Four More Babies, One Recalled Formula
Infant formula is the most heavily regulated food product sold in the United States. By federal law, every plant producing it must be inspected annually, and companies are required to test each batch for two specific bacteria — *Cronobacter* and *Salmonella* — before it can ship. No other food carries this kind of mandatory finished-product testing. Parents are told, and rightly so, that this makes formula the safest option for babies who aren’t breastfed.
Yet over the past year, infant formula has been linked to two separate outbreaks of infant botulism.
The current one has hospitalized four babies across California, Pennsylvania, and Washington, all after drinking Nara Organics Whole Milk Organic Powdered Formula, which was sold at Target and online between July 2025 and June 2026. Every lot has since been recalled. A California state lab detected the botulism bacteria in an opened can taken from a sick infant’s home, and the number of cases is expected to rise further.
Where the Contamination May Start
Less than a year earlier, a different brand, ByHeart, was responsible for the largest infant botulism outbreak in U.S. history — 48 babies sickened across 17 states, with 28 lab-confirmed cases, and every single one hospitalized. Three years before that, an Abbott facility in Michigan was linked to a *Cronobacter* outbreak that sickened four infants and killed two.
Two different brands, one year apart, the same illness. The natural question is whether the two incidents are related. The FDA has since confirmed that the Nara batches consumed by the sick infants used organic whole milk from the same supplier — Organic West Milk — which was dried into powder by the same company, Dairy Farmers of America, that also processed the milk powder used in ByHeart’s formula. That overlap doesn’t prove the supplier caused the contamination; no sealed Nara can has tested positive so far. But it’s why investigators are now looking further upstream, toward a shared ingredient source, rather than treating this as an isolated factory problem. Two premium formula brands, both marketed on cleanliness and safety, may have been sourcing from the same supply chain.
Hard to Catch, and Not Required
The bacteria responsible for sickening these infants, *Clostridium botulinum*, isn’t on the list of pathogens formula manufacturers are required to test for. A public health lab consulted during the ByHeart outbreak explained why the bacteria so often slips through: its spores are so sparse that detecting them would require testing hundreds of grams of powder — far more than a single scoop. That’s a genuine scientific challenge, but it also strengthens the case for doing more testing further upstream — screening raw ingredients, monitoring plant environments where contamination originates, and requiring immediate reporting of any positive result.
A Thinner System Meets a Second Outbreak
At the same time, the system’s capacity to enforce even its existing rules has been shrinking. Reporting on the ByHeart outbreak revealed what responders were up against: one state’s food safety team, which helps coordinate the national outbreak response, had its federal funding slashed by more than half and lost the staff member who managed that coordination. The same state had also lost a significant share of its disease investigators. Nationwide, roughly 40% of investigator positions dedicated to “critical foods” such as infant formula sit vacant, and a federal program responsible for verifying that food-testing labs can correctly identify pathogens was suspended. An advisory panel that had been researching which infants face the highest risk from the exact bacteria found at the Abbott plant was disbanded.
Even a recall doesn’t guarantee an outbreak stops. During the ByHeart incident, state inspectors conducted 124 checks to verify the recalled formula had been pulled from shelves — and still found it for sale in four stores.
The FDA, for its part, says it has tested more infant formula than ever before for heavy metals such as lead and arsenic, has more than doubled its infant formula staffing since 2022, created a new Office of Critical Foods, and continues to meet its annual inspection requirement. Even so, staffing was cut in 2025, and hiring was frozen.
The FDA did inspect manufacturing plants connected to Nara — but meeting the inspection requirement isn’t the same as catching the actual problem. The plants passed inspection, and babies still got sick, because neither the inspections nor current rules require anyone to specifically screen for botulism.
Testing, Monitoring, and Mandatory Reporting
The FDA has asked Congress to grant it authority to require companies to report a positive pathogen test even before contaminated formula leaves the warehouse. Under existing rules, a manufacturer can test a batch, discover a dangerous pathogen, and — so long as that batch hasn’t shipped — keep the finding to itself. The FDA wants the power to close that gap.
Congress currently has a bill that would do exactly that. The Infant Formula Safety Modernization Act, introduced in March by Representative Rosa DeLauro (D-CT) with bipartisan backing, would require the FDA to add *C. botulinum* testing, mandate 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 strengthen reporting requirements but doesn’t go as far on mandatory testing. The House bill has remained in committee since March — and a second outbreak occurred during that same stretch of time.
Last month, the Justice Department closed its years-long criminal investigation into the 2022 Abbott plant incident without filing any charges, partly because prosecutors couldn’t genetically match the plant’s bacteria to the sickened infants. Kyle Diamantas, the FDA’s Acting Commissioner, previously worked as a lawyer representing Abbott during that same 2022 crisis, and his recusal from infant formula matters expired in January. That timing is worth watching, though it isn’t evidence of wrongdoing on its own.
What Parents Can and Can’t Do
The safety of any can of formula ultimately depends on the milk supplier, the drying facility, the testing requirements, the inspectors, the outbreak-response labs, and whether a company is obligated to disclose what it finds. None of that is within a parent’s control. What parents are left with instead is a checklist: verify the lot number, watch for constipation, a weak suck, or a floppy head, and seek emergency care quickly if something seems wrong. That guidance remains sound, and parents should follow it.
Sterile, ready-to-feed liquid formula avoids the powder-contamination risk altogether, which is why the CDC recommends it for newborns and immunocompromised infants — though it comes at a higher price.
Parents can check a lot number and watch for warning signs like a floppy head, but they can’t test milk powder themselves, staff government labs, or move legislation forward. A second outbreak happened while Congress was still deliberating. And Nara formula stayed on store shelves until June.