FDA says infant formula 'safe.' Parents whose babies got botulism want answers

The U.S. Food and Drug Administration claimed its sweeping test results confirm America's infant formula supply is safe.

Our investigation uncovered a glaring omission from that report: a deadly, spore-forming pathogen - hospitalizing babies- found in infant formula that the agency was actively investigating at the very same time it told American consumers the supply was safe.

Now, we're investigating what the FDA knew, why it took no meaningful action on warning signs, and the questions the agency still refuses to answer.

RELATED | FDA says infant formula is safe; Critics say agency left out key information

When we met Katie Connolly, she was weeks away from meeting her newborn son. Her nursery was ready, but one critical choice hung over her head.

"I don't have confidence that if I were to pull a bottle or a can of formula off of the shelf and feed it to my son when he's born, that I would feel safe," she said.

Connolly's fear comes from a terrifying experience. In 2024, her 8-month-old daughter, MJ, suddenly couldn't move.

Rushed to the ER, her baby was put on an IV, catheter, and a feeding tube, as doctors raced to figure out what was happening.

"All of those instances were horrifying and she was so weak that she couldn't cry," Connolly said, choking back her own tears.

Doctors told Connolly her daughter had botulism.

Thanks to a lifesaving anti-toxin, MJ recovered from the paralysis that America would later learn was tied to a botulism outbreak in infant formula.

The FDA has been aware of the threat of botulism in formula for years.

In 2023, it issued a warning to the infant formula industry about the potential for botulism, revealing it had already conducted investigations "among infants who'd consumed powdered infant formula."

We examined an FDA database and found botulism reports potentially linked to infant formula going back more than 20 years.

Attorney Bill Marler represents Katie and multiple other families, and said based on that history, the outbreaks were preventable.

In the months after MJ's diagnosis, dozens more babies were hospitalized in the botulism outbreak linked to ByHeart formula.

Newly obtained documents show what the FDA was doing at the same time:

On Nov. 20, 2025, FDA and CDC officials spoke with ByHeart about the outbreak investigation.

Four days later, the FDA collected formula samples from ByHeart, not because of the outbreak, but for inclusion in what it called the "largest and most rigorous" contaminant testing of infant formula in U.S. history.

The FDA did not test those samples, or any of the study samples, for pathogens.

Even as the FDA was investigating a botulism outbreak, it was excluding in its forthcoming report the very thing at the center of the crisis: disease-causing pathogens.

Sandra Eskin, the former head of Food Safety at the USDA, and now CEO of the non-profit Stop Foodborne Illness, said an important message was lost when the FDA later used those tests to declare the infant formula supply "safe."

Eskin pointed out that the threat from pathogens isn't new. In 2022, there was a national recall and shortage of infant formula because of a different deadly pathogen: Cronobacter.

Fast forward to 2025 - weeks after the FDA declared America's supply "safe," and while still investigating the ByHeart botulism outbreak with nearly four dozen babies hospitalized, more cases surfaced. This time, from a different company: Nara Organics. Four infants were hospitalized, another nationwide recall was issued, and there were still no answers about where the botulism came from.

We filed multiple public records requests, trying to find out what the agency was doing behind the scenes and what it knew as the botulism outbreak unfolded.

Each time we asked the FDA to expedite our request, arguing the records were urgent because babies could still be at risk. Each time, within hours, the FDA denied the requests for expedited processing.

We also posed the below questions directly to the FDA, concerning the Operation Stork Speed infant formula safety report:

The agency did not respond.

Connolly recalled becoming an "investigator," calling federal agencies and ByHeart, looking for answers.

"I've still never heard from the FDA," said Connolly.

Today, she and dozens of other parents are left wondering how the FDA could say infant formula is safe, when the agency never tested for the very thing that put 52 babies in the hospital.

MJ is two years old now. Her mom keeps a vial of the antitoxin that saved her life as a reminder of the terrifying moments that changed their lives forever.

The FDA said its investigation into the root cause is ongoing. We'll be taking a closer look at that in the coming weeks.

Both Nara and ByHeart said they're changing suppliers and enhancing testing to make formula safer. You can read their full statements below.

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ByHeart recently announced that it provided the FDA with an "approximately 400-page comprehensive submission" about the company's investigation into the matter and said the FDA had no further questions. It declined to provide that report to us.

It sent us this statement:

"We take our responsibility to ByHeart families incredibly seriously, and we are deeply sorry for the impact this outbreak has had on our community. Nothing is more important to ByHeart than the health and safety of babies. Since the recall, we have focused on investigating the root cause, strengthening safeguards, advancing testing, and working with FDA and independent food safety experts. We are turning those learnings into a practical playbook others can use—sharing what the science revealed, where existing approaches must evolve, and how stronger testing and prevention can close gaps. Our goal is not only to make ByHeart safer, but to help advance the science of safety across infant formula so the entire category can learn faster and better protect babies.”

Nara Organics sent us the following statement:

"You can read the latest update from Nara HERE. Additional updates and information are all available on their website, including information about their safety and testing protocols (pre-recall), and dairy supplier.

In this complex and evolving situation, Nara is committed to working diligently alongside the Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), and state health departments in the root cause investigation."