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.”