Infant Botulism Outbreak Expands With More Than 50 Babies Affected

Cases of the illness have been recorded in 19 states.

A person holds a container of ByHeart baby formula, which was recently recalled by the company, in Flagstaff, Ariz., on Nov. 12, 2025. Cheyanne Mumphrey/AP Photo

An outbreak of infant botulism tied to baby formula has expanded to include 51 infants across 19 states, federal officials said on Dec. 11.

The increase was partly driven by officials starting to look at reported cases dating back to late 2023 for infants who consumed formula from ByHeart Whole Nutrition, the Food and Drug Administration and the Centers for Disease Control and Prevention said.

The FDA “cannot rule out the possibility that contamination might have affected all ByHeart formula products,” officials said. “In response, CDC broadened the case definition to include any infant with botulism who was exposed to ByHeart formula at any time since the product’s release in March 2022.”

Officials identified 10 confirmed cases of botulism between December 2023 and July that meet the new case definition. They found none between March 2022 and December 2023.

Further recent cases have also been added to the total, including at least one case that started on Dec. 1.

Botulism occurs when a baby swallows spores from Clostridium botulinum, a bacterium. Samples of the ByHeart formula have tested positive for Clostridium botulinum.

Symptoms of botulism include difficulty swallowing and a lack of head control. All 51 infants with botulism were hospitalized. No infants have died as of yet.

The states reporting cases are Arizona, California, Idaho, Illinois, Kentucky, Massachusetts, Maine, Michigan, Minnesota, North Carolina, New Jersey, Ohio, Oregon, Pennsylvania, Rhode Island, Texas, Virginia, Washington, and Wisconsin.

Ohio is the new state reporting at least one case. The Ohio Department of Health has not released information on the matter.

Virginia was added to the list earlier in the month, when officials said that the outbreak included 39 suspected or confirmed cases of botulism since August across 18 states.

The infant in Virginia began having symptoms on Nov. 12, a spokesperson for the Virginia Department of Health told The Epoch Times in an email.

People with the ByHeart formula are being told not to use it. They are encouraged to keep it in a safe place in case their infant develops symptoms of botulism. If no symptoms develop after one month, they should throw the formula away, the CDC says.

If symptoms do develop, medical care should be sought immediately.

ByHeart recalled all infant formula in November. The company says on its website that it is offering refunds for all products purchased through its website on or after Aug. 1.

“We want to express how sorry we are for the anxiety and fear you’ve been facing, and as we navigate this moment, we are committed to doing it with as much heart, transparency, and integrity as possible,” the company’s founders said in a Nov. 24 statement to parents.

Officials had been saying that the ByHeart formula was still being found in some stores despite the recall. In the latest update, officials said that they have not received any of those reports since Nov. 26.

The ByHeart infant formula recall also affects markets outside the United States, according to the FDA.

The agency said customer data provided by Amazon shows that a small quantity of recalled ByHeart infant formula was distributed to Argentina, Brazil, Brunei, Canada, Chile, China, Colombia, Ecuador, Egypt, Hong Kong, Israel, Jamaica, Japan, Republic of Korea, Peru, Philippines, Romania, Singapore, South Africa, Thailand, and the British Virgin Islands.

“Consumers worldwide should not use any ByHeart brand infant formula as all ByHeart products are included in this recall,” the FDA said.

Greece’s National Organization for Medicines (EOF) on Dec. 8 warned consumers not to use the ByHeart formula.

“EOF calls on consumers not to purchase and use this specific product of any batch and, if they come into possession of the products, not to use them and to immediately inform EOF,” the agency said. “These products may be promoted in Greece via the internet.”