Why baby formula keeps causing botulism outbreaks
Two outbreaks in a year, the same milk supplier, and a pathogen the FDA doesn’t require companies to test for.
Four more babies, one recalled formula.
Infant formula is the most heavily regulated food in the United States. Federal law requires every plant that makes it to be inspected every year. It requires companies to test each batch for two specific bacteria, Cronobacter and Salmonella, before it ships. It is the only food that carries that finished-product testing mandate. Parents are told, correctly, that this is the safest way to feed a baby who isn’t breastfed.
But in the last year, infant formula has caused two outbreaks of infant botulism.
The current one has sickened four babies in California, Pennsylvania, and Washington, all hospitalized, after they drank Nara Organics Whole Milk Organic Powdered Formula. It was sold at Target and online from July 2025 to June 2026. Every lot has been recalled. California’s state lab found the botulism bacteria in an opened can taken from a sick baby’s home. The count is likely to grow.
Where the contamination may start.
Less than a year ago, a different brand, ByHeart, caused the largest infant botulism outbreak in U.S. history: 48 babies sickened across 17 states, 28 of them lab-confirmed, every one hospitalized. Three years before that, an Abbott plant in Michigan was tied to a Cronobacter outbreak that sickened four infants and killed two.
Two brands, one year, same disease. The obvious question is whether they are connected. The FDA has now confirmed that the Nara lots that the sick babies drank were made with organic whole milk from the same supplier, Organic West Milk, dried into powder by the same company, Dairy Farmers of America, that produced the milk powder in the ByHeart formula. That does not prove the supplier is the source. No sealed can of Nara has tested positive yet. But it is why investigators are now looking upstream, at a shared ingredient, and not just at one factory. Two premium brands, marketed as cleaner and safer, may have been drawing from the same pipeline.
Hard to catch, and not required.
The bacteria that sickened all these babies, Clostridium botulinum, is not on the list of pathogens that formula makers are required to test for. One public health lab I spoke with during the ByHeart outbreak explained why it’s so easily missed. The spores are so sparse you’d have to test hundreds of grams of powder, a lot more than a scoop, to find them. That’s a real scientific problem. It is also an argument for doing more upstream, not less: testing the ingredients, monitoring the factory environment where contamination starts, and requiring companies to report a positive result the moment they get one.
A thinner system meets a second outbreak.
Meanwhile, the capacity to implement even what’s required is shrinking. When I reported on the ByHeart outbreak, the people fighting it told me what they were working with. One state’s food safety team that helps run the national outbreak response had seen its federal funding cut by more than half and lost the staffer who coordinated it. That state had also lost a chunk of their disease detectives. Nationally, about 40% of the investigator positions for "critical foods" like infant formula sit vacant, and a federal program that checks whether food testing labs can correctly identify pathogens was suspended. An advisory committee that had been studying which babies are most at risk from the exact bacteria found at the Abbott plant was disbanded.
A recall doesn’t necessarily stop an outbreak either. During the ByHeart outbreak, state inspectors ran 124 checks to confirm the recalled formula was off the shelves. They still found it for sale in four stores.
At the same time, the FDA says it has tested more infant formula than ever before for heavy metals like lead and arsenic, has more than doubled its infant formula staffing since 2022, has established a new Office of Critical Foods, and continues to meet its annual inspection mandate. Staffing was then cut in 2025, and hiring was frozen.
The FDA inspected manufacturing plants tied to Nara, but meeting the inspection mandate is not the same as catching the problem: the plants were inspected, and the babies got sick anyway, because inspection plus the current rules don’t require anyone to look for botulism.
Testing, monitoring, and mandatory reporting.
The FDA has asked Congress for the authority to require companies to report a positive pathogen test even when the tainted formula hasn’t left the warehouse. Under current rules, a manufacturer can test its product, find a dangerous pathogen, and, as long as the batch hasn’t shipped, keep that result to itself. The FDA is asking for the power to change that.
Congress has a bill that would. The Infant Formula Safety Modernization Act, introduced in March by Representative Rosa DeLauro (D-CT) with support from both parties, would direct the FDA to include C. botulinum testing, require environmental monitoring at every plant, and require companies to disclose positive test results. A separate Senate bill, the Protect Infant Formula from Contamination Act, would tighten reporting requirements, though it stops short of that testing mandate. The House bill has been in committee since March, and during that time, a second outbreak occurred.
Last month, the Justice Department closed its years-long criminal investigation of that 2022 Abbott plant without filing charges, in part because prosecutors couldn’t genetically match the plant’s bacteria to the infants who got sick. Kyle Diamantas, the FDA’s Acting Commissioner, is a former lawyer who represented Abbott during that 2022 crisis. His recusal from infant formula matters expired in January. That's a connection worth watching, but isn't proof of anything.
What parents can and can’t do.
The safety of a can of formula depends on the milk supplier, the drying plant, the testing rules, the inspectors, the outbreak labs, and whether a company has to tell anyone when it finds something. A parent controls none of those. What a parent is offered instead is a list of chores: check the lot number, watch for constipation and a weak suck and a floppy head, get to an emergency room fast. That advice is correct, and parents should follow it.
Sterile, ready-to-feed liquid formula skips the powder problem entirely, which is why the CDC recommends it for newborns and immunocompromised infants, but it also costs more.
Parents can check a lot number and watch for a floppy head, but they can’t test the milk powder, staff the labs, or move a bill. A second outbreak arrived while Congress waited. And Nara formula remained on shelves until June.