce and processed foods originating in California, Oregon, Washington, and Hawaii.
  • Embargo all shipments of produce and processed foods originating from outside the borders of its member states unless each individual shipment is accompanied by a Certificate of Analysis issued by an accredited laboratory.
  • Regulate discharge emanating from concentrated animal feeding operations (CAFOs) in the member states—discharge that pollutes the soil in which crops are grown and the water used to irrigate those crops.

I am not suggesting these actions will be easy or inexpensive. But, as the federal government no longer appears to be interested in protecting the public from unsafe food, the states that are able to do so must take over.


TAINTED formats 3
“Reads like a true crime novel” – Food Safety News

Interested in learning more about food safety and the history of foodborne disease outbreaks and investigations?

Click on the link to listen to a short excerpt, then follow the buy links to add a digital, print or audio copy to your personal library.

Chapter 6. Birth of a Pathogen