Three babies — in California, Pennsylvania, and Washington — were hospitalized with botulism after being fed Nara Organics Whole Milk Organic Powdered Infant Formula. All three were between two and five months old. All three were treated with BabyBIG. On June 13, 2026, Nara recalled every lot.
I represent families in cases like these, and I have done it for more than thirty years. So let me be direct about the three things this case turns on. First, the risk of botulism in milk, powdered milk, and powdered infant formula was known — not in hindsight, but on the record, in writing, years before these babies got sick. Second, Nara dressed its product in words like “FDA-registered” and “2,000+ tests per batch” that do not mean what a frightened, sleep-deprived parent in a Target aisle would reasonably think they mean. And third, as the company that imported this formula from Europe, Nara had specific, federally mandated duties to find this hazard and make sure its supplier controlled it. From where I sit, representing the families, those duties were not met.
Botulism in powdered formula was not a danger nobody saw coming. Just the opposite.
On March 8, 2023 — more than three years ago — the FDA sent a Call-to-Action letter to the powdered infant formula industry. It was signed by the Commissioner of Food and Drugs and the Director of the Center for Food Safety and Applied Nutrition. And, critically, it was addressed by its own terms to manufacturers, packers, distributors, exporters, importers, and retailers. The letter told the industry, in plain language, to account for the historical associations between powdered infant formula and pathogens including Cronobacter, Salmonella, and Clostridium botulinum when designing safety controls. It named the bacterium by genus and species. Nara is a manufacturer and importer. This letter was written to companies exactly like Nara.
And none of this was new even in 2023. Go back to August 2013, when a single suspected botulinum contamination in whey protein concentrate from the New Zealand dairy giant Fonterra set off a precautionary recall across seven countries — roughly a thousand tons of product used to make infant formula and sports drinks. China ordered Abbott to pull baby formula off its shelves over the scare. It later turned out the organism was a non-pathogenic Clostridium, not C. botulinum at all. But that is precisely the point: more than a decade ago, the mere suspicion of botulinum in milk powder sent the global dairy and formula industry into a five-alarm panic — product yanked from seven countries, executives toppled. Nobody in this business can stand up and say the hazard was off the radar.
Then came the proof of concept. In November 2025, Clostridium botulinum in ByHeart Whole Nutrition Infant Formula — also a whole-milk-powder product — sickened 48 infants across 17 states. Federal and state investigators confirmed the link in the strongest way science allows — whole genome sequencing tied the strain in the whole milk powder to the strain in the finished formula to the strain in the sick babies. The FDA has publicly described its root-cause work on incoming ingredients such as powdered milk, and the agency pushed the Joint FAO/WHO expert body to open a formal risk assessment of spore-forming pathogens — including C. botulinum — in powdered infant formula.
Back in March 2025 — before Nara had sold a single can — the FDA and HHS launched a national infant-formula safety initiative they named Operation Stork Speed, built in part around increased testing of formula and its ingredients for contaminants. After ByHeart, the FDA folded the botulism lesson straight into that program. Its public Operation Stork Speed page now describes increased testing of infant formula and its ingredients for spore-forming microbiological contaminants, naming Clostridium botulinum and Bacillus cereus outright. And in February 2026 — months before the babies in this outbreak ever became ill — the FDA opened a sampling assignment aimed at exactly the ingredients at issue here: whole milk powder, non-fat dry milk powder, and whey protein concentrate. So, in the very window when Nara was selling whole-milk-powder formula to American families, the federal government was publicly testing that exact ingredient for that exact organism. Nara cannot claim it missed the memo, either. Its own marketing reached for the FDA’s companion contaminant program, “Closer to Zero,” to dress up its heavy-metals testing — while saying nothing about the spore-former the same agency was chasing through the same supply chain under the same banner.
Here is the part that matters most, and that Nara’s marketing never grappled with. Clostridium botulinum is a spore-former. The FDA has gone out of its way to explain the difference between spore-forming bacteria like C. botulinum and vegetative bacteria like Cronobacter and Salmonella: the vegetative organisms are killed by ordinary pasteurization, while botulinum spores survive pasteurization and persist in the environment. The spores live in soil and dust and walk into plants on hands and shoes. That is precisely why you cannot pasteurize your way out of this problem, and why the controls have to start with the milk and the supplier — not end with a reassuring number on a website.
When I ask what Nara should have known, the honest answer is: everything above. It was on the FDA’s letterhead in 2023. It was on the national news in late 2025. It was the subject of a federal testing program running in early 2026. The babies in this outbreak did not get sick until the spring of 2026.
Expect Nara to answer all of this with a single word: unprecedented. The FDA has described the 2025 ByHeart event as the first known instance of infant botulism tied to formula since the illness was first described roughly fifty years ago, and Nara will lean on that hard — no one could have predicted this. But foreseeability has never meant “this exact product did this exact thing before.” It means a careful company knew or should have known of the risk. And the danger that environmental C. botulinum spores pose to infants is not obscure science. It is the reason every pediatrician and every parenting pamphlet warns never to give honey to a baby under one year old. A company that builds infant food out of an agricultural powder — milk that comes out of barns and off of farms — did not need a prior formula outbreak to understand that the single most vulnerable population on earth for this organism was precisely the population it was feeding.
Walk through Nara’s own marketing and one phrase appears again and again: “FDA-registered.” It is paired with talk of a “first-of-its-kind” clinical trial and with the claim that the company performed that trial “in order to be FDA registered.” The clear impression — the intended impression — is that a federal agency vetted this formula, tested it, and blessed it as safe. That is not how infant formula works in this country, and Nara knows it.
The FDA’s own website could not be clearer: the agency does not approve infant formulas. Manufacturers must notify the FDA before marketing a new formula and must register, and the FDA reviews those submissions to confirm the product meets nutrient and certain other requirements. But registration and notification are not approval. They are not an FDA inspection of the actual factory in Germany. They are not an FDA seal of safety. And they are certainly not a finding that the product is free of Clostridium botulinum.
“FDA-registered” is a paperwork status. Nara turned it into a marketing virtue and let parents read it as a guarantee. That gap — between what the words say and what parents were led to believe — is exactly the kind of thing I intend to put in front of a jury.
There is a second sleight of hand tucked inside the same boast. Nara points to a large, first-of-its-kind, double-blinded clinical trial as proof of its formula’s “safety.” A new-formula clinical trial is a growth-and-tolerance study — it measures whether babies fed the formula grow normally and tolerate it. It is a nutrition study. It does not test for Clostridium botulinum, and it says nothing whatsoever about whether the powder in the can is free of spores. Presenting “clinically tested for safety” as a general assurance, when the trial never went near the hazard that actually hurt these children, is the same move as “FDA-registered”: a true-sounding credential standing in for a safety guarantee it was never designed to give.
Nara marketed itself on volume: 2,000-plus safety and quality tests on every batch, testing that “exceeds” minimums, an independent Purity Award. Read closely, and you see what that testing was actually aimed at — heavy metals, Cronobacter, pesticides, chemicals of concern. Those are real things to test for. None of them is the spore that paralyzed these babies.
Look at what Nara itself added to its recall page after the outbreak: a list of organisms it tests for that now includes Clostridium perfringens and Bacillus cereus and “other spore forming organisms.” Notice what is conspicuously absent from that list. The one spore-former at the center of this outbreak — Clostridium botulinum — is not named.
That same pattern runs through Nara’s proudest safety badge. The company trumpets a Clean Label Project “Purity Award” and testing for hundreds of “chemicals of concern.” But the Clean Label Project, by its own description, screens for heavy metals, pesticide residues, and plasticizers — chemical and environmental contaminants. It does not test for pathogens; the organization openly frames itself as covering the ground that pathogen-focused food safety leaves out. The very award Nara waves to signal “safe” is, by definition, silent on the microbial spore that put three babies in the hospital. It is a purity seal for chemicals, marketed as a safety seal for everything.
And here is the deeper problem, which the FDA has said out loud: testing a finished can of powder for botulinum spores is not a reliable safety net. The spores are sparse and unevenly scattered; the FDA notes that detecting them requires specialized methods, takes two weeks or more, and that the presence or absence of spores in a sample is not by itself determinative of risk. That is the whole point. You do not protect infants from this hazard by testing your way to a clean certificate at the end of the line. You protect them by controlling the milk and the manufacturing — upstream, where the spores enter. A company that sells parents on “2,000+ tests” is selling reassurance the science does not support, while the actual control that mattered was somewhere else entirely.
This formula was not made by Nara — though Nara will be held to a manufacturer’s standard. It was made in Germany and imported into the United States by Nara Organics. Nara would like the conversation to stop at “made in Germany to EU standards.” The law does not let it stop there.
When you import food into the United States, you are the Foreign Supplier Verification Program importer under the FDA’s rules — 21 CFR Part 1, Subpart L, the regulations Congress required in the Food Safety Modernization Act. Those rules are not a formality. They require the importer to develop and follow a program that gives adequate assurance that its foreign supplier is making the food under controls that provide at least the same level of public health protection as U.S. preventive-controls law, and that the food is not adulterated. The importer must conduct a hazard analysis to identify the known or reasonably foreseeable hazards for that food. It must evaluate the risk. And it must verify — through audits, sampling, records review, and supplier approval — that the foreign supplier is actually controlling those hazards.
Read that standard again: known or reasonably foreseeable hazards. After a 2023 FDA letter addressed to importers that named Clostridium botulinum, and after the ByHeart outbreak made the front page, botulinum in whole-milk-powder infant formula was the definition of a known or reasonably foreseeable hazard. Nara’s hazard analysis was supposed to catch it. Its supplier-verification program was supposed to confirm the German manufacturer controlled it.
What makes this worse is that Nara told parents it was doing exactly this kind of diligence. The company advertised “extremely high standards for working with a supplier,” “full evaluations of every ingredient partner,” and “full control over our manufacturing.” Yet to this day Nara has refused to publicly name the German manufacturer that actually made this formula. You cannot square a public promise of rigorous supplier verification with a refusal to even identify the supplier. The FSVP rules exist precisely so that the company putting its brand on the can — the company taking the parents’ money — cannot point overseas and shrug.
I am not interested in hindsight, and the families I represent cannot spend it. What I am interested in is accountability for a sequence that was foreseeable at every step: a hazard the government put in writing in 2023, that a near-identical outbreak proved in 2025, and that the FDA was sampling this very milk powder to catch by early 2026 — attached to an ingredient Nara marketed as its premium selling point, sold under words like “FDA-registered” and “2,000+ tests” engineered to make parents feel safe, by an importer that owed these children a legal duty to find this exact risk and stop it.
It is also why I have called on Congress to pass Representative Rosa DeLauro’s Infant Formula Safety Modernization Act, which would, for the first time, require testing for Clostridium botulinum and mandate environmental testing inside the plants that make this formula — the upstream controls that finished-product marketing can never replace.
The parents of these babies trusted a label. They were entitled to the truth behind it.