Long before a public health investigation was opened, infants in homes across America were falling gravely ill from a product their parents trusted above all others. The ByHeart formula botulism outbreak, now confirmed across 15 states and at least 31 hospitalized babies, carries a quieter and more troubling dimension: cases stretching back to late 2024 that health officials say fell within expected ranges for a rare disease, yet which families and outside experts now believe were early warnings left unheeded. At the heart of this story is a recurring human tension — the gap between what insti
Parents Demand Answers as ByHeart Botulism Cases Predate Official Outbreak
At least 31 infants across 15 states hospitalized with botulism; affected babies experienced constipation, poor feeding, weakness, and lingering effects requiring intensive care treatment.
This cannot be a coincidence.
Mark
So we have at least 31 cases now, but some families are saying their babies got sick months earlier with the same illness from the same formula. Why didn't anyone connect those dots sooner?
Mimi
Because at the time, there wasn't enough evidence pointing to a common source. Botulism in babies is rare but not unheard of, and the earlier cases fell within the normal range. It wasn't until August that cases started clustering in a way that looked unusual—more cases, a toxin type rarely seen on the East Coast, and a pattern involving one brand.
Luke
But the CDC has now confirmed that unopened ByHeart cans contain the botulism bacterium. So if a baby drank ByHeart in March and got botulism, and a baby drank ByHeart in September and got botulism, why aren't those the same outbreak?
Mimi
That's exactly what the parents are asking. The CDC says they can't definitively link the earlier cases because so much time has passed and families may not have kept lot numbers or empty cans. But experts like Frank Yiannas from the FDA say that reasoning doesn't hold—if the product was contaminated, it was contaminated.
Mark
What does the timeline actually show? When did ByHeart know there was a problem?
Mimi
ByHeart didn't recall until November 11, after lab tests of unopened formula confirmed contamination. Before that, the company apparently didn't know or didn't act on what was happening. One mother, Katie Connolly, said she spent months trying to figure out why her daughter got sick in April before she even knew to suspect the formula.
Luke
So we have at least five documented cases before August, possibly more. We know the formula was contaminated. But the official outbreak count starts in August. That's a significant gap in how the story is being told.
Mimi
Right. And it matters because it changes how we understand when the contamination began and whether ByHeart had earlier warning signs. Parents are asking why their cases weren't investigated the same way.
Mark
What's the human cost here?
Mimi
Thirty-one infants hospitalized across 15 states. Botulism causes constipation, poor feeding, weakness. Some babies still have lingering effects. And the parents who went through this months ago are now dealing with the knowledge that their babies might have been preventable casualties.
Luke
The one thing we don't know yet is whether the contamination was present throughout the entire period or whether something changed in August. That's still an open question.
The Pulse
- Infants as young as a few months old were hospitalized with a paralyzing, life-threatening illness months before any public alarm was raised, leaving parents to search alone for answers that institutions were not yet asking for.
- ByHeart, a brand holding less than one percent of the U.S. formula market, has now recalled all products after laboratory tests confirmed contamination with botulism-causing bacteria in unopened cans — a first in the history of American powdered infant formula.
- Health officials maintain they cannot definitively link the pre-August cases to the current outbreak, citing missing lot numbers, inconclusive early tests, and a disease baseline that made earlier illnesses appear statistically unremarkable.
- Outside experts and food safety advocates are pushing back hard, arguing that any infant who consumed ByHeart formula and developed botulism belongs in the outbreak count, regardless of when the illness occurred.
- Affected families, whose children are slowly recovering but still bearing lingering effects, are demanding transparency — not just about what happened, but about why the signal took so long to be seen.
Long before a public health investigation was opened, infants in homes across America were falling gravely ill from a product their parents trusted above all others. The ByHeart formula botulism outbreak, now confirmed across 15 states and at least 31 hospitalized babies, carries a quieter and more troubling dimension: cases stretching back to late 2024 that health officials say fell within expected ranges for a rare disease, yet which families and outside experts now believe were early warnings left unheeded. At the heart of this story is a recurring human tension — the gap between what institutions can prove and what suffering families already know.
When Amy Mazziotti's five-month-old son fell ill in March 2025, doctors diagnosed him with botulism after weeks of drinking ByHeart formula. Katie Connolly's daughter was hospitalized in April with the same rare disease, linked to the same brand. Neither mother knew where the infection had come from — botulism in infants typically arrives through environmental spores, not formula. Then, on November 11, ByHeart recalled all its products nationwide, and Mazziotti understood immediately: this was no coincidence.
What followed was the emergence of a troubling gap in the outbreak's timeline. California officials confirmed six babies had been treated for botulism between November 2024 and June 2025 after consuming ByHeart formula — up to nine months before the August surge that would eventually sicken at least 31 infants across 15 states. At the time, officials said there was insufficient evidence to suspect a common source. Even now, they say they cannot definitively connect those earlier cases to the current investigation, despite laboratory confirmation of contamination in unopened formula cans.
Food safety lawyer Bill Marler, representing affected families, documented at least five pre-August cases. Connolly, who spent months searching for answers, asked the question many parents are now voicing: why did cases beginning in August trigger a federal investigation, but cases beginning in March did not? CDC scientist Dr. Jennifer Cope acknowledged awareness of earlier reports but said the unusual clustering of cases after August 1 — particularly on the East Coast, involving a toxin type rarely seen there, and disproportionately linked to ByHeart — was what made the signal clear.
Outside experts were less forgiving of the distinction. Former FDA deputy commissioner Frank Yiannas argued that any botulism case connected to ByHeart formula should be counted as part of the outbreak, full stop. Sandra Eskin of STOP Foodborne Illness emphasized the human weight of the crisis: parents who fed their newborns a product they believed was safe are now navigating hospitalizations and lasting illness with few answers.
Both Mazziotti and Connolly say their children are improving, though the effects of botulism — constipation, weakness, poor feeding — can linger long after discharge. The question now before health officials is whether the investigation will expand to encompass those earlier, quieter cases, or remain fixed on the August surge — and whether the families who spent months searching in the dark will finally be told what they were searching for.
When Amy Mazziotti's five-month-old son Hank fell ill in March 2025, doctors diagnosed him with botulism after weeks of drinking ByHeart formula. Katie Connolly's eight-month-old daughter was hospitalized in April with the same rare disease, also linked to the same brand. Neither mother understood where the infection had come from. Botulism in infants typically arrives through environmental spores or contaminated honey—not formula. Then, on November 11, ByHeart recalled all its products nationwide. The moment Mazziotti heard the news, she knew: this was no accident.
What emerged in the following days was a troubling gap in the outbreak timeline. California health officials confirmed that six babies in the state had been treated for botulism between November 2024 and June 2025 after consuming ByHeart formula—up to nine months before the surge that would eventually sicken at least 31 infants across 15 states beginning in August. At the time those earlier cases occurred, officials said there was insufficient evidence to suspect a common source. Even now, they maintain they cannot definitively connect the pre-August cases to the current outbreak. Yet laboratory tests of unopened ByHeart formula cans have since confirmed contamination with the bacterium that produces infant botulism toxin.
Bill Marler, a Seattle food safety lawyer representing affected families, documented at least five cases of babies who drank ByHeart formula and were treated for botulism before August. One infant consumed the formula in December 2024; two others fell ill in the spring. Connolly, whose daughter was hospitalized in April, said she spent months obsessed with finding answers, only to discover months later that the product itself may have been the culprit all along. "What I want to know," she asked, "is why did the cases beginning in August flag an investigation, but the cases that began in March did not?"
Dr. Jennifer Cope, the CDC scientist leading the investigation, acknowledged that federal officials are aware of reports of earlier illnesses but said the focus remains on the unusual surge documented since August 1. She noted that the strong signal connecting ByHeart to infant botulism only became apparent in recent weeks. Before this outbreak, no powdered infant formula sold in the United States had tested positive for the botulism-causing bacterium. The earlier cases fell within an expected range for the rare disease, which affects fewer than 200 infants annually in the country. A test of an open formula can fed to a sick baby in the spring did not detect the bacterium, complicating the picture further.
The shift came in late summer and fall. Beginning in August and continuing through October, more cases emerged on the East Coast involving a toxin type rarely seen in that region. The cases clustered in very young infants and disproportionately involved ByHeart, a brand that accounts for less than one percent of infant formula sold in the United States. When a sample from a ByHeart can fed to a sick infant tested positive for the contaminating organism, officials notified the CDC, FDA, and the public.
Cope acknowledged that the passage of time creates practical obstacles. Parents of babies who fell ill months earlier may not have saved lot numbers or empty formula containers, making it harder to definitively link those cases to the current outbreak. Yet outside experts questioned this reasoning. Frank Yiannas, former deputy commissioner for food policy and response at the FDA, said earlier cases involving ByHeart formula and botulism should absolutely be counted as part of the outbreak. "Why wouldn't they be included?" he asked. Sandra Eskin, chief executive of STOP Foodborne Illness, emphasized the human dimension: "This outbreak is traumatic for parents. They may have fed their newborns and infants a product they assumed was safe. And now they're dealing with hospitalization and serious illness of their babies."
Both Mazziotti and Connolly said their children are improving, though lingering effects remain. Botulism causes constipation, poor feeding, weakness in the head and limbs, and other complications that can persist long after hospitalization. Connolly said she deserves to know the data that explains how her daughter became sick. The question now facing health officials is whether the investigation will expand to include those earlier cases or remain narrowly focused on the August surge—and whether parents who spent months searching for answers will finally receive them.
Notable Quotes
What I want to know is why did the cases beginning in August flag an investigation, but the cases that began in March did not?— Katie Connolly, mother of an eight-month-old daughter hospitalized with botulism in April
Absolutely, yes, they should be included. Why wouldn't they be included?— Frank Yiannas, former deputy commissioner for food policy and response at the FDA, on whether earlier cases should count as part of the outbreak
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