Botulism cases in infants rise to 31 amid ongoing recall of ByHeart baby formula, FDA says

Cases of botulism tied to ByHeart baby formula have doubled since the company expanded its recall of the products early this month, according to the U.S. Food and Drug Administration. 

There are now at least 31 reported cases of infant botulism associated with various lots of the ByHeart Whole Nutrition infant formula, the FDA said Wednesday. The infants were hospitalized across 15 states since Aug. 9, with the most recent case reported on Nov. 13, but no deaths have been reported.

Symptoms of infant botulism can take weeks to develop and can include poor feeding, loss of head control, drooping eyelids and a flat facial expression, the Centers for Disease Control and Prevention says. Babies may feel “floppy” and can have problems swallowing or breathing.

Despite the expanded recall of all ByHeart infant formula products, the FDA said it received multiple reports that the baby formula is still being found on store shelves in multiple states. 

The FDA’s update also said the recalled products have been sold online and shipped outside the U.S., cautioning consumers to not use any of the ByHeart brand products.

“We are doing everything we can to show up for parents,” ByHeart said in a statement on Nov. 13. “Please know that we are actively working on updates, and we will keep sharing information as quickly and clearly as we can.”

The parents of at least two babies sickened in the infantile botulism outbreak last week said they are suing the makers of the ByHeart baby formula. The lawsuits, filed in federal courts in two states, allege that the ByHeart formula the babies consumed was defective and the company was negligent in selling it. They seek financial payment for medical bills, emotional distress and other harm.

“It was just absolutely terrifying,” Hanna Everett told CBS News in an interview. “You know, we just kind of felt like we failed as a parent in some ways.”

ByHeart officials had said they would “address any legal claims in due course.”

“We remain focused on ensuring that families using ByHeart products are aware of the recall and have factual information about steps they should take,” the company had said in a statement. In a separate statement provided to CBS News last week, the company said, “We express our deepest sympathy to the families currently impacted by the cases of infant botulism.”

Infant botulism is caused by a type of bacterium 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, the CDC says. 

The FDA said health officials in several states have collected leftover infant formula for testing. As part of the agency’s investigation, officials are also testing samples of unopened product.

“Detection of Clostridium botulinum in infant formula is difficult, and a negative test result does not rule out the presence of the bacteria in the product,” the FDA said, adding that results are expected in the coming weeks.