An outbreak of infant botulism linked to recalled ByHeart baby formula has broadened as federal health officials say the company's products may have been contaminated since they were released in March 2022.
As of Dec. 10, the total outbreak now includes at least 51 infants with suspected or confirmed botulism across 19 states that were exposed to ByHeart Whole Nutrition infant formula, according to theU.S. Food and Drug Administration. Health officials previously reported thatthe outbreakincluded 39 suspected or confirmed cases in 18 states since August of this year.
But as the FDA, along with theCenters for Disease Control and Preventionand other state and local health agencies, continued their investigation into the outbreak, the CDC said it has expanded its case definition to include "any infant with botulism who was exposed to ByHeart formula at any time since the product's release."
Consumer Reports, the nonprofit known for testing and monitoring consumer-facing policy and products, released its annual risky food report in April, naming the 10 foods of 2024 that were subject to the most recalls and/or associated with the largest illness outbreaks. USA TODAY broke it down further on a what-you-need-to-know basis. " style="max-width:100%; height:auto; border-radius:6px; margin:10px 0;" loading="lazy" /> 
Deli meat is somewhat of a "risky" food as it is often associated with the spread of listeria, such as in the 2024 case of the Boar's Head listeria outbreak that killed 10. Listeria monocytogenes is a hardy germ that can survive in very low temperatures but thrives in cool and damp places. It can, and will, happily live on foods in your or your grocery store's storage area, and the process for mass-producing the meat lends itself to plenty of opportunities for contamination." style="max-width:100%; height:auto; border-radius:6px; margin:10px 0;" loading="lazy" /> 
Produce, like the cucumbers recalled due to a salmonella outbreak that infected 113 people across 23 states, can become adulterated with harmful bacteria through fecal contamination, which can occur through wastewater, water in the growing area, fertilizer and the proximity of the growing area to livestock." style="max-width:100%; height:auto; border-radius:6px; margin:10px 0;" loading="lazy" /> 
Raw dairy, which is always unsafe to consume and illegal to sell in some states, poses a risk when it's not pasteurized. Dairy pasteurization, or heating milk products to a high enough temperature to kill harmful bacteria, has been practiced since the 1920s and has resulted in illnesses commonly spread via milk, such as listeriosis, diphtheria and tuberculosis, becoming less prevalent." style="max-width:100%; height:auto; border-radius:6px; margin:10px 0;" loading="lazy" /> 
Cotija and queso fresco cheese are made from unpasteurized milk, meaning they carry an increased risk. One producer, Rizo-Lopez Foods, was shut down in October 2024 after its cheeses were linked to a years-long listeria outbreak that killed two people and made dozens of others sick." style="max-width:100%; height:auto; border-radius:6px; margin:10px 0;" loading="lazy" /> 
Eggs can become contaminated via the same means as cucumbers and other raw produce, especially if they have a cracked shell. " style="max-width:100%; height:auto; border-radius:6px; margin:10px 0;" loading="lazy" /> 
Like other raw produce, onions can become infected via fecal contamination. In 2024, E. coli-contaminated slivered onions on McDonald's Quarter Pounders triggered some locations to stop serving the burger temporarily. " style="max-width:100%; height:auto; border-radius:6px; margin:10px 0;" loading="lazy" /> 
Like cucumbers and onions, leafy greens are easily contaminated with bacteria like E. coli, as in the case of the Solata Foods spinach recall in 2024. " style="max-width:100%; height:auto; border-radius:6px; margin:10px 0;" loading="lazy" /> 
Organic carrots were linked to a major E. coli outbreak in late 2024, leaving at least 39 ill and one dead. " style="max-width:100%; height:auto; border-radius:6px; margin:10px 0;" loading="lazy" /> 
Ready-to-eat/cooked poultry and meat have been the source of multiple major recalls and foodborne illness outbreaks in recent years. The same issue arises with RTE foods as with deli meat; the conditions they are made and stored under are often ideal for bacteria such as listeria to grow. In 2024, millions of pounds of RTE foods were recalled by BrucePac for listeria contamination. " style="max-width:100%; height:auto; border-radius:6px; margin:10px 0;" loading="lazy" /> See the 'risky foods' linked to US recalls and illness outbreaks
Consumer Reports, the nonprofit known for testing and monitoring consumer-facing policy and products, releasedits annual risky food reportin April, naming the 10 foods of 2024 that were subject to the most recalls and/or associated with the largest illness outbreaks. USA TODAYbroke it down furtheron a what-you-need-to-know basis.
Epidemiologic and laboratory data showed that ByHeart baby formula may have been tainted withClostridium botulinum, a bacterium that produces a neurotoxin that causes botulism, according to the FDA.
"ByHeart's and FDA's investigations into the root cause of the outbreak are ongoing, and at this time, FDA cannot rule out the possibility that contamination might have affected all ByHeart formula products," the agency said.
With the broadened definition, the CDC said it has identified 10 additional cases that occurred from December 2023 to July 2025. The FDA noted that no cases have been identified from March 2022 through December 2023.
ByHeart, a next-generation baby nutrition company based in New York,announced a voluntary recallof some batches of its powdered infant formula on Nov. 8 after health officials tied the product to an infant botulism outbreak. Days later, the companyexpanded its recallto include all batches of ByHeart Whole Nutrition Infant Formula cans and "Anywhere Pack" sticks nationwide.
Signs to look for:Foodborne botulism is a rare, life-threatening condition.
At least 51 cases tied to ByHeart baby formula
The baby formula was distributed online and in stores nationwide and internationally, according to the FDA.
At least 51 infants who became ill were hospitalized, but no deaths have been reported as of Dec. 10, the agency said. The infants ranged in age from 16 to 264 days.
The FDA said laboratory confirmation for some cases remains ongoing and that the most recent illness was reported on Dec. 1. States with suspected or confirmed cases include Arizona, California, Idaho, Illinois, Kentucky, Massachusetts, Maine, Michigan, Minnesota, North Carolina, New Jersey, Ohio, Oregon, Pennsylvania, Rhode Island, Texas, Virginia, Washington, and Wisconsin.
"State and local public health officials are interviewing caregivers about the foods the infants were fed in the month before they got sick," the FDA said. "Fifty-one infants have been identified that were fed ByHeart Whole Nutrition powdered infant formula before getting sick."
Since Nov. 26, the FDA said it has not received reports of recalled baby formula being found in stores. Ina statement on Nov. 24, ByHeart said testing by an independent laboratory showed that five of 36 samples from three different lots contained Clostridium botulinum.
"Based on these results, we cannot rule out the risk that all ByHeart formula across all product lots may have been contaminated," the company said in the statement.
'Absolutely terrifying':ByHeart sued over recalled formula by parents of infants sickened with botulism
ByHeart sued over recalled formula
Families of babies sickened with botulism have sued ByHeart. USA TODAYreported in Novemberthat two families in Arizona and Kentucky filed complaints in federal courts against ByHeart after their babies contracted the rare and potentially deadly disease.
Both families alleged that ByHeart is directly responsible for their infant children being sickened with botulism.
Infant botulism is a "rare but serious illness" that affects babies under 1 year old, according to the Cleveland Clinic, a nonprofit academic medical center.
Parents and guardians who see symptoms in an infant should seek immediate medical care, according to the CDC. Symptoms include poor feeding, loss of head control, difficulty swallowing, and decreased facial expression.
Health officials have advised parents and guardians who have recently fed their infant the recalled formula to remain vigilant, as botulism symptoms can take multiple weeks to develop.
Contributing: Jonathan Limehouse and Caroline C. Boyle, USA TODAY
This article originally appeared on USA TODAY:Infant botulism outbreak expands to all ByHeart products
