Baby formula recalled over possible infant botulism outbreak

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ByHeart has recalled some batches of its powdered infant formula related to an infant botulism outbreak. (Photo courtesy of the Food and Drug Administration)

ByHeart, a baby nutrition company, announced a voluntary recall of some batches of its powdered infant formula after the product was tied to an infant botulism outbreak.

The Food and Drug Administration in a Nov. 8 recall letter said two lots of ByHeart Whole Nutrition Infant Formula were recalled and noted that 13 cases of infant botulism across 10 states were connected to the formula.

According to the agency, the botulism cases have resulted in hospitalizations and no deaths have been reported.

Which ByHeart formula products were recalled?

Why you should care:

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")

These recalled items were distributed online and nationwide, and account for less than 1% of all infant formula sold in the U.S. and do not heighten shortage concerns, the FDA noted. 

Botulism cases investigated in multiple states

Why you should care:

The Food and Drug Administration, the Centers for Disease Control and Prevention (CDC) and several state and local agencies are investigating a multiple state outbreak of 13 infant botulism illnesses in 10 states listed below:

• Arizona
• California
• Illinois
• Minnesota
• New Jersey
• Oregon
• Pennsylvania
• Rhode Island
• Texas
• Washington

According to the FDA, 13 cases included in this outbreak are reported to have consumed ByHeart- brand powdered infant formula. And state officials have collected the remaining infant formula for testing. 

ByHeart statement

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." 

What if I have the recalled formula?

What you can do:

Parents with the ByHeart Whole Nutrition Infant Formula should throw this product away immediately.

The Food and Drug Administration says that if your child has symptoms after eating the formula, and it's still in your home, write down the information on the bottom of the container before discarding it.

What are the symptoms of infant botulism?  

Dig deeper:

According to the Food and Drug Administration, infants with botulism develop constipation, poor feeding, loss of head control, and difficulty swallowing, and this can lead to difficulty breathing and respiratory issues. Symptoms of infant botulism can take as long as several weeks to develop after formula ingestion.