The Centers for Disease Control and Prevention (CDC), the U.S. Food and Drug Administration (FDA), the Washington State Department of Health (DOH), and officials in three other states are investigating an outbreak of botulism linked to powdered infant formula produced by Nara Organics of New York. 

Three infants in three states have been involved in the outbreak, including one infant in Thurston County, Washington, whose reported illness led to the nationwide recall. All cases included in this outbreak are reported to have consumed the Nara Organics brand powdered infant formula. Nara has voluntarily recalled the formula.

If you have recently purchased formula from Nara Organics:

  • Do not use. Throw it away or return it to where you bought it. If you still have the container, record the lot number before discarding. If you have an open container, refer to the CDC’s recommendations linked below.
  • Wash items and surfaces that may have touched the recalled formula using hot soapy water or a dishwasher.
  • Seek immediate medical care if your infant has consumed Nara Organics Infant Formula and has any of these symptoms:
    • Poor feeding
    • Loss of head control
    • Difficulty swallowing
    • Decreased facial expression

Symptoms of infant botulism can take as long as several weeks to develop, so parents should remain vigilant if they used the recalled lots of infant formula.

Infant botulism is a rare illness that usually affects babies less than six months of age. Babies get ill when bacteria (Clostridium botulinum) they have ingested produce a toxin that can weaken muscles. These bacteria are naturally found in dust, soil, and honey (which should never be given to babies under a year old). It is rare for a commercial infant food product to be linked to an outbreak of infant botulism. This recall is unrelated to a similar recall in November 2025.

Did anyone see this coming? The honest answer is almost always yes. Someone always saw it coming. The tragedy is in who chose not to act.

So let me say plainly what the last seven months have made undeniable. The botulism outbreaks tied to ByHeart and now Nara Organics powdered infant formula were not freak events. They were not bad luck. They were predictable — predictable from the biology of the product, predictable from decades of published science, and predictable from a warning the FDA put in writing and mailed to this entire industry three years ago.

Two outbreaks in seven months.

In November 2025, Clostridium botulinum type A and B spores in ByHeart Whole Nutrition Infant Formula sickened 48 infants across 17 states. Investigators confirmed the link the strongest way there is: whole genome sequencing matched the strain in the whole milk powder to the strain in the finished formula to the strain in the sick babies. The implicated milk came through Organic West Milk and was dried into whole milk powder at a Dairy Farmers of America plant before it ever reached ByHeart. Illnesses began in 2023 and ended in 2025.

Then, in June 2026 — before the ink was barely dry on the ByHeart post-outbreak reports — the FDA and CDC announced a second outbreak. Three more infants, in California, Pennsylvania, and Washington, hospitalized with type A botulism after consuming Nara Organics Whole Milk Organic Powdered Infant Formula, sold nationwide at Target (a majority of the ByHeart cases purchased at Target also). The babies were two to five months old. Their illnesses began in April and May. The finished-product testing is still underway, so for now the link is epidemiologic — but the FDA found the signal serious enough to recommend a recall while that testing continues. Same toxin type. Same kind of product. Same implicated ingredient: whole milk powder.

Two outbreaks, two brands, one ingredient, one pattern. That is not a coincidence. That is a system failing the same way twice.

The science was never a secret.

Here is what every microbiologist who works on this already knew, and what the FDA itself now concedes on its own outbreak page: pasteurization does not kill C. botulinum spores. It was never designed to. Spores are built to survive heat, drought, and time. And whole milk powder is made by taking raw milk, pasteurizing it, concentrating it, and spray-drying it — none of which is lethal to a spore. If spores are in the raw milk, they can ride straight through to the powder, and from the powder into a can of formula.

That the organism can travel the dairy chain is not new science either. The veterinary and food-safety literature has documented for years how C. botulinum moves from contaminated silage into cattle, into raw milk, and onward — and that standard pasteurization does not eliminate the spores along the way. The risk in any single can is low, which is exactly why the industry was allowed to treat it as theoretical. But “low” is not “zero,” and when you are spray-drying 250,000 pounds of whole milk powder a day and shipping it into the most vulnerable population on earth, “low” becomes a certainty waiting for a date on the calendar.

The industry knew this well enough that a single suspected botulism contamination in milk powder triggered a worldwide precautionary recall more than a decade ago. In August 2013, New Zealand’s dairy giant Fonterra initiated a massive global recall after tests incorrectly indicated the presence of Clostridium botulinum in its whey protein concentrate. The ingredient was used in infant formulas and sports drinks. The hazard has been on the radar the entire time. What was missing was not knowledge. It was will.

The warning in writing.

This is the part that should end the debate about foreseeability for good.

On March 8, 2023, the FDA sent a Call-to-Action letter to every manufacturer, packer, distributor, importer, and retailer of powdered infant formula in the country. It was signed by the Commissioner of Food and Drugs and the Director of the Center for Food Safety and Applied Nutrition. It did not bury the issue. It named it:

“Historical associations between powdered infant formula and pathogens such as Cronobacter spp., Salmonella, and Clostridium botulinum should be considered when designing and implementing controls for the safe manufacture of all foods for infants and young children.”

The letter went further. It told the industry the agency had already investigated “infant botulism cases among infants who consumed powdered infant formula from a variety of manufacturers.” This was not a hypothetical the FDA dreamed up. It was a documented history the agency had lived through and was warning the industry to control for.

And the letter spelled out how. One of its five areas of concern was supply-chain controls for biological hazards. In plain terms: if you dry-blend an ingredient into formula and that ingredient never gets a step that kills bacteria, you must evaluate the hazards at your supplier and control them there. That paragraph reads as if it were written specifically about untreated whole milk powder, because that is exactly the kind of ingredient it describes.

So, when ByHeart happened in late 2025, the foreseeability was not a close call. The FDA had named the organism, named the product, named the documented history, and named the control duty — in writing, to the whole industry, more than two and a half years earlier. When Nara happened in 2026, that warning was three years old. Nobody can stand up and say they were blindsided. They were warned, and the warning is a matter of public record.

A recall is not a food safety system

After ByHeart, the FDA had to send warning letters to Target, Walmart, Kroger, and Albertsons because recalled formula was still sitting on shelves — in some cases restocked and discounted — weeks after the recall began. Now we have a second recall, again at Target, of a different brand made with the same kind of ingredient. A recall after babies are already in the hospital is not a food safety system. It is an apology issued too late to matter to the family living it.

I want to know a few things.

I want to know why, after a March 2023 letter that named Clostridium botulinum by genus and species, no one required formula made with untreated whole milk powder to be tested for it before a single can shipped.

I want to know why we are still detecting this toxin only after infants are diagnosed, instead of before the product reaches a store shelf at Target.

And I want to know what, concretely, has changed between the ByHeart outbreak and the Nara outbreak — because from where I sit, representing the families, the answer looks like nothing.

The point.

I am not interested in hindsight. Hindsight is cheap, and the families I represent cannot spend it. What I am interested in is the record — and the record here shows a hazard the science had described for decades, an organism the FDA named in writing in 2023, a control duty the agency spelled out in the same letter, and two outbreaks that followed anyway.

This was foreseeable. It was, in the FDA’s own framing, reasonably foreseeable. And foreseeable harm to infants is the kind of harm a functioning food safety system is supposed to prevent — not catalog after the fact.

I have said for years that my goal is to put myself out of business by making food safe enough that there is nothing left for me to do. Outbreaks like these are the reason I am still working. We were warned. The babies paid anyway. We can do better, and we knew how to do better before the first one ever got sick.

And, irony of ironies – according to Consumer Reports:

“The news of the Nara Organics infant formula recall comes on the heels of another massive outbreak of infant botulism tied to ByHeart infant formula, which led to all ByHeart formula ever produced being recalled as of December 2025. ByHeart formula was eventually linked to 48 cases of infant botulism in 17 states. No deaths occurred. After all ByHeart formula was recalled, ByHeart encouraged its users to switch to Nara Organics with a 20 percent discount “to help and support ByHeart families make a smooth transition to a new formula,” an Instagram post from ByHeart said.”

And, Nara’s own website – Nara even built out its own support pages for incoming ByHeart families:

“As you switch from ByHeart to a new formula, we’ve put together some helpful instructions on how to use feeding equipment that may have been exposed to the recalled formula.”

From Nara Organics:

The health of all babies is our first priority, and for that reason, we’re issuing a voluntary recall for all cans of Nara Organics infant formula currently available in the U.S. 

Stop using all Nara Organics infant formula immediately. 

We are heartbroken for the concern and stress this may cause your family. 

Late on Friday June 12, 2026, the FDA provided epidemiological information to us of 3 cases of infant botulism in babies who the CDC reported had consumed Nara infant formula. As of today, no Nara formula has tested positive for C. Botulinum. We believe in taking the strongest possible measure to protect the safety of babies. That’s why we quickly decided, in an abundance of caution, to voluntarily recall all Nara Organics infant formula currently available in the U.S.

Your family deserves to have complete confidence in the safety of your baby’s food. 

Health Information

If your baby has consumed Nara formula and is presenting symptoms of infant botulism including, but not limited to constipation, poor feeding, ptosis (drooping eyelid), sluggish pupils, low muscle tone, difficulty sucking and swallowing, weak or altered cry, generalized weakness, respiratory difficulty, and possibly respiratory arrest, please contact your healthcare provider for immediate care.

Affected Formula

All cans of Nara Organics Infant Formula are being voluntarily recalled. Stop using all Nara formula immediately. 

We are voluntarily recalling all Nara formula. The three specific product lots these infants were exposed to are: 709125280E14F2, 709125288E14F2, 708125174E14F2.

All Recalled Lot Codes

  • 408125075E14F2
  • 708125076E14F2
  • 708125083E14F2
  • 408125139E14F2
  • 708125141E14F2
  • 708125145E14F2
  • 708125174E14F2
  • 709125273E14F2
  • 709125280E14F2
  • 709125288E14F2
  • 409125307E14F2
  • 70926019ENNB
  • 70926029ENNB
  • 70926035ENNB
  • 70926039ENNB
  • 70926042ENNB

In just seven months, we have had two outbreaks of infant botulism tied to powdered formula made with whole milk powder. First ByHeart in November 2025 — 48 sick babies in 17 states. Then Nara Organics in June 2026 — three more hospitalized in California, Pennsylvania, and Washington. With ByHeart, DNA testing matched the exact strain of bacteria in the milk powder to the finished formula and to the sick infants. With Nara, the link so far is the epidemiology — the same kind of whole milk powder, the same rare illness, in babies who drank it — and testing of leftover formula is still underway. Either way, that is not a coincidence. That is a pattern.

I represent families in ByHeart, so I have a side. But the science here is not a matter of opinion, and the more I have looked at it, the more it troubles me. Here is what every parent should understand.

What happened

Both outbreaks involve organic whole milk powder. In the ByHeart outbreak, investigators confirmed the link the strongest way possible — by matching the exact strain of Clostridium botulinum found in the milk powder, in the finished formula, and in the sick babies. In the Nara outbreak, the link is so far epidemiologic: three infants who consumed the formula developed the same type A botulism, and FDA recommended the recall based on the severity of the illnesses and that signal while testing continues. ByHeart recalled all of its products in November 2025. Nara recalled all of its lots in June 2026. Thankfully, no babies died, but all were hospitalized and treated with BabyBIG, the special antitoxin used for infant botulism.

This kind of thing used to be vanishingly rare. For decades, infant botulism was believed to be mostly linked to honey and one-off exposures — not to a product sold in cans on store shelves. Two outbreaks in seven months, both involving whole milk powder, tells me the risk is either growing or has been going undetected all along. Neither answer is comforting.

Why milk powder, and why heat won’t fix it

The key thing to understand is that the bacteria behind botulism form spores — think of them as armored survival pods. Spores are built to withstand drying, time, and heat. And that is where the trouble starts.

Pasteurization kills ordinary bacteria, but it does not kill these spores. Neither does the spray-drying used to turn milk into powder. To reliably destroy botulism spores, you need the kind of intense, pressurized heat used in canning — heat that would scorch milk powder and strip out its nutrients. There is simply no way to apply it to powder without ruining the product. On top of that, fat appears to shield spores from heat even better, which may be one reason whole milk powder keeps showing up rather than nonfat. Bottom line: heat cannot be the safety net here.

Why not just sterilize the formula?

The answer is that we already do sterilize one kind — just not powder.

Ready-to-feed liquid formula is sterile. It is sealed and heat-treated by the manufacturer at temperatures high enough to kill these spores, and FDA says it is the safer choice for higher-risk infants. That is why hospitals reach for liquid in the NICU. Powder is different. You cannot apply that same sterilizing heat to powder without destroying its nutrition and taste, and drying actually makes spores even harder to kill. FDA has said it plainly: powdered formula is not a sterile product.

The catch is cost and access. Liquid runs two to three times the price of powder and does not store or ship as easily. Banning powder is not a realistic answer — the 2022 formula shortage showed how fragile the supply already is. So, the goal is not to get rid of powder. The goal is to make it safer and to be honest with parents about the risk.

The part that worries me most

Parents are told powdered formula is safe “if prepared properly,” which means mixing it with hot water at about 160°F. That advice is real, and it matters — but it was written to kill other germs, like Cronobacter and Salmonella. It does nothing to botulism spores. The spores survive that temperature easily.

Read that again. Parents were told that if they prepared the formula correctly, it was safe. But preparing it correctly gives no protection against the very spores that sickened these babies. The only genuinely protected option on the shelf is ready-to-feed sterile liquid.

What can actually be done

If heat can’t be the safety net, then prevention has to come from several directions at once:

  • Cleaner milk at the source. These spores come from soil and the farm environment, and good udder hygiene at milking measurably reduces them. Formula makers can audit their dairy suppliers and test the milk coming in.
  • Filtering before drying. Heat can’t kill the spores, but physical methods — the same ones cheesemakers use — can strip many of the spores out before the milk is dried into powder.
  • Real testing, including DNA testing. Right now, no rule requires testing infant formula for botulism. DNA testing of ingredients and finished powder is the one tool that found the contamination in ByHeart — and that, used routinely, could catch this kind of problem before a single baby gets sick.

And here is something I have been saying loudly for a while. The very testing that would catch these outbreaks is the testing some defense lawyers quietly tell companies not to do — because if you find a problem, it becomes evidence. In other words: don’t look. I understand the logic, and I reject it completely. A company that chooses not to test so it can claim ignorance is choosing to keep selling a product it has decided not to check. Not looking is not a defense. It is the problem.

The good news: international food-safety regulators have finally started a formal review of botulism risk in powdered formula, and FDA is now testing powdered milk on its own. That is overdue — but it only matters if industry follows through and regulators enforce it. Of note, the U.S. has been stepping away from international health organizations – to its peril I would add – but I will leave that to another blog post.

The bottom line

Botulism spores are everywhere in the environment. They reach milk through the farm, survive pasteurization and drying, and can grow and produce toxin once formula is mixed up in a bottle. Powder cannot be sterilized without ruining it, and the safety advice parents are given was never designed to stop these spores. Heat is not the answer.

What is the answer is cleaner milk, better filtering, honest testing — including DNA testing — and straight talk with parents about why ready-to-feed sterile formula is the safer choice for the most vulnerable babies.

For the families I represent, and for me, the point is simple. In ByHeart, the contamination was in the powder the whole time, and the testing that would have caught it before babies were hurt was not being done. After two outbreaks in seven months, routine testing of dairy ingredients and finished powder — including DNA testing — is no longer optional. 

These outbreaks were preventable. And if industry won’t fix it, the courts and the regulators will.

Sources

  1. FDA, Outbreak Investigation of Infant Botulism: Infant Formula (November 2025) — ByHeart.  https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-infant-botulism-infant-formula-november-2025
  2. FDA, Post-Outbreak Response Activities: Clostridium botulinum Illnesses Associated with Consumption of Powdered Infant Formula — final ByHeart summary (48 infants, 17 states; outbreak declared over February 26, 2026).  https://www.fda.gov/food/outbreaks-foodborne-illness/post-outbreak-response-activities-clostridium-botulinum-illnesses-associated-consumption-powdered
  3. FDA, Outbreak Investigation of Infant Botulism: Powdered Infant Formula (June 2026) — Nara Organics.  https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-infant-botulism-powdered-infant-formula-june-2026
  4. CDC, Investigation Update: Infant Botulism Outbreak Linked to Infant Formula, November 2025.  https://www.cdc.gov/botulism/outbreaks-investigations/infant-formula-nov-2025/investigation.html
  5. CDC Newsroom, Outbreak Update: Infant Botulism Linked to Powdered Infant Formula (June 13, 2026).  https://www.cdc.gov/media/releases/2026/infant-botulism-outbreak-linked-to-powdered-infant-formula-june-2026.html
  6. FDA, Handling Infant Formula Safely: What You Need to Know; and FDA/WHO guidance on reconstituting powdered formula with water at about 160°F (70°C), a step aimed at Cronobacter and Salmonella — not botulism spores.
  7. Health Canada, Preparing and Handling Powdered Infant Formula — recommends commercially sterile liquid formula for premature, low-birth-weight, or immunocompromised infants.
  8. Molin, N. & Snygg, B.G. (1967). Effect of Lipid Materials on Heat Resistance of Bacterial Spores. Applied Microbiology, 15(6):1422–1426 — spores survive heat better in fat than in buffer.
  9. Burtscher, J., Rudavsky, T., Zitz, U., Neubauer, V. & Domig, K.J. (2023). Importance of Pre-Milking Udder Hygiene to Reduce Transfer of Clostridial Spores from Teat Skin to Raw Milk. Microorganisms, 11(5):1337.
  10. Codex Committee on Food Hygiene / Joint FAO–WHO Expert Meeting on Microbiological Risk Assessment (JEMRA): review of spore-forming pathogens, including C. botulinum, in powdered infant formula (2025–2026).

Whole Milk Again!

Nara Organics Powdered Infant Formula was distributed nationally across Target retail stores, Target.com, and Nara.com between July 2025 and June 2026. Nara Infant Formula is not distributed outside of the USA.

The FDA and CDC, in collaboration with the California Department of Public Health (CDPH), Infant Botulism Treatment and Prevention Program (IBTPP), and state and local partners, are investigating a multistate outbreak of three confirmed or suspected infant botulism illnesses from three states: California, Pennsylvania, and Washington. The CDPH IBTPP reported three toxin type A infections among infants consuming Nara Organics Whole Milk Organic Powdered Infant Formula with illness onset between April and May 2026. All three cases included in this outbreak consumed Nara Organics-brand powdered infant formula. Officials in two states have collected leftover infant formula for testing. This testing is underway, and results are expected in the coming weeks. 

FDA contacted the firm and recommended that the firm conduct a recall due to the severity of illnesses and the epidemiological signal. On June 13, 2026, Nara Organics agreed to recall all of their Nara Organics brand Whole Milk Organic Powdered Infant Formula. All of Nara Organics’ formula was manufactured in Europe. Consumers should not use recalled infant formula. 

FDA’s investigation is ongoing. This advisory will be updated as information becomes available. For more information about FDA’s ongoing efforts to ensure the safety of infant formula please see FDA’s Clostridium botulinum Illnesses Associated with Consumption of Powdered Infant Formula webpage.  

Affected Formula

All cans of Nara Organics Infant Formula are being voluntarily recalled. Stop using all Nara formula immediately.  The three specific product lots these infants were exposed to are: 709125280E14F2, 709125288E14F2, 708125174E14F2.

All Recalled Lot Codes

  • 408125075E14F2
  • 708125076E14F2
  • 708125083E14F2
  • 408125139E14F2
  • 708125141E14F2
  • 708125145E14F2
  • 708125174E14F2
  • 709125273E14F2
  • 709125280E14F2
  • 709125288E14F2
  • 409125307E14F2
  • 70926019ENNB
  • 70926029ENNB
  • 70926035ENNB
  • 70926039ENNB
  • 70926042ENNB

A father named Chris George spent the better part of a year trying to answer a question that should not have been hard to answer: that grew and processed the lettuce that nearly killed his son?

Colton George, now ten, was nine years old when he ate romaine contaminated with E. coli O157:H7 in the fall of 2024. He spent eighteen days in the hospital. He developed hemolytic uremic syndrome — the complication I have watched destroy children’s kidneys for more than thirty years — and he came out the other side on nine days of continuous dialysis, five more days of intermittent dialysis, and five blood transfusions. He recovered from the acute phase. He will see a nephrologist for the rest of his life.

While Colton was in that hospital bed, the FDA already knew the names of the companies that grew and processed the lettuce. It had the names in its files. It posted a case count and a likely source on its outbreak table on December 4, 2024. And it left the one fact that mattered to Colton’s family — the names — blacked out, because there was no active recall and the agency had decided that a company’s names were “confidential commercial information.”

I have been making the same argument for years, and I am going to make it again, because the FDA keeps forcing me to: a company’s name is not a trade secret, and it is not confidential commercial information. Stop Foodborne Illness has now put that argument in front of the agency in a formal citizen petition, and the petition is right. The FDA should grant it.

Let me be clear at the outset about what I am — and am not — asking for. I am not asking the FDA to name a company on a hunch, a rumor, or a single unconfirmed complaint, and I am certainly not asking it to disclose a name where the evidence does not establish that company or product as a source of the outbreak. I am asking for disclosure when the agency’s own investigation — the epidemiology, the traceback, and the laboratory evidence — points to a particular company or product as a source. When the evidence is there, the name belongs to the public. When it is not, no one is asking the agency to guess.

The line is not hard to draw

The agency hides behind the Trade Secrets Act and FOIA Exemption 4, and it treats the name of a food company linked to an outbreak as if it were a proprietary formula. It is not. Read the statute. Section 1905 protects trade secrets, processes, operations, style of work, and the financial guts of a business — income, profits, losses, sources of revenue. It says nothing about a company’s name, because a name is none of those things.

The courts have already drawn the line the FDA refuses to draw. In CREW v. Department of Justice, the D.C. Circuit held that a company’s name is not “commercial or financial” information in and of itself, and that the possibility of reputational or economic fallout from being named is not enough to make it so. And under the Supreme Court’s Argus Leaderdecision, information only qualifies as “confidential” if it is customarily kept private and shared under some assurance of secrecy. Neither is true here. A company that grows, processes, and sells food to the public operates in the open. It puts its name on the package. It advertises on that name. It builds a brand on that name. You cannot market a product to millions of people under your name on Monday and then call that same name a confidential secret on Tuesday when the product turns out to be contaminated.

This is the distinction I have drawn my entire career, and it has never been complicated. Formulations, ingredients, and how a product is made are trade secrets and deserve protection. Who supplied the tainted raw material, who made the tainted product, and where it was sold are not — especially during an outbreak. The agency simply refuses to draw that line, and it dresses up a public-health record as proprietary business information to avoid drawing it.

We have already run the experiment

We do not have to guess whether naming companies would cause the sky to fall. We ran the experiment two decades ago. For most of the 2000s, the USDA’s Food Safety and Inspection Service would name the manufacturer of E. coli-contaminated meat but refused to say where it was sold. I still remember people sickened in the 2002 ConAgra outbreak telling investigators they had heard about the recall but figured it did not apply to them because they bought their hamburger at Safeway, not at ConAgra. FSIS eventually started naming retailers. Chicken Little was wrong. The sky did not fall. What changed was that people could finally figure out whether the dangerous product was in their own refrigerator.

That is the part of this that the FDA keeps missing. Withholding the name does not protect anyone but the company. The agency’s current policy actually leaves consumers of fresh produce in the dark more often than consumers of processed food — because produce spoils, recalls happen less often, and so the trigger that unlocks disclosure never gets pulled. We tell Americans to eat more fruits and vegetables. This administration has built an entire health initiative around “whole, healthy” food and radical transparency. And then, when leafy greens sicken and kill people, the agency refuses to tell those same Americans which brand did it. That is not transparency. That is the opposite.

A name, when the evidence supports it — not before

I said at the top that I am not asking the agency to guess, and it is worth pausing on why, because this is where industry will try to muddy the water. The standard I am describing is not a loose one. It does not mean publishing a list of every farm, processor, or brand that happened to be somewhere in the supply chain, and it does not mean naming a company on a single complaint or an early hunch. It means disclosure once the agency’s investigation has done its work — when the epidemiology, the traceback, and the laboratory evidence point to a particular company or product as a source.

What I am asking for is the opposite of guessing. That is the standard the FDA already applies to itself every day. It is the same evidence the agency relies on to post an outbreak, to issue a warning, to support a recall. If the evidence is strong enough for the FDA to act on it, it is strong enough to share with the families whose lives that evidence is about. The objection is never that the FDA might name the wrong company. The objection is that it would have to name the right one.

Stop Foodborne Illness is asking for exactly that.

What the FDA should do

The petition lays out a clean path, and the agency can take it tomorrow without waiting years for a rulemaking:

First, stop calling a company’s name confidential commercial information. The simplest fix is also the most honest one. The FDA can issue a statement or memorandum announcing that it no longer reads the Trade Secrets Act to cover the name of a company linked to an outbreak. The statute does not require the agency’s current interpretation, and the case law cuts against it.

Second, if the agency insists on keeping the CCI label, it can still release the name under its own public-health authority. The FDCA directs the FDA to ensure that food is safe, wholesome, and properly labeled. That is “provided by law” disclosure, full stop. The agency has already done exactly this — in the 2022 “Power Greens” outbreak it named the brands involved even though there was no recall and the product was past its expiration date. It can do that every time. It should.

Third, and least preferred, the agency can rewrite 21 C.F.R. §20.91 to allow disclosure of a brand name whenever it is known, not only when a recall is underway. This works, but it takes years, and families do not have years.

There is no public-health argument for secrecy here, only a public-relations one — and not even the company’s, but the agency’s. Naming a company linked to an outbreak prompts people who got sick but never connected the dots to seek care and report. It tells people who still have the product at home to throw it out. And it does the one thing that actually makes food safer over time: it gives a company a powerful reason not to be named again.

Chris George should not have had to hire me to spend a year chasing a name the government already had. The next parent should not have to either. Grant the petition.

Here is the full Petition:

https://www.marlerblog.com/files/2026/06/STOP-CCI-Petition-Final-2.4.2026.pdf

On Thursday, June 11, 2026, the FDA quietly posted to its website the document those of us investigating the ByHeart infant-botulism outbreak have waited months to see: the complete Establishment Inspection Report (EIR) for Blendhouse Allerton, LLC — the Iowa plant that produced ByHeart’s infant-formula base powder.

Credit where it is due: Bloomberg’s Anna Edney was first to flag the release, reporting that federal inspectors found no evidence ByHeart’s own production “caused” the outbreak and pointed instead toward contaminated ingredients. You can read her piece here: FDA Finds No Evidence ByHeart Production Caused Infant Formula Botulism Cases. She is right — but a 55-page government report holds far more than any headline can, so I read all of it.

So can you. Here is the actual source document: FDA Establishment Inspection Report, Blendhouse Allerton, LLC (FEI 1921383), inspection 11/11/2025–01/22/2026 — https://www.fda.gov/media/192916/download.

This full EIR is a different and much longer document than the three-page Form FDA 483 that issued back in January. The 483 is simply Attachment 1 to this report. The narrative, the findings, and FDA’s conclusions live in the EIR — and the EIR is what went public Thursday.

What the FDA actually concluded:

After weeks on site, FDA’s investigators wrote, on page 35, that the genetic match between the Clostridium botulinum–positive ingredients and both a sick infant and a previously manufactured finished product “appears to indicate that raw materials were more likely the source of the outbreak than the firm’s processing equipment and storage practices.”

In plain English: the spores most likely rode in on an ingredient.

That ingredient is organic whole milk powder. The report lays out how, on January 21, 2026, ByHeart’s VP of Quality told FDA that lots of organic whole milk powder had tested presumptive-positive for C. botulinum, and that one isolate matched both a clinical sample from a sick baby and a ByHeart finished product (pp. 31–32). The CORE team identified organic whole milk powder as “an ingredient of concern” (p. 34). FDA collected a dozen base-powder samples tied to the recalled finished lots — 251131P2, 251261P2, 251481P2, and 243201P2 — and shipped them out for botulinum testing (pp. 47–48).

Follow the milk: Organic West Milk → Dairy Farmers of America → Organic West Milk → ByHeart

The EIR redacts the supplier names, but the supply chain is no longer a secret. As the Associated Press’s Jonel Aleccia first reported, the organic whole milk powder was made from fluid organic whole milk supplied by Organic West Milk, Inc., a California company that pools milk from 55 farms, and was dried into powder at a Dairy Farmers of America (DFA) plant in Fallon, Nevada. DFA dried the milk for Organic West Milk, Inc., that sold the powder to ByHeart, and the lot FDA collected at the DFA plant genetically matched the outbreak strain.

So, the chain runs like this:

  • Fluid whole milk — Organic West Milk, Inc. (California, 55 farms)
  • Powdered whole milk — Dairy Farmers of America, Fallon, Nevada (dries the milk)
  • Infant-formula base powder — ByHeart at Blendhouse Allerton, Iowa
  • Finished, canned formula — ByHeart’s Blendhouse Portland, Oregon plant
  • The Retailers — the stores that sold the can to a parent

The agency was looking hard upstream: FDA’s investigators collected “Audit Observations at DFA” as Exhibit 81 (p. 51), alongside ingredient tracebacks. 

And the finger-pointing has predictably begun — ByHeart points upstream, DFA has emphasized that the maker of the end product bears responsibility to properly process ingredients for safety, while Organic West’s owner has suggested something went wrong in turning milk into powder and powder into formula. Everyone in the chain is pointing at the next link.

What “the ingredients did it” does not mean:

Here is where I want to be very clear, because the spin will be loud: identifying a contaminated milk ingredient does not get ByHeart off the hook. Not legally, and not morally.

Blendhouse Allerton is the sole producer of the base powder used in ByHeart’s formula (p. 1). And the very same report that points upstream also handed ByHeart a fresh three-item Form 483 (pp. 41–44):

  • A process-intrusion flush that was never documented after black rubber pieces were found in the line, with no rationale recorded — 21 CFR 106.50(a)(1);
  • A finding that the firm did not ensure all ingredient-contact surfaces were cleaned and sanitized — specifically, an oil storage silo that did not receive the second caustic wash its own procedure required — 21 CFR 106.30(b); and
  • A base mix that dropped below its required temperature and was fed forward with no management approval, where the firm failed to evaluate the public-health significance of the deviation — 21 CFR 106.6(c)(4).

Worse, two observations from the February 2025 inspection were carried into this report as still “Not Corrected”: failing to maintain the building in a clean and sanitary condition (21 CFR 106.20(a)) and approving and releasing an ingredient that was not held under conditions to prevent adulteration (21 CFR 106.40(f)(3)) (pp. 2–3). Read that last one again. Months before babies got sick, FDA had already cited this plant for releasing an ingredient that wasn’t held under conditions to prevent adulteration — and at the time of this outbreak report, it still wasn’t fixed. And look at what that February 2025 inspection actually found. Its very first observation named the exact ingredient now at the center of this outbreak: FDA cited the plant for receiving and releasing whole organic dried milk powder that was not held under conditions to prevent adulteration (p. 1). The same inspection faulted the firm for failing to eliminate rodent-harborage areas after rodent problems in 2024–2025, and for not adequately monitoring the dryer floor after findings of confirmed Cronobacter sakazakii — a pathogen that can be deadly to infants and that drove the massive 2022 Abbott formula recall (pp. 1–2). This plant was already on notice about the milk, about the rodents, and about a baby-killing organism at its dryer, months before a single child got sick.

And then the central point: Clostridium botulinum spores in dairy are a known, foreseeable hazard. The entire job of an infant-formula manufacturer is to control the hazards in the ingredients it buys — because the end product goes into the most vulnerable humans on earth, whose immature guts allow those spores to germinate and produce toxin. ByHeart’s own June 10 “action plan” now promises C. botulinum-specific testing of every dairy ingredient and every finished batch before release. That is a tacit admission that this hazard was testable and controllable all along. You do not get credit for installing the smoke detector after the house has burned down. Nor was the hazard hypothetical at this plant. In January 2025, BHA’s own records (SNC25-002-BHA) document pallets of organic whole milk powder arriving with visible gnaw holes, spilled powder, and potential rodent droppings (p. 15) — rodent contamination on the very ingredient that carries C. botulinum spores. FDA ultimately concluded those particular contaminated pallets were not the source of this outbreak — they involved different lots received at a different warehouse (p. 35) — but that misses the larger point. A plant that has already watched gnawed, soiled bags of milk powder come through its doors knows exactly how filth rides in on this ingredient, and exactly why every lot of it must be controlled before it ever reaches a baby.

The bottom line:

Forty-eight infants were hospitalized across seventeen states. None died — but botulism can leave lasting harm, and these are babies. The FDA report does real and important work tracing the spores to a milk-powder ingredient and to the companies that supplied and processed it. Organic West Milk and Dairy Farmers of America will have to answer for the lot that carried the outbreak strain, and they should. The scale of the danger is in the report itself: the recall began with two lots on November 8, 2025, grew to every lot of ByHeart formula by November 19, and FDA classified it Class I — the agency’s most serious category, reserved for products that can cause serious injury or death. It was still ongoing when inspectors closed this report (pp. 8–9).

But a company that puts its name on a can of infant formula — that markets it as the closest thing to breast milk — cannot outsource responsibility for what is inside that can. ByHeart chose its suppliers, bought the ingredient, made the base powder, and sold the product to parents who trusted it. Pointing at the milk explains how the spores got in. It does not change who was responsible for keeping them out. The buck — and the baby’s bottle — stopped with ByHeart.

And the responsibility does not stop at ByHeart. Every company that sold this formula to a family is part of the chain of distribution of an adulterated, dangerous product — and under long-settled product-liability law, sellers in that chain can be held strictly liable for placing it into a parent’s hands, whether or not they knew what was in the can. The grocery chains, pharmacies, big-box stores, and online sellers that stocked and shipped recalled ByHeart formula profited from moving this product to the most vulnerable consumers there are. That carries a legal duty, and it carries a moral one. When a retailer chooses to sell infant formula, it vouches for that product to every parent who trusts its shelves — and when the product turns out to be contaminated, it shares in the responsibility to the babies who were harmed.

I have spent more than thirty years representing the families on the wrong end of food that should never have been sold — and this report follows the oldest pattern I know: a contaminated ingredient travels down a chain of companies, and the moment babies are hurt, every one of them points at the next link. 

I am not interested in that game, and neither should you be. Trace this outbreak honestly and it runs in a straight line — from the farms that supplied Organic West Milk, to the Dairy Farmers of America plant in Fallon, Nevada that dried that milk into powder, to ByHeart and its Blendhouse plant in Iowa that turned the powder into base, to the Portland plant that sealed it into a can, to the grocery shelves and online carts that put it within a parent’s reach. 

FDA warned this entire industry, by name, in March 2023 that Clostridium botulinum was a known hazard in powdered infant formula — and that an ingredient supplier whose milk receives no lethal treatment is, in the agency’s words, “an extension of the infant formula manufacturing process.” 

Every company in that line had a duty to the child at the end of it, and the law of strict products liability holds every one of them to it. Forty-eight babies in seventeen states had no say in which of these companies cut which corner. They are owed answers, they are owed accountability, and they are owed the one thing this chain was built to deliver and did not: a can of formula that was safe to feed a baby. From the milk to the shelf, that was everyone’s job — and these babies are everyone’s responsibility.

Why the food industry should embrace whole genome sequencing (WGS) — even when it’s inconvenient

I few weeks ago I was supposed to give a talk about the pros and cons of WGS and the food industry.  I never made it to the talk because my day job got in the way.

When I started suing food companies more than thirty years ago, after E. coli O157:H7 in undercooked Jack in the Box hamburgers killed four children and sickened hundreds, proving where a pathogen came from was slow, painstaking, and often impossible. Investigators matched bacteria using crude “fingerprinting” methods that could tell you two samples looked similar, but rarely that they were truly the same organism.

That world is gone. Whole genome sequencing — reading the complete DNA of a bacterium — has done for foodborne illness what DNA testing did for criminal forensics. Today, when Listeria turns up in a nursing-home resident in California and in a frozen nutritional shake produced two thousand miles away, public-health scientists can say with near-certainty it is the same organism. The FDA’s GenomeTrakr and the CDC’s PulseNet databases and NCBI’s website now hold hundreds of thousands of these genomic fingerprints. The 2025 Lyons Magnus outbreak — 42 sickened, 14 dead across 21 states — was solved this way. So was the largest and deadliest listeriosis outbreak in history: the 2017–2018 South African catastrophe that killed 216 people and was traced, through a single sequence type called ST6, back to polony from one Tiger Brands plant in Polokwane.

For public health, the case is overwhelming. WGS finds the source faster, thereby making outbreaks smaller, narrows recalls so they strike the guilty product instead of an entire commodity, and catches contamination at vanishingly low levels. None of that is seriously in dispute.

The harder question — and the one companies actually ask me — is whether a food producer should run that same technology on its own products and inside its own plant.

Here is the uncomfortable part, and I’ll say it plainly because the industry’s lawyers usually won’t: a positive result you generate today can be used against you tomorrow. If you swab your plant and find Listeria in a floor drain, sequence it, and that genome later matches a sick child’s, you are tied to that case in a way no jury will forget. Some defense attorneys take the logical next step and quietly advise their clients to test less — because what you don’t know can’t be subpoenaed.

I have spent decades on the other side of that advice, and I am here to tell you the bad advice is both morally bankrupt and, in the long run, a legal disaster.

Choosing not to look is not a defense. It is willful blindness, and juries understand it instantly. The company that finds a resident strain, documents it, and surgically eliminates it has a contemporaneous record of doing exactly what a responsible food producer is supposed to do. The company that decided ignorance was safer has a record of nothing — until the outbreak arrives anyway, larger and deadlier for having gone undetected, and a plaintiff’s lawyer like me asks under oath why a company with hundreds of millions in revenue chose not to use a technology that a public-health lab in a developing nation could afford.

And WGS cuts both ways. The same precision that can implicate you can clear you. When your product is swept into an outbreak it had nothing to do with, your genomic data is the fastest route to proving your strain is not the strain — to getting your name out of the headline and your trucks back on the road. I have watched sequencing exonerate an accused producer as decisively as it has condemned a guilty one.

WGS is not magic. It demands real bioinformatics expertise, validated pipelines, and reference databases that still have gaps for rare and emerging pathogens.

But none of that is an argument for staying in the dark. The food industry’s reflex has been to know as little as possible about its own contamination, on the theory that what it didn’t know couldn’t hurt it in court. The genome has ended that bargain. The pathogens in your plant already have a fingerprint. The only question is whether you are willing to read it before someone’s child does.

  • A new outbreak of Salmonella Enteritidis (ref #1378) linked to a not yet identified product has been added to the table. FDA has initiated traceback. 
  • For the outbreak of Listeria monocytogenes (ref #1380) linked to requeson/soft ricotta cheese, FDA has initiated sampling. On June 9, 2026, FDA updated the outbreak advisory to include a downstream recall and provide sampling updates. 
  • For the outbreak of Cyclospora (ref #1375) linked to a not yet identified product, the case count has increased from 7 to 8.
  • For the outbreak of Salmonella Typhimurium and Newport (ref #1358) linked to moringa leaf powder, FDA updated the outbreak advisory on June 3, 2026 with additional recalled products.

New York, Virginia, Maryland each have three illnesses, with one death in Maryland.

As of June 9, 2026, a total of 9 people infected with the outbreak strain of Listeria have been reported from 3 states. Sick people’s samples were collected on dates ranging from March 6, 2023, to May 10, 2026. Of 9 people with information available, 8 have been hospitalized and 1 death has been reported from Maryland.

Epidemiologic, laboratory, and traceback data show that some requesón cheeses supplied by Clover Hill Dairy are contaminated with Listeria monocytogenes and are making people sick. The investigation is ongoing to determine the source of contamination and whether additional cheeses are linked to the outbreak.

New York State Department of Agriculture and Markets (NYS AGM) collected samples at a retail location shopped at by sick people. One sample of requesón that was repackaged at this retailer tested positive for Listeria monocytogenes. WGS confirmed the Listeria in the repackaged cheese is the same as the Listeria making people sick in this outbreak.

NYS AGM also went to the distributor who supplied cheese to the retail location. They collected a sample from an unopened 18-pound bucket of requesón that was supplied by Clover Hill Dairy. This sample tested positive for Listeria monocytogenes. Whole genome sequencing showed the strain from the cheese is the same strain as the sick people.

Recalled products were distributed in North Carolina, New York, Virginia, Maryland, New Jersey and Washington, DC.

This outbreak may not be limited to the states with known illnesses, and the true number of sick people is likely higher than the number reported. This is because some people recover without medical care and are not tested for Listeria.

Listeria:  Marler Clark, The Food Safety Law Firm, is the nation’s leading law firm representing victims of Listeria outbreaks. The Listeria lawyers of Marler Clark have represented thousands of victims of Listeria and other foodborne illness outbreaks and have recovered over $900 million for clients.  Marler Clark is the only law firm in the nation with a practice focused exclusively on foodborne illness litigation.  Our Listeria lawyers have litigated Listeria cases stemming from outbreaks traced to a variety of foods, such as lettuce, polony, deli meat, cantaloupe, cheese, celery and milk.   

If you or a family member became ill with a Listeria infection after consuming food and you’re interested in pursuing a legal claim, contact the Marler Clark Listeria attorneys for a free case evaluation.

Additional Resources: