Baby formula recall linked to infant botulism outbreak is expanding: What to know

ByHeart, which makes organic infant formula, has recalled all of its products sold throughout the U.S. amid a growing outbreak of infant botulism. 

Botulism is a rare but serious disease that can cause paralysis and death. 

ByHeart baby formula recall linked to botulism

By the numbers:

California health officials said the outbreak, which is tied to ByHeart formula and started in August, has now sickened at least 15 infants in 12 states. 

That's an increase from 13 cases in 10 states reported Saturday.  No deaths have been reported.

Illnesses began between Aug. 9 and Nov. 10, federal officials said. Cases were reported in Arizona, California, Illinois, Kentucky, Minnesota, North Carolina, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas and Washington.

Investigators have not identified any other infant formula brands or other sources of exposure in the outbreak, officials said.

What they're saying:

ByHeart released a statement on its website on Nov. 9 explaining, "We are conducting testing, with a third party independent testing laboratory, of the two recalled batches of our formula using food safety testing best practices, to provide you results that we all can feel confident in." 

The company added, "From the very beginning, we have acted quickly and decisively to remove any potential risk— immediately voluntarily recalling the relevant batches of our formula that the FDA told us were consumed by infants in their investigation. We want to remind you to dispose of any cans with the recalled batch codes and to reach out to our Parent Experience team for support. They can help you replace your formula at no cost." 

Which ByHeart formula products were recalled?

What you can do:

ByHeart officials say parents and caregivers who have the formula in their homes should stop using it immediately and dispose of the product. 

The Food and Drug Administration said that certain lots of ByHeart Whole Nutrition Infant Formula were recalled and listed below:

• Lot: 206VABP/251261P2 ("Use by 01 Dec 2026")
• Lot: 206VABP/251131P2 ("Use by 01 Dec 2026")

ByHeart recall backstory

The backstory:

The outbreak has sickened babies aged 2 weeks to 5 months since it started. 

The infants were hospitalized after consuming ByHeart powdered formula, according to the U.S. Centers for Disease Control and Prevention.

California officials confirmed that a sample from an open can of ByHeart baby formula fed to an infant who fell ill contained the type of bacteria that causes the toxin linked to the outbreak. The tests to confirm contamination involve injecting mice with the cultured bacterium and then waiting up to four days to see if they get sick, said Dr. Erica Pan, the state health officer.

"These mice got sick really quickly," Pan said in an interview.

ByHeart officials said they recalled their products "in close collaboration" with the U.S. Food and Drug Administration, despite the fact that no previously unopened product tested positive for the illness-causing bacteria. The type of bacteria that produces the toxin is widespread in the environment and could come from sources other than the formula, company officials said.

The FDA is investigating 84 cases of infant botulism detected since August. Of those, 15 consumed ByHeart formula, the agency said in a statement.

What is botulism?

Big picture view:

Botulism is a rare but serious disease that can cause paralysis and death. Symptoms can take weeks to develop.

Infant botulism typically affects fewer than 200 babies in the U.S. each year. It is caused by a type of bacteria that produces a toxin in the large intestine. The bacterium is spread through hardy spores present in the environment that can cause serious illness, including paralysis.

Infants are particularly vulnerable to infection because their gut microbiomes are not developed enough to prevent the spores from germinating and producing the toxin. They can be sickened after exposure to the spores in dust, dirt or water or by eating contaminated honey.

EARLIER: Baby formula recalled over possible infant botulism outbreak

Symptoms can take weeks to develop and can include poor feeding, loss of head control, drooping eyelids and a flat facial expression. Babies may feel "floppy" and can have problems swallowing or breathing.

The only treatment is known as BabyBIG, an IV medication made from the pooled blood plasma of adults immunized against botulism. California's Infant Botulism Treatment and Prevention Program developed the product and is the sole source worldwide.

All of the children in the ByHeart outbreak have received the medication, the CDC said. The treatment is delivered in vials that cost $69,300 apiece, Pan said.

Could ByHeart recall cause formula shortage?

Dig deeper:

According to experts, there is little danger of infant formula shortages because ByHeart represents a small share of the market. 

That's far different from the crises in late 2021 and 2022, when four infants were sickened by a different germ after consuming formula made by Abbott Nutrition. Two of the babies died. 

No direct link was found between the Abbott products and the infections caused by a different germ, cronobacter sakazakii, but FDA officials closed the company's Michigan plant after contamination and other problems were detected.

Abbott recalled top brands of infant formula, triggering a nationwide shortage that lasted months.

In 2022, ByHeart recalled five batches of infant formula after a sample at the company's packaging plant tested positive for cronobacter sakazakii. In 2023, the FDA sent a warning letter to the company detailing "areas that still require corrective actions."