ByHeart Baby Formula Botulism Outbreak Expands Nationwide

When news first broke about an infant botulism outbreak linked to ByHeart baby formula, few imagined the scale it would eventually reach. But as federal health officials revealed this week, the crisis is much more widespread than initially believed—stretching across 19 states, spanning nearly three years, and affecting at least 51 infants. The ramifications are rippling through families, regulatory agencies, and the entire infant formula industry.

According to the U.S. Food and Drug Administration (FDA), the outbreak now encompasses every reported case of infant botulism in babies who consumed ByHeart formula since the company began production in March 2022. The Centers for Disease Control and Prevention (CDC) broadened their case definition to include "any infant with botulism who was exposed to ByHeart formula at any time since the product’s release." The most recent illness was reported on December 1, 2025, and, as of December 10, a total of 51 infants have been hospitalized—though, thankfully, no deaths have occurred.

For many parents, the news has been nothing short of devastating. Andi Galindo, whose five-week-old daughter Rowan was hospitalized with infant botulism in December 2023, told the Associated Press, "That’s a hard one. If there is proof that there were issues with their manufacturing and their plant all the way back from the beginning, that is a problem and they really need to be held accountable." Amy Mazziotti, another parent, echoed that sentiment: "I’ve known in my gut from the beginning that ByHeart was the reason Hank got sick, and to see that these cases are now part of the investigation brings me to tears—a mix of relief, gratitude and hope that the truth is finally being recognized."

ByHeart, a New York-based manufacturer founded in 2016, had positioned itself as a premium, organic alternative in the crowded infant formula market. The company quickly gained a following, selling about 200,000 cans a month and accounting for roughly 1% of the U.S. market. Its products were even distributed internationally, reaching consumers in countries from Canada to China, Argentina to South Africa, according to FDA and Amazon data.

But trouble began brewing in August 2025, when California’s Infant Botulism Treatment and Prevention Program noticed a spike in cases involving infants who had consumed ByHeart formula. Laboratory testing soon detected the presence of Clostridium botulinum, the bacterium responsible for infant botulism, in 36 samples from three different production lots. As reported by the Associated Press, ByHeart admitted, "We cannot rule out the risk that all ByHeart formula across all product lots may have been contaminated."

Regulators moved quickly. On November 11, 2025, ByHeart issued a sweeping recall of all its infant formula products sold in the United States. The FDA sent inspectors to the company’s plants in Allerton, Iowa, and Portland, Oregon, where the formula is produced and packaged. The agency has yet to release the full results of those inspections, but the company’s own history is troubling: In 2022, ByHeart recalled five batches of formula after a sample at a packaging plant tested positive for Cronobacter sakazakii, a different dangerous germ. The following year, the FDA sent a warning letter highlighting "areas that still require corrective actions," and a ByHeart plant in Reading, Pennsylvania, was shut down after inspectors found mold, water leaks, and insects.

With the outbreak now traced back to March 2022, the CDC and FDA have identified cases in Arizona (5), California (12), Idaho (2), Illinois (2), Kentucky (1), Massachusetts (2), Maine (1), Michigan (1), Minnesota (3), North Carolina (2), New Jersey (1), Ohio (1), Oregon (4), Pennsylvania (1), Rhode Island (1), Texas (8), Virginia (1), Washington (2), and Wisconsin (1). All 51 affected infants were hospitalized, with ages ranging from just 16 days to nearly nine months old. About 43% of the cases involved female infants.

Infant botulism itself is rare—fewer than 200 cases are reported in the U.S. each year, according to CDC data. The disease occurs when babies ingest spores of Clostridium botulinum, which germinate in their intestines and produce a potent neurotoxin. The symptoms, which can take up to 30 days to appear, are frightening: constipation, poor feeding, loss of head control, drooping eyelids, a flat facial expression, muscle weakness, and, in severe cases, difficulty swallowing or breathing.

The only treatment, known as BabyBIG, is an intravenous medication developed by California’s infant botulism program. It’s made from the pooled blood plasma of adults immunized against botulism, and it’s the sole source worldwide. Dr. Sharon Nachman, a pediatric infectious disease expert at Stony Brook Children’s Hospital, explained, "The risk to the infant is ongoing and the family should not be using this formula after it was recalled."

While the acute symptoms of botulism can be treated, the long-term effects are not insignificant. According to research summarized by Marler Clark, a law firm representing 30 families affected by the outbreak, "Even several years after acute illness, patients who had botulism were more likely than control subjects to experience fatigue, generalized weakness, dizziness, dry mouth, difficulty lifting things, and difficulty breathing caused by moderate exertion." Some children may face lasting health and psychosocial challenges.

The legal and regulatory fallout has been swift. Families of affected babies have filed lawsuits against ByHeart, alleging that the company’s formula was defective and that it was negligent in selling it. They are seeking compensation for medical bills, emotional distress, and other damages. Marler Clark, which specializes in foodborne illness litigation, has been retained by dozens of families. The FDA, CDC, and state health agencies continue to investigate the root cause of the contamination, with additional testing underway and results expected in the coming weeks.

ByHeart, for its part, says it is cooperating with federal officials "to understand the full scope of related cases." In a statement, the company noted, "The new cases reported by CDC and FDA will help inform ByHeart’s investigation as we continue to seek the root cause of the contamination."

For now, the message from public health authorities is clear: Parents and caregivers should not use any ByHeart infant formula, regardless of test results or lot numbers. The recall includes all formula cans and single-serve "anywhere pack" sticks. As of late November, the FDA has not found any recalled formula on store shelves, but the warning extends to consumers worldwide, given the product’s international reach.

This outbreak, the first of its kind linked to powdered infant formula in the U.S., has shaken confidence in a sector that parents trust with their babies’ lives. As the investigation continues, families, regulators, and the company itself are left grappling with difficult questions about safety, oversight, and accountability in the food supply chain.

With federal agencies still searching for answers and families seeking justice, the ByHeart botulism outbreak stands as a sobering reminder of the stakes when it comes to infant nutrition and public health.