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Parents say infants who drank Bayheart formula fell ill months before botulism outbreak

KANIKA SINGH RATHORE, 22/11/202522/11/2025

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As health officials investigate more than 30 cases of infant botulism linked to Bayheart baby formula since August, parents who say their children were sick with the same illness months before the current outbreak are also demanding answers.

California Public health officials confirmed late Friday that six infants in that state who consumed Bayheart formula were treated for botulism between November 2024 and June 2025, nine months before the outbreak that has sickened at least 31 infants in 15 states.

The California Department of Public Health said in a statement that, at the time, “there was not enough evidence to immediately suspect a common source.”

“Even now, we cannot link any cases before August 1 to the current outbreak,” officials said.

According to reports shared by Bill Marler with The Associated Press, parents of at least five infants said their infants were treated for a rare and potentially fatal disease after drinking Bayheart formula in late 2024 and early 2025. seattle Food safety attorneys representing families.

Amy Mazziotti, 43, of burbankCalif., said her 5-month-old son, Hank, fell ill and was treated for botulism in March, just weeks after he began drinking bottles filled with Bayheart formula.

Katie Connolly, 37, of Lafayette, California, said her daughter MC, then 8 months old, was hospitalized in April and treated for botulism after feeding her Bayheart formula in hopes of helping the baby sleep.

For months, neither mother had any idea where the infection might originate. Such diseases in infants are usually caused by spores spread in the environment or by contaminated honey.

Bayheart then recalled all of its products nationwide on November 11 in connection with increasing cases of infant botulism.

As soon as he heard it was Bayheart, Mazziotti said he thought: “This can’t be a coincidence.”

Bayheart officials confirmed this week that laboratory tests of the previously discontinued formula found that some samples were contaminated with the type of bacteria that leads to infant botulism.

Marler said at least three other cases before this outbreak involved children who drank Bayheart wine and were treated for botulism, according to their families. One consumed Bayheart formula in December 2024. The other two became ill later in the spring, he said.

An official with the US Centers for Disease Control and Prevention said federal investigators were aware of earlier reports of the illnesses, but efforts are now focused on understanding the unusual surge of dozens of infections recorded after August 1.

“That doesn’t mean they’re not necessarily part of it,” said Dr. Jennifer Cope, the CDC scientist who led the investigation. “That’s it right now, we’re focused on this big growth.”

Because so much time has passed and because parents of infants who previously became ill may not have recorded product lots or kept empty cans of formula, “it will certainly be difficult to link them back,” Cope said.

Connolly said it felt as if her daughter had been forgotten.

“I want to know why the cases that started in August were investigated, but why the cases that started in March were not investigated?” Connolly said.

Cope and other health officials said the strong signals linking Bayheart to infant botulism cases have only become apparent in recent weeks.

California health officials said that before this outbreak, no powdered infant formula in the U.S. had tested positive for the type of bacteria that causes botulism. The number of cases was also within the expected limits. Testing of an open can of formula fed to a sick baby in the spring did not detect the bacteria.

Then, starting in August and continuing through October, more cases were identified. east coast Officials said it involved a type of venom rarely found in the area. More cases were seen in very young infants and more cases were linked to Bayheart formula, which makes up less than 1 percent of infant formula sold in the US.

Earlier this month, after a sample from a can of Bayheart formula fed to a sick infant tested positive for the illness-causing germ, officials notified the CDC, the U.S. Food and Drug Administration and the public.

Less than 200 cases of infant botulism are reported each year in the United States. The disease occurs when children swallow spores that germinate in the intestine and produce a toxin. The bacteria that cause disease are ubiquitous in the environment, including soil and water, so the source is often unknown.

Officials with the California Infant Botulism Treatment and Prevention Program track reports of botulism and distribute the disease’s only treatment, an IV drug called BabyBIG.

Outside food safety experts said the CDC should count earlier cases as part of the outbreak if the infants consumed Bayheart formula and were treated for botulism.

“Absolutely, yes, they should be included,” said Frank Yiannas, former deputy commissioner for food policy and response at the U.S. Food and Drug Administration. “Why wouldn’t they be included?”

Sandra Askin, chief executive of STOP Foodborne Illness, an advocacy group, agreed.

“This outbreak is traumatic for parents,” she said. “They may have fed their newborns and infants a product they thought was safe. And now they’re dealing with hospitalizations and serious illness in their children.”

Connolly and Mazziotti said their children are improving, although they still have some lingering effects. Botulism causes symptoms that include constipation, poor feeding, weakness of the head and limbs, and other problems.

After months of uncertainty about the possible cause of the infection, Connolly said she had “become completely obsessed” with the link to the Bayheart formula. Now, she just wants answers.

“We deserve to know the data that can help us understand how our children got sick,” he said.

,

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education and the Robert Wood Johnson Foundation. AP is solely responsible for all content.

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