Infant botulism from powdered formula was not a freak accident. It was foreseeable — and the people who could have prevented it chose to wait for sick babies instead.

For over thirty years I have heard the same line from every defendant: nobody could have seen this coming.

Over the past year, two powdered infant formulas gave babies botulism. By CDC’s accounting, ByHeart’s Whole Nutrition formula sickened 48 infants across 17 states. Months later, Nara Organics’ Whole Milk Organic formula sickened three more in California, Pennsylvania, and Washington. These are not statistics. They are babies who went limp, stopped sucking, stopped breathing, and spent weeks in hospitals on a drug called BabyBIG — an antitoxin made from human plasma — because spores of Clostridium botulinum germinated in guts too young to fight them off.

The hazard was known. The pathway was known. The fix was available. And the government’s own record proves it.

Start with the international authorities. In 2004, a joint FAO/WHO expert meeting sorted the microbes that can ride along in powdered infant formula by how strong the evidence was that each one made babies sick. They put Clostridium botulinum in the bottom category: “causality less plausible or not yet demonstrated.” Read that again. The world’s food-safety experts found botulism in the product and filed it under not yet.

Not yet is not, not, a risk.

The same report admitted the uncomfortable truth at the center of this whole business: powdered infant formula “is not a sterile product and may occasionally contain pathogens.” Codex followed in 2008 and declined to treat botulism as a hazard in infant formula at all. The international microbiology body followed in 2014 and recommended that manufacturers not even bother routinely testing for it.

Meanwhile, the science on where these spores come from was sitting in plain sight. A 2010 peer-reviewed review laid out the entire chain: C. botulinum lives in soil and silage, cattle pick it up, the spores pass into raw milk, and — this is the part that matters — ordinary pasteurization does not kill them. Dry that milk into powder, and the spores are concentrated and come along for the ride into the can.

The dairy industry knew it, too. For years it ran funded “low-spore milk powder” programs, set numerical spore tolerances, and taught processors to keep spores out starting at the farm gate. They built the entire playbook — for taste and shelf life. They simply never ran it for the one spore that paralyzes infants.

And then there is the warning that should have ended this argument before it started. On March 8, 2023 — two years before the first ByHeart baby got sick — the FDA sent a Call-to-Action letter to every manufacturer, packer, distributor, importer, and retailer of powdered infant formula in the country, signed by the Commissioner of Food and Drugs and the Director of the agency’s food-safety center. It did not bury the issue; it named the organism. The agency wrote that “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 United States government told this industry, in writing and by genus and species, to control for botulism. Then it watched the industry not do it.

The agency even said it would do more. In March 2025, under its “Operation Stork Speed” initiative, the FDA announced it would increase testing of infant formula and its ingredients for spore-forming contaminants — naming Clostridium botulinum and Bacillus cereus specifically. That announcement came months before the ByHeart outbreak was announced. But announcing that the government will test is not the same as requiring that the hazard be controlled before a single can reaches a shelf.

Everyone with a seat at the table knew the spores were in the milk. They knew the milk wasn’t sterilized. They knew the powder wasn’t sterile. And they decided that because no one had yet proven a baby was poisoned this way, there was nothing to control.

Then ByHeart happened and watch how fast the story changed.

FDA started testing milk powder, nonfat dry milk, and whey for botulism — and its own deputy commissioner for human foods said publicly that the testing would help determine whether this is a “foreseeable hazard that companies could test for.” I had to put the paper down. Yes. It is. It was. 

Codex agreed — in December 2025, and only because of ByHeart, the international food-hygiene committee finally opened work on controlling C. botulinum in infant formula. ByHeart, for its part, now promises to test every dairy ingredient and every finished batch for botulism before release.

I will say what I said when the inspection report came out: you do not get credit for installing the smoke detector after the house has burned down.

There is something else worth saying out loud. Both the ByHeart and Nara outbreaks were organic whole milkformulas, and in the ByHeart case FDA genetically matched the botulism in the formula to the organic whole milk powder that went into it. I am not going to stand here and tell you whole milk is the villain. The honest point is narrower, and worse: the safety standards never bothered to ask whether premium, pasture-sourced, whole-milk powder might carry a different spore load than the commodity powder their comfortable assumptions were built on. They assumed low risk across the board, and never checked.

This is the real failure: a regulatory system that treated the absence of proven dead babies as proof of safety. “Causality not yet demonstrated” is a confession dressed up as a finding. It means we are going to keep selling this until a sick baby proves us wrong. Forty-eight babies, and then three more, proved them wrong.

So do better. Specifically:

  • Make it mandatory. FDA and Codex should require botulism and clostridial-spore controls and testing for the dairy ingredients that go into infant formula — not “voluntary,” not “consider,” but required, including the sulphite-reducing-clostridia process indicators the experts themselves identified more than a decade ago.
  • Finish the work now. Codex opened the file in December. Do not let it die in five years of meetings. Babies do not run on a committee calendar.
  • Treat the powder like what it is. Powdered formula is not sterile. Stop letting anyone — regulator or marketer — imply that it is. A parent mixing a bottle for a newborn deserves the truth on the label.
  • Open the records. No parent should have to file a FOIA request, and fight through redactions, to learn what a company told the government about the milk in their baby’s bottle. The submissions, the hazard analyses, the inspection findings — put them in the sunlight.

Every one of these cases is a preventable failure that happened before a single baby got sick. The spores were always in the milk. The only question was whether anyone with the power to act would look before, or only after.

They looked after. Again.

Do better.

  • A new outbreak of Clostridium botulinum (ref #1383) linked to a Nara Organics Whole Milk Powdered Infant Formula has been added to the table. On June 13, 2026, Nara Organics announced a recall and FDA issued an advisory. FDA has initiated traceback. 
  •  A new outbreak of Cyclospora (ref #1381) linked to a not yet identified product has been added to the table. FDA has initiated traceback. 
  • For the outbreak of Salmonella Enteritidis (ref #1378) linked to a not yet identified product, the case count has increased from 62 to 68.
  • For the outbreak of Listeria monocytogenes (ref #1380) linked to requeson/soft ricotta cheese, FDA updated the outbreak advisory on June 12 and 15, 2026, to include retail sites of some recalled product, an expanded recall for all Clover Hill Dairy cheese products, and sampling updates.
  • For the outbreak of Cyclospora (ref #1375) linked to a not yet identified product, the outbreak has ended. 
  • For the outbreak of Salmonella Typhimurium and Newport (ref #1358) linked to moringa leaf powder, FDA updated the outbreak advisory on June 12, 2026, with additionally recalled lots. 

The phrase “Never let a serious crisis go to waste” is usually attributed to Rahm Emanuel and usually said with a wink — a crisis grabs the public’s attention and opens room for things that, in calmer times, never make it out of committee. I am going to say it without the wink.

For more than thirty years — since the 1993 Jack in the Box E. coli outbreak — I have represented families poisoned by food they trusted and told anyone who would listen that my goal is to put myself out of business by making food safe. The cruel arithmetic of my work is that reform rarely arrives until enough people are hurt to force it. We have done exactly this before: the Jack in the Box outbreak is what pushed USDA’s Food Safety and Inspection Service to declare E. coliO157:H7 an adulterant in ground beef in 1994 — a single decision that made hamburger dramatically safer and has kept countless children out of hospital beds in the decades since. That was a crisis put to use, not wasted. We have a window open like that right now, and when Congresswoman Rosa DeLauro introduced the bipartisan Infant Formula Safety Modernization Act of 2026, I read every line. It is sober, specific, and it closes the exact gaps that let babies get hurt — on my watch and on the government’s. I support it without reservation, and the outbreaks are the argument.

We knew about Cronobacter for twenty years. In 2001, a Cronobacter (then called Enterobacter sakazakii) outbreak in a Tennessee NICU killed a newborn, traced to a contaminated lot of powdered formula; in April 2002 FDA warned hospitals against using powdered formula in NICUs because it is not sterile. And still, in 2022, four infants were infected with Cronobacter sakazakii from formula made at Abbott’s Sturgis, Michigan plant, and two died. The plant — roughly forty percent of the domestic supply — shut down, triggering a months-long national shortage. The lesson we failed to learn: our formula supply is dangerously concentrated, and our testing regime was built only for the pathogens we already knew about.

Then botulism — twice. The ByHeart outbreak of November 2025 was the first documented outbreak of botulism in the United States ever attributed to contaminated infant formula: at least 48 infants across 17 states, every one hospitalized. I represent some of those families. FDA’s whole-genome sequencing traced the C. botulinum to a routine ingredient — organic whole milk powder, sampled at Dairy Farmers of America, the processor for ByHeart’s supplier — and one ByHeart-affiliated Blendhouse facility in Reading, Pennsylvania had already been flagged “Official Action Indicated,” FDA’s most serious inspection finding, years earlier.

Seven months later, it happened again. Three more infants — in California, Pennsylvania, and Washington, all two to five months old, all hospitalized and treated with BabyBIG, all fed Nara Organics Whole Milk Organic Infant Formula bought at Target. The detail that stitches this together: Nara’s formula is manufactured in Europe. To be fair about the science, no Nara lot has yet tested positive for C. botulinum and confirmatory testing is still pending — but that cuts both ways: detection is notoriously hard, a negative does not clear a product, and three infants do not land in the hospital on the same brand by coincidence. A second botulism outbreak in the same year was not a freak event. It was foreseeable — we had just lived through the first — and the system did nothing in between.

And this is neither new nor only ours. In Europe this past winter, a multi-country recall of infant nutrition followed the detection of cereulide — a toxin produced by Bacillus cereus in arachidonic acid oil from a single Chinese supplier; the European Food Safety Authority was left scrambling to set a basic infant safety threshold after the recalls began, while Nestlé and Danone faced scrutiny over “silent” withdrawals made before any public recall. Go back to 2013, when New Zealand’s Fonterra warned that batches of whey protein concentrate — a powdered formula ingredient — might carry Clostridium botulinum, triggering a global infant-formula recall before testing identified the harmless cousin Clostridium sporogenes. A false alarm, yes — but more than a decade ago a botulism threat in powdered formula was plausible enough to clear shelves worldwide, so no one got to act surprised when the real thing surfaced in 2025.

The record runs deeper still. In 2017, Salmonella Agona in infant formula made at the Lactalis plant in Craon, Francesickened dozens of babies and forced a recall of more than 7,000 tons across some eighty countries — the same strain that had contaminated the same plant in 2005, with Lactalis accused of knowing months early, botching the recall, and later criminally charged with “aggravated deceit.” And in 2008, melamine added to watered-down milk in China sickened an estimated 300,000 infants and young children and killed at least six, after the producer sat on complaints for the better part of a year. A plant that poisons babies twice with the same bug; a company that knows and waits; testing you can game. Sound familiar?

These are not isolated tragedies. Cronobacter since 2001, melamine in 2008, a botulism scare in 2013, Salmonella in 2017, botulinum twice in 2025 and 2026, cereulide across Europe this winter. The thread is not bad luck. It is a system that tests for too little, too late, and tells too few people when something goes wrong.

DeLauro’s bill amends the Federal Food, Drug, and Cosmetic Act and does six concrete things, each mapped to a failure above.

Expand required pathogen testing. Current law effectively requires testing finished formula only for Cronobacter and Salmonella. Clostridium botulinum was not on the list — which is precisely why two botulism outbreaks slipped through. The bill directs FDA to build a real list and names C. botulinum on it.

Mandate environmental testing inside the plant. Standardized monitoring of Zones 2 and 3 catches contamination in the production environment before it reaches a can on a Target shelf. Standard practice elsewhere; astonishingly, not required by law for the food we feed newborns.

Set consistent standards. FDA sets the testing frequency, so “we tested” means the same thing at every facility instead of each company grading its own work.

Require early FDA notification — within one business day of a positive test, even before product leaves the building. This is the one that haunts me. Today a company can get a positive and sit on it: Lactalis allegedly did for months; recalled ByHeart product lingered on shelves for weeks; Europe saw “silent” withdrawals. Mandatory early notice shrinks the gap between when the company knows and when parents do — and in botulism, that gap is measured in hospitalized babies.

Hold foreign manufacturers to the same standards. This used to read like housekeeping. Not anymore: ByHeart’s botulinum rode in on an imported ingredient, the European cereulide on a Chinese supplier’s oil, and Nara’s formula — behind the second outbreak — is made in Europe. If it is sold to an American baby, it should meet American testing requirements, whether it was made in Iowa or shipped in on a pallet.

Strengthen Congressional oversight. The bill requires notice to Congress of any confirmed positive in finished formula and any “Official Action Indicated” finding. Remember Reading, Pennsylvania: that finding existed and went nowhere. Sunlight is how “we knew” stops being something we learn in a deposition years later.

The bill also gives FDA 90 days to finalize the rules. Good. We have waited long enough.

I make my living, in part, because companies cut corners and regulators are under-resourced. I would rather not. The families I represent never wanted a lawsuit; they wanted a healthy baby and a safe can of formula. Every provision here is something that, had it been law a year ago, might have meant fewer of those families ever needing to call me.

This is bipartisan legislation — DeLauro, a Democrat, leads it as H.R. 7867, joined by Republican Jeff Van Drew of New Jersey — which tells you protecting infants from poisoned formula is not a left-or-right question. It is a question of whether we act on what these outbreaks have already taught us, or wait for the next three babies, or the next forty-eight.

Pass it. We turned the Jack in the Box tragedy into a rule that made hamburger safer for a generation of children; we can do the same for the formula we feed newborns. Then let’s make it so the next time someone like me goes looking for an infant formula case, there isn’t one to find. That has always been the goal — to put myself out of business by making food safe.

The full text of the Infant Formula Safety Modernization Act of 2026 is available here.

https://www.marlerblog.com/files/2026/06/Marler_Clark_Infant_Formula_Green_Columns.pdf

Today, Congresswoman Rosa DeLauro (CT-03) released a statement following the recall of Nara Organics Whole Milk Infant Formula. Three infants in California, Pennsylvania, and Washington have been hospitalized with botulism after consuming their formula.

“In just seven months, we have experienced two outbreaks of infant botulism tied to powdered infant formula.  First, a ByHeart outbreak which sickened 48 sick babies across 19 states, and now Nara Organics with babies in three different states – all of them between two and five months old – now fighting for their lives. Something we previously had not thought was likely, or even possible, now has now has caused two outbreaks with two separate companies within the same year.  

“This is not an isolated incident – it is a concerning pattern that begs the question; are we doing enough to ensure the safety of infant formula in this country? Before ByHeart and Nara Organics, in 2022,  there was Abbott’s facility in Sturgis, Michigan that shutdown after a cronobacter sakazakii outbreak, triggering a nationwide shortage that left families scrambling for formula and babies hospitalized and in some cases, dead. 

“The food we give our babies must meet the highest standard of safety. Right now it does not, and the gaps in the system are clear. It is time Congress take up my bipartisan Infant Formula Safety Modernization Act. Multiple crises year after year show the current system is not working, and we must be doing more. No family should have to wonder whether the formula in the can is safe, and no family should have to rush their baby to the hospital because the systems we put in place to protect them failed.

“Pass the Infant Formula Safety Modernization Act now.”

The Infant Formula Safety Modernization Act is endorsed by the American Academy of Pediatrics (AAP), Consumer Reports, Prolacta, Consumer Federation of America (CFA), Environmental Working Group (EWG), Center for Science in the Public Interest (CSPI), STOP Foodborne Illness (STOP), and the Association of Public Health Laboratories (APHL).

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

Consumer advisory expanded for all Clover Hill Dairy cheese products due to continued risk of foodborne illness

Baltimore, MD — The Maryland Department of Health announced today an expanded consumer advisory for all cheese products made by Clover Hill Dairy, located in Mechanicsville, Md., due to possible Listeria monocytogenes (L. monocytogenes) contamination. The facility has agreed to initiate a voluntary recall for all of its cheese products. 

The Maryland Department of Health previously issued a consumer advisory on June 3, 2026 for Clover Hill Dairy requesón/soft ricotta cheese products. Due to the public health risk, the Maryland Department of Health suspended the facility’s operating license on May 30, 2026, and is continuing a follow up evaluation in cooperation with the facility. 

Clover Hill Dairy products are sold directly from their retail market, at farmers markets, and through third party distributors, including in North Carolina, New York, Virginia, Maryland, New Jersey and Washington, D.C. Products may be relabeled under a different brand name when distributed, including but not limited to KESSO, QUESOS LA RICURA, IZALCO, DE MI PUEBLO, RIO LINDO. Consumers are urged to check the manufacturer information on packages, if available. The label should identify the Clover Hill Dairy manufacturer permit (or plant) number as “24-128”. 

Consumers, retailers and restaurants should not eat, sell or serve cheese products from Clover Hill Dairy, and should dispose of any product containing them. Written as they appear on Clover Hill Dairy products and pricing sheets, these cheeses include but are not limited to:

Soft and Semi-Soft “Spanish Style Cheese Varieties”

  • Cuajada
  • Soft Cuajada
  • Soft Cuajada in Brine
  • Soft Cujada Crumbs
  • Ricotta/Requeson
  • Soft Ricotta w/ Jalapeno’s (Requeson Con Chile)

Mild Cheese Varieties

  • Yummy Cheddar
  • White Cheddar
  • White Colby
  • Monterey Jack
  • Marble Jack
  • Fresh Cheddar Curd
  • Snack Pack – Assorted (White Colby, Marble Jack, and Yummy Cheddar)
  • 3-in-A-Pack – Assorted (White Colby, Marble Jack, and Yummy Cheddar)

Hard Cheese Varieties

  • Yummy Cheddar
  • White Cheddar
  • White Colby
  • Snack Pack Sharp Stix

Smoked Cheddar Cheese Varieties

  • Cheddar 
  • White Cheddar

Flavored Cheeses

  • Horseradish
  • Old Bay Cheddar

Pepper Cheese Varieties

  • Jalapeno Cheddar
  • Pepper Jack
  • Sizzlin’ Colby (with Habanero Peppers)
  • Snack Pack- Assorted Pepper Stix (Jalapeno Cheddar and Pepper Jack)
  • 3-in-A-Pack – Assorted (Jalapendo Cheddar, Pepper Jack, and Sizzlin Colby)

Smoked Pepper Cheese Varieties

  • Jalapeno Cheddar

To date, whole genome sequencing has identified a total of nine individuals across multiple states infected with this Listeria outbreak strain, including one death in Maryland that occurred in 2023. The Maryland Department of Health will not release additional information about the individuals to protect their privacy. 

L. monocytogenes is a type of disease-causing bacteria, part of the Listeria family, that can grow in unsanitary food production conditions, leading to contamination of the food. When people eat food contaminated with L. monocytogenes, they may develop a disease called listeriosis. It can survive and grow even under refrigeration, and can easily spread to other foods and surfaces. Pets can also spread the bacteria in the home if they eat food contaminated with L. monocytogenes.

Listeriosis can cause a range of symptoms that vary depending  on the severity and form of the illness. It can be serious and life-threatening, particularly for pregnant women, newborns and young children, older adults, and persons with weakened immune systems. Mild symptoms include fever, muscle aches, nausea, vomiting, and diarrhea, which often persist for 1 to 3 days. For the more serious form of the disease, symptoms may include headache, stiff neck, confusion, loss of balance, and convulsions. Although people can sometimes develop listeriosis up to 2 months after eating contaminated food, symptoms usually begin within several days. People should immediately consult with a healthcare provider if they suspect they have developed symptoms that resemble a listeriosis infection. 

Consumers at higher risk for Listeria illness should not eat any soft cheeses that are made with unpasteurized milk. Although pasteurization of milk kills Listeria, soft cheeses made from pasteurized milk can still become contaminated after the pasteurization process and cause Listeria illnesses. 

This represents the best information currently available to the Maryland Department of Health.

The Centers for Disease Control and Prevention (CDC), the U.S. Food and Drug Administration (FDA) and public health officials in several states are investigating a multistate outbreak of infant botulism linked to Nara Organics organic whole milk infant formula.

The company has voluntarily recalled the formula while the investigation continues. The recalled formula was sold nationwide through Target stores and online through Target.com and Nara.com between July 2025 – June 2026.

A Thurston County infant recently diagnosed with infant botulism consumed Nara Organics whole milk infant formula prior to onset of symptoms.

This is an active investigation.  For the most current updates, please see the CDC and FDA websites.

FDA Outbreak Investigation: Outbreak Investigation of Infant Botulism: Powdered Infant Formula, FDA 

CDC Outbreak Investigation: Infant Botulism Outbreak Linked to Powdered Infant Formula, CDC

In Washington

  • Cases: 1
  • Hospitalizations: 1
  • Deaths: 0
  • Status: Ongoing
  • Recall: Yes

Recall

Product Description:

  • Nara Organics Whole Milk Infant Formula, 700g, UPC 860013251901
  • Nara Organics Whole Milk Infant Formula, 400g, UPC: 860013251918

Lot Codes:
All lots currently on the market are included in the recall. Specific codes are as follows (and can be found on the bottom on the container):

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

About Infant Botulism

Infant botulism is a rare illness that usually occurs in babies through 6 months of age (it can occur in babies up to 1 year of age). On average, 4 cases of infant botulism are reported each year in Washington.

Infant botulism occurs when the baby ingests a bacteria called Clostridium botulinum which can make a toxin inside the digestive system. This toxin can cause the following symptoms:

  • Constipation
  • A weak or altered cry
  • Trouble swallowing
  • Weak muscles in the arms, legs, and neck
  • Floppiness
  • Difficulty holding the head up
  • Breathing problems

These bacteria are naturally present in dust and soil and babies can inhale or ingest the bacteria when they play on carpets or floors. The bacteria can also be naturally present in honey. Infants under 1 year of age should never be fed honey.

To Prevent Infant Botulism

  • A clear source is not identified for most cases of infant botulism.
  • Do not feed infants under 1 year of age honey or foods that contain honey.

More Resources

California Department of Public Health Infant Botulism Treatment and Prevention Program:

Infant Botulism Treatment and Prevention Program

Infant Botulism
 To report a suspected foodborne illness or file a complaint about unsafe food handling practices at an establishment in Washington, use the Foodborne Illness Notification System (FINS).

Advice to Consumers

Do not use recalled infant formula

  • If you have unopened cans of Nara Organics infant formula, throw them away or return them. If you have an opened can of Nara Organics infant formula, see guidance below.

Wash items and surfaces

  • Wash items and surfaces that may have touched the recalled formula using hot soapy water or a dishwasher.

Seek care if your infant becomes ill

  • Seek immediate medical care if your infant consumed Nara Organics infant formula and has any of these signs or symptoms of infant botulism: poor feeding, loss of head control, difficulty swallowing, decreased facial expression.

Report information to FDA

  • To report a complaint or adverse event (illness or serious allergic reaction), visit FDA’s Safety Reporting Portal. If your child has signs or symptoms of infant botulism, seek medical attention before using the portal.

What should I do if I have a leftover (opened) can of Nara Organics infant formula?

  • Take a picture and record the lot number and use-by date.
  • Consider keeping the formula. If your infant develops signs and symptoms of infant botulism, the state health department might want to test the formula.
  • If you keep the formula, write “DO NOT USE” on it. Keep it stored in a safe place away from other items you feed your baby for at least a month. If no symptoms appear after a month, throw the leftover formula away.

Advice to Businesses

  • Do not sell, donate, or use recalled infant formula.
  • Wash and sanitize items and surfaces that may have touched recalled formula.

What Clinicians Should Do

Initial diagnosis of infant botulism is based on clinical signs. If untreated, infants with infant botulism experience a progressive, flaccid paralysis that can lead to breathing difficulties, including respiratory failure, and require weeks of hospitalization. Consultation with the Infant Botulism Treatment and Prevention Program is available 24 hours a day, 7 days a week.

Actions to take

  • Call: If you suspect your infant patient has botulism, immediately call 510-231-7600 for case consultation.
  • Treat: Treatment with BabyBIG® is recommended for all suspected cases of infant botulism. If clinical consultation supports infant botulism, begin treatment as soon as possible. Do not wait for laboratory confirmation.
  • Notify: Infant botulism is a notifiable disease. Report all suspected cases to your local county public health department.

For Health Care Providers: Clinical Overview of Infant Botulism, CDC

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