No known outbreaks of infant botulism tied to powdered formula have previously been confirmed, said Dr. Steven Abrams, a University of Texas nutrition expert.

“This would be extremely rare,” he said.

Infant botulism treatment

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.

BabyBIG works to shorten hospital stays and decrease the severity of illness in babies with botulism. Because the infection can affect the ability to breathe, infants often need to be placed on ventilators.

All of the children in the ByHeart outbreak have received the medication, the CDC said.

Potential impact on U.S. formula supplies

There is no danger of infant formula shortages because of this outbreak. ByHeart, which was founded in 2016, accounts for an estimated 1% of national formula sales, according to the CDC. The company sells formula through its website and in retail stores nationwide.

That’s different from the crisis 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 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 massive nationwide shortage that lasted for months.

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

Reviewing infant formula ingredients

Federal health officials have vowed to overhaul the U.S. food supply and are taking a new look at infant formula.

Health Secretary Robert F. Kennedy Jr. has directed the Food and Drug Administration to review the nutrients and other ingredients in infant formula, which fills the bottles of millions of American babies.

The effort, dubbed “Operation Stork Speed,” is the first deep look at the ingredients since 1998.

FDA officials are reviewing comments from industry, health experts and public to decide next steps.

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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. The AP is solely responsible for all content.

Jonel Aleccia, The Associated Press