ByHeart baby formula recalled amid infant botulism investigation
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James Powel, USA TODAY November 10, 2025 at 2:46 AM
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ByHeart, a next-generation baby nutrition company, has announced a voluntary recall of some batches of its powdered infant formula after federal authorities linked the product to an infant botulism outbreak.
In separate statements on Nov. 8, the U.S. Food and Drug Administration and the Centers for Disease Control and Prevention said two lots of ByHeart Whole Nutrition Infant Formula were recalled. The CDC said 13 cases of infant botulism across 10 states were linked to the formula.
All the cases have resulted in hospitalizations, according to the CDC. No deaths were reported as of Nov. 9.
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The formula was distributed online and nationwide, according to the FDA. The recalled formula makes up less than 1% of all infant formula sold in the United States and does not raise shortage concerns, the agency said.
The CDC said the Infant Botulism Treatment and Prevention Program, part of the California Department of Public Health, is investigating the outbreak "linked to recalled infant formula." The state program, which developed and provides the only source of infant botulism treatment in the world, alerted the CDC of the possible outbreak, the California Department of Public Health said.
Testing of leftover formula is underway, the FDA said. Results are expected in the coming weeks.
ByHeart denied the link to its products in a statement posted to its website and said "no related toxins have been found in any ByHeart product."
"Still, we decided to take this step to remove any potential risk from the market and ensure that the safety and well-being of every baby who uses ByHeart — including our own — will always come first," the company added.
Here's what to know about the infant formula botulism recall.
What ByHeart products are being recalled?
Two lots of ByHeart's Whole Nutrition Infant Formula are being recalled:
Lot: 206VABP/251261P2 with a “use by" date of Dec. 1, 2026
Lot: 206VABP/251131P2 with a "use by" date of Dec. 1, 2026
The recalled lots were manufactured on April 23 and May 6, according to the company. The lots were primarily distributed in July and August.
ByHeart advised those with recalled cans of formula to dispose of the product immediately and offered to replace them at no cost.
Where are the cases of infant botulism?
Federal officials announced that the cases of infant botulism linked to the recall occurred in:
Arizona
California
Illinois
Minnesota
New Jersey
Oregon
Pennsylvania
Rhode Island
Texas
Washington
California, Illinois, and Texas each saw two cases, according to the FDA's Nov. 8 announcement.
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=padding-bottom:56%>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.
" data-src=https://s.yimg.com/ny/api/res/1.2/OIaDuBQk1nrNxd_YCJjDlQ--/YXBwaWQ9aGlnaGxhbmRlcjt3PTEyNDI7aD04NTE-/https://media.zenfs.com/en/usa_today_slideshows_242/ea62e25c5245aae282619b85b061ab5e class=caas-img data-headline="See the 'risky foods' linked to recent US recalls and illness outbreaks" data-caption="
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.
">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.
" src=https://s.yimg.com/ny/api/res/1.2/OIaDuBQk1nrNxd_YCJjDlQ--/YXBwaWQ9aGlnaGxhbmRlcjt3PTEyNDI7aD04NTE-/https://media.zenfs.com/en/usa_today_slideshows_242/ea62e25c5245aae282619b85b061ab5e class=caas-img>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=padding-bottom:56%>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.
" data-src=https://s.yimg.com/ny/api/res/1.2/Pse0WA8WALsote64upvrcw--/YXBwaWQ9aGlnaGxhbmRlcjt3PTEyNDI7aD04Mjg-/https://media.zenfs.com/en/usa_today_slideshows_242/9bfcc95c51e289d051769955c9ad2c03 class=caas-img data-headline="See the 'risky foods' linked to recent US recalls and illness outbreaks" data-caption="
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.
">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.
" src=https://s.yimg.com/ny/api/res/1.2/Pse0WA8WALsote64upvrcw--/YXBwaWQ9aGlnaGxhbmRlcjt3PTEyNDI7aD04Mjg-/https://media.zenfs.com/en/usa_today_slideshows_242/9bfcc95c51e289d051769955c9ad2c03 class=caas-img>cucumbers recalled due to a salmonella outbreak that infected 113 people across 23 states, can become adulterated with E. coli through fecal contamination, which can occur through wastewater, water in the growing area, fertilizer and the proximity of the growing area to livestock.
" style=padding-bottom:56%>Produce, like the cucumbers recalled due to a salmonella outbreak that infected 113 people across 23 states, can become adulterated with E. coli through fecal contamination, which can occur through wastewater, water in the growing area, fertilizer and the proximity of the growing area to livestock.
" data-src=https://s.yimg.com/ny/api/res/1.2/O._5uEh50acHVuYWhyGlkg--/YXBwaWQ9aGlnaGxhbmRlcjt3PTEyNDI7aD04Mjg-/https://media.zenfs.com/en/usa_today_slideshows_242/f13472dedea06cffc47625696e01e3bf class=caas-img data-headline="See the 'risky foods' linked to recent US recalls and illness outbreaks" data-caption="
Produce, like the cucumbers recalled due to a salmonella outbreak that infected 113 people across 23 states, can become adulterated with E. coli through fecal contamination, which can occur through wastewater, water in the growing area, fertilizer and the proximity of the growing area to livestock.
">Produce, like the cucumbers recalled due to a salmonella outbreak that infected 113 people across 23 states, can become adulterated with E. coli through fecal contamination, which can occur through wastewater, water in the growing area, fertilizer and the proximity of the growing area to livestock.
" src=https://s.yimg.com/ny/api/res/1.2/O._5uEh50acHVuYWhyGlkg--/YXBwaWQ9aGlnaGxhbmRlcjt3PTEyNDI7aD04Mjg-/https://media.zenfs.com/en/usa_today_slideshows_242/f13472dedea06cffc47625696e01e3bf class=caas-img>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.
" data-src=https://s.yimg.com/ny/api/res/1.2/dbzc2mG5oqPJ8KwZGtE.HQ--/YXBwaWQ9aGlnaGxhbmRlcjt3PTEyNDI7aD04Mjg-/https://media.zenfs.com/en/usa_today_slideshows_242/c33fdf952701e2d3b07e54b9d53b65dd class=caas-img data-headline="See the 'risky foods' linked to recent US recalls and illness outbreaks" data-caption="
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.
">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.
" src=https://s.yimg.com/ny/api/res/1.2/dbzc2mG5oqPJ8KwZGtE.HQ--/YXBwaWQ9aGlnaGxhbmRlcjt3PTEyNDI7aD04Mjg-/https://media.zenfs.com/en/usa_today_slideshows_242/c33fdf952701e2d3b07e54b9d53b65dd class=caas-img>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=padding-bottom:56%>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.
" data-src=https://s.yimg.com/ny/api/res/1.2/IMBEVbqmJKn.hFWVXkgVMw--/YXBwaWQ9aGlnaGxhbmRlcjt3PTEyNDI7aD04Mjg-/https://media.zenfs.com/en/usa_today_slideshows_242/83ecd4edb909f0cbaecd8d647d00d067 class=caas-img data-headline="See the 'risky foods' linked to recent US recalls and illness outbreaks" data-caption="
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.
">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.
" src=https://s.yimg.com/ny/api/res/1.2/IMBEVbqmJKn.hFWVXkgVMw--/YXBwaWQ9aGlnaGxhbmRlcjt3PTEyNDI7aD04Mjg-/https://media.zenfs.com/en/usa_today_slideshows_242/83ecd4edb909f0cbaecd8d647d00d067 class=caas-img>Eggs can become contaminated via the same means as cucumbers and other raw produce, especially if they have a cracked shell.
" data-src=https://s.yimg.com/ny/api/res/1.2/pu1HEbUS9ofL55HdiAr2wQ--/YXBwaWQ9aGlnaGxhbmRlcjt3PTEyNDI7aD04Mjg-/https://media.zenfs.com/en/usa_today_slideshows_242/f79fcd18fa33c0675d8b2078d0bdbeb6 class=caas-img data-headline="See the 'risky foods' linked to recent US recalls and illness outbreaks" data-caption="
Eggs can become contaminated via the same means as cucumbers and other raw produce, especially if they have a cracked shell.
">Eggs can become contaminated via the same means as cucumbers and other raw produce, especially if they have a cracked shell.
" src=https://s.yimg.com/ny/api/res/1.2/pu1HEbUS9ofL55HdiAr2wQ--/YXBwaWQ9aGlnaGxhbmRlcjt3PTEyNDI7aD04Mjg-/https://media.zenfs.com/en/usa_today_slideshows_242/f79fcd18fa33c0675d8b2078d0bdbeb6 class=caas-img>McDonald's Quarter Pounders triggered some locations to stop serving the burger temporarily.
" style=padding-bottom:56%>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.
" data-src=https://s.yimg.com/ny/api/res/1.2/EiiAnsMZpPgnzw_QD2dFAA--/YXBwaWQ9aGlnaGxhbmRlcjt3PTEyNDI7aD04MjI-/https://media.zenfs.com/en/usa_today_slideshows_242/a375b05e367252f33d058cebdc891644 class=caas-img data-headline="See the 'risky foods' linked to recent US recalls and illness outbreaks" data-caption="
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.
">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.
" src=https://s.yimg.com/ny/api/res/1.2/EiiAnsMZpPgnzw_QD2dFAA--/YXBwaWQ9aGlnaGxhbmRlcjt3PTEyNDI7aD04MjI-/https://media.zenfs.com/en/usa_today_slideshows_242/a375b05e367252f33d058cebdc891644 class=caas-img>Solata Foods spinach recall in 2024.
" style=padding-bottom:56%>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.
" data-src=https://s.yimg.com/ny/api/res/1.2/DVDkWPfQr9FG_29NIGPcrw--/YXBwaWQ9aGlnaGxhbmRlcjt3PTEyNDI7aD04Mjg-/https://media.zenfs.com/en/usa_today_slideshows_242/a75cb0fb08b030fe9352c293072ef802 class=caas-img data-headline="See the 'risky foods' linked to recent US recalls and illness outbreaks" data-caption="
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.
">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.
" src=https://s.yimg.com/ny/api/res/1.2/DVDkWPfQr9FG_29NIGPcrw--/YXBwaWQ9aGlnaGxhbmRlcjt3PTEyNDI7aD04Mjg-/https://media.zenfs.com/en/usa_today_slideshows_242/a75cb0fb08b030fe9352c293072ef802 class=caas-img>major E. coli outbreak in late 2024, leaving at least 39 ill and one dead.
" style=padding-bottom:56%>Organic carrots were linked to a major E. coli outbreak in late 2024, leaving at least 39 ill and one dead.
" data-src=https://s.yimg.com/ny/api/res/1.2/yPhlEWaQOjK0vqaHjj4XMw--/YXBwaWQ9aGlnaGxhbmRlcjt3PTEyNDI7aD04Mjg-/https://media.zenfs.com/en/usa_today_slideshows_242/155d1bb268cb1031536f42b68cc575d7 class=caas-img data-headline="See the 'risky foods' linked to recent US recalls and illness outbreaks" data-caption="
Organic carrots were linked to a major E. coli outbreak in late 2024, leaving at least 39 ill and one dead.
">Organic carrots were linked to a major E. coli outbreak in late 2024, leaving at least 39 ill and one dead.
" src=https://s.yimg.com/ny/api/res/1.2/yPhlEWaQOjK0vqaHjj4XMw--/YXBwaWQ9aGlnaGxhbmRlcjt3PTEyNDI7aD04Mjg-/https://media.zenfs.com/en/usa_today_slideshows_242/155d1bb268cb1031536f42b68cc575d7 class=caas-img>millions of pounds of RTE foods were recalled by BrucePac for listeria contamination.
" style=padding-bottom:56%>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.
" data-src=https://s.yimg.com/ny/api/res/1.2/.QE9kd8WKUQOlA17jrDojw--/YXBwaWQ9aGlnaGxhbmRlcjt3PTEyNDI7aD05MzI-/https://media.zenfs.com/en/usa_today_slideshows_242/a819b16c2046400d4daad3c994cd1d67 class=caas-img data-headline="See the 'risky foods' linked to recent US recalls and illness outbreaks" data-caption="
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.
">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.
" src=https://s.yimg.com/ny/api/res/1.2/.QE9kd8WKUQOlA17jrDojw--/YXBwaWQ9aGlnaGxhbmRlcjt3PTEyNDI7aD05MzI-/https://media.zenfs.com/en/usa_today_slideshows_242/a819b16c2046400d4daad3c994cd1d67 class=caas-img>
1 / 10See the 'risky foods' linked to recent US recalls and illness outbreaks
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.
What are the symptoms of infant botulism?
Most infants with infant botulism will initially develop constipation, poor feeding, loss of head control, and difficulty swallowing, according to the CDC. If left untreated, infants may experience a progressive, flaccid paralysis that can lead to breathing difficulties and require weeks of hospitalization.
According to the Cleveland Clinic, infant botulism symptoms include:
Choking when trying to feed.
Constipation.
Weaker suck or poor feeding.
Eyelid drooping.
Lack of facial expressions, being unable to lift their head, or other signs of muscle weakness or paralysis.
Weaker crying.
Weakness or decreased muscle tone, especially starting at the top of their body and limbs, making your baby feel "floppy" and keeping them from reaching or grabbing.
Bowel movement changes, like not pooping for days or even weeks at a time.
This article originally appeared on USA TODAY: States see infant botulism cases amid ByHeart baby formula probe
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