Multiple brands of infant formula have been recalled in the United States over bacterial contamination, including two cases tied to active botulism outbreaks, and the agency legally required to prevent exactly this kind of disaster has, by its own admission, lost 3,100 employees. This is not a coincidence. This is a policy choice with a body count forming around it.
Operation Stork Speed, Meet Operation Stalled Completely
Back in March of last year, the FDA launched what it called Operation Stork Speed, a program specifically designed to "expand options for safe, reliable, and nutritious infant formula for American families." Great branding. Genuinely important mission. Here is what happened next.
Two months after the launch, then-FDA Commissioner Martin Makary told Congress the agency had lost roughly 3,100 employees due to Trump administration cuts and reorganization. Then Makary himself left. According to The Guardian, Tom Brenna, a professor at the Dell School of Medicine with expertise in pediatrics and food science, was brought on to help design nutrition regulations for the program. His assessment of its current status is not encouraging. "I regret to say there has not been any movement on Operation Stork Speed since the summer of 2025, at least none that I know of," Brenna told The Guardian by email.
An FDA spokesperson insisted the initiative is "continuing as planned." The agency released one related report in April, on forever chemicals in infant formula. One report. In over a year. While babies were being hospitalized.
Botulism, Two Brands, One Shared Supplier Nobody Talked About
Here is where the story gets both more specific and more alarming. The Guardian's reporting traces two separate botulism-linked recalls back to a single shared ingredient supplier that neither company knew they had in common until the FDA posted an update in late June.
In November of last year, ByHeart recalled its infant formula following a botulism outbreak linked to 48 hospitalizations across 17 states. Then, earlier this month, Nara Organics voluntarily recalled its formula. In late June, a lawsuit was filed against Nara Organics on behalf of a baby who allegedly contracted botulism from its product. A June advisory from the California Department of Public Health linked three cases of infant botulism from late April and May to Nara Organics formula.
The connection between the two brands? Both used whole milk powder from a company called Organic West, which manufactures in Nevada. ByHeart formula is made in Iowa. Nara Organics formula is made in Germany. A spokesperson for ByHeart told The Guardian their company only learned of the shared supplier when the FDA posted its June 26 update, saying the "root cause investigation is shifting to now focus on third-party ingredients." So two brands, two outbreaks, one supplier, and the agency responsible for connecting those dots did not do it until journalists started asking questions.
The Inspection Numbers Are a Disaster
Let's talk about what "dramatically reduced" actually looks like in practice, because the FDA spokesperson's language is doing a lot of work to obscure something genuinely damning.
Sarah Mayne, former director of the FDA's Center for Food Safety and Applied Nutrition across three presidential administrations and now a professor of public health at Yale, told The Guardian the agency's ground-level workforce for inspecting facilities and preventing contamination is "especially lacking infant formula investigators." The FDA did not respond to The Guardian's specific questions about cuts to those inspectors.
The gap gets illustrated in congressional testimony from April. Steven Mandernach, executive director of the Association of Food and Drug Officials, told Congress that during the first week of the ByHeart recall response, states conducted nearly 2,000 recall checks. The FDA conducted 21. Not 2,100. Twenty-one. States are picking up the slack, except they do not always communicate with each other about shared contamination risks across state lines, and the Trump administration's restrictions on interstate communication are making that coordination harder, according to a source with FDA expertise who spoke to The Guardian anonymously.
The FDA Inspection Database Had a Hole in It
The Guardian flagged something else that deserves attention. When the outlet requested comment from the FDA on June 25, among the questions was why there was no recent information about Nara Organics' German manufacturing facility in the FDA's public inspection database. The next day, the FDA posted a report online noting it had inspected the facility and "found deficiencies," and that the manufacturer had submitted "corrective action" currently under review.
A Nara Organics spokesperson confirmed their facility underwent a routine FDA audit in May 2026, characterized the findings as three observations the FDA suggested be remedied through voluntary corrective actions, and said the FDA did not recommend pausing or stopping formula production. The FDA has said there is currently insufficient evidence to conclude whole milk powder was definitively the contamination source, and investigation into root causes through supply chain assessment is ongoing.
So the inspection happened. The deficiencies were found. Corrective actions were submitted. And none of this was publicly visible until a news organization asked about it during an active outbreak investigation. How exactly is that a system that is working as designed?
States Are Doing the FDA's Job, Badly and Separately
Mayne told The Guardian that states have taken on significantly more responsibility for food safety regulation as the FDA's capacity has shrunk. That sounds like a functional workaround until you understand the structural problem with it.
States do not share a unified food safety communication infrastructure. When contamination crosses state lines, which it did in both of these cases, the patchwork response is slower and less coordinated than federal oversight would be. Mandernach's congressional testimony specifically warned that increased reliance on state regulators, combined with restrictions on interstate communication the current administration has put in place, could slow down exactly the kind of coordinated safety response these outbreaks require.
And it is not just domestic formula. Mayne and the source familiar with FDA operations told The Guardian the teams responsible for imported food safety are in an especially precarious position. Earlier this year, the European Union announced a precautionary global recall of infant formula tied to concerns about cereulide, another bacterial contamination risk. Four months later, the FDA issued a recall alert for a2 Platinum Premium infant formula. The pipeline for catching problems coming from overseas is, by expert accounts, badly understaffed.
The Dingo Take
The FDA spokesperson told The Guardian the administration "more than doubled its infant formula staffing" and pushed Congress to require companies to report positive pathogen test results. Let's be extremely generous and take that at face value. The agency still lost a net 3,100 employees. The flagship infant formula safety initiative has produced one report in a year. States are doing the inspection work at a 95-to-1 ratio versus the federal agency legally mandated to do it. If doubling the infant formula team means you went from two inspectors to four, that is not a defense, that is an indictment.
The Trump administration made a deliberate decision to hollow out the regulatory infrastructure that keeps infant formula safe. It is not a mystery that these recalls happened. Infant formula safety has long been considered mission critical by the FDA, which is supposed to require annual inspections of every manufacturer. The agency clearly cannot do that job with what it has left. Experts who built the system over decades are saying so, clearly and on record.
Babies are being hospitalized with botulism. The response from the federal government has been 21 inspection checks, a database with visible gaps, and a press office that updates the public record only when reporters start asking inconvenient questions. The people who made these cuts knew what the FDA was for. They cut it anyway. That is the story.
