For the second time in seven months, I am writing about infant formula containing a toxin that causes botulism. For the second time in seven months, the ingredient involved is whole milk powder. And for the second time in seven months, the product was sitting on Target store shelves when parents went to pick it up.
On June 13, 2026, Nara Organics recalled all cans of its whole milk organic powdered infant formula after the FDA and CDC linked it to three cases of infant botulism in California, Pennsylvania, and Washington. All three babies, aged between 2 and 5 months old, were hospitalized and treated with BabyBIG. Fortunately, no one died. The formula is manufactured in Europe and sold nationwide through Target stores, Target.com and Nara.com from July 2025 to June 2026.
If that sounds familiar, it is. In November 2025, a ByHeart Whole Nutrition infant formula outbreak sickened 48 infants in 17 states. This was the first infant formula-related outbreak of infant botulism in this country. Whole genome sequencing has linked *Clostridium botulinum* to organic whole milk powder. Our firm represents more than 20 of those families. I sat with them. There is nothing abstract about an infant on a ventilator.
I have a simple question. I think every parent in America deserves to ask me this question. “Where is the FDA and the formula industry making sure the formula we feed our children is safe?” I intentionally put both in the same sentence. One of them wrote a warning. Someone else got it. No one could stop this from happening. Twice.
They have been warned. Writing. Name the toxin.
This is what makes me angry, and it should make you angry too. None of this came as a surprise to the agency or the industry.
More than three years ago, on March 8, 2023, the FDA sent a “call to action” letter to all infant formula manufacturers, packagers, distributors, exporters, importers, and retailers in the United States. In the letter, signed by the Commissioner of the Food and Drug Administration and the director of the Center for Food Safety and Applied Nutrition, the FDA wrote, using plain language and the names of the organisms, that “(h)the historical association between powdered infant formula and pathogens such as Cronobacter species, Salmonella, and Clostridium botulinum should be considered when designing and implementing controls for the safe manufacture of all foods for infants and young children.”
Read it again. In an industry-wide letter, the FDA said there is a documented history of botulism in powdered infant formula, naming it Clostridium botulinum, and that manufacturers must control it.
That was in 2023. And in 2025, By Heart came. The country is now in 2026.
It’s not bad luck if regulators hand the industry a road map of exactly how children will get hurt, and then children get hurt in exactly that way (twice in seven months). It was predictable. Prevention was possible. And it keeps happening.
And let me be clear about who got that roadmap. The March 2023 letter was not delivered to the public. It was aimed at manufacturers, packers, distributors, importers, retailers – the industry itself. The FDA did its job. We identified the risks and instructed people who make and sell these products in writing to control them. The companies that make infant formula and the retailers that put it on their shelves received accurate warnings three years before these babies got sick.
Recalls are not a food safety system
This is what I want people to understand. By the time you read the recall notice, the damage has already been done. The babies are already in the hospital. Recall is not a food safety system. It’s a bad apple.
What parents should do right now
If you have Nara Organic whole milk organic powdered milk at home, stop using it starting today. Don’t throw it away yet. Label the container “Do not use”, take a photo of the label and lot code, and store it safely separate from other foods for at least a month as it may be tested by your state health department.
Infant botulism often starts quietly, with constipation, poor feeding, weak crying, loss of head control, and difficulty swallowing. This may progress to difficulty breathing. It may take several weeks for symptoms to appear after consuming formula. If your baby is having trouble feeding, is unable to lift his or her head, or seems unusually weak or lethargic, don’t wait. Call your doctor now. Physicians who suspect infant botulism can contact the Infant Botulism Treatment and Prevention Program at 510-231-7600, 24 hours a day, 7 days a week.
30 years and the same lesson
I have been doing this for over 30 years, since the Jack in the Box incident in 1993. The lesson has never changed. The outbreak is not an accident. This is the predictable result of a known risk left uncontrolled. The only thing that has changed here is that the FDA has put warnings in writing, named the toxins, and communicated them to industry. Anyway, the kids got sick.
I hope babies in California, Pennsylvania, and Washington recover. But the next parents standing down the aisle deserved to have a system in place to protect their children *before* the recall. This is a system where, rather than giving the industry a warning letter, two outbreaks, and a call for the rest of us to check our pantries, the agency demands real prevention and the companies actually deliver it.
Where is the FDA and the formula industry? That’s the problem. Our children are waiting for answers.
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