ByHeart recalls all of its baby formula in the US amid infant botulism outbreak investigation

By Jacqueline Howard, CNN

(CNN) — The baby formula company ByHeart said Tuesday that it has recalled all of its infant formula products nationwide, including cans and single-serve sticks.

The US Food and Drug Administration and the US Centers for Disease Control and Prevention are investigating a multistate outbreak of infant botulism that may be tied to ByHeart’s “whole nutrition” infant formula products.

Epidemiologic and laboratory data has shown that ByHeart Whole Nutrition infant formula might be contaminated with Clostridium botulinum, the germ that causes botulism, the FDA said Tuesday.

According to the FDA, as of Monday, 15 children with suspected or confirmed infant botulism who had also been exposed to ByHeart infant formula have been reported in 12 states: Arizona, California, Illinois, Kentucky, Minnesota, North Carolina, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas and Washington.

All 15 infants, who ranged in age from 16 days to 157 days, were hospitalized and given BabyBIG, an intravenous antibody treatment for infant botulism. No deaths have been reported.

Infant botulism happens when a baby swallows Clostridium botulinum spores, which can grow in the gut and produce botulinum neurotoxin, according to the CDC. Signs and symptoms – which can take several weeks to develop – may include constipation, poor feeding, loss of head control, difficulty swallowing and a weak and altered cry, which can progress to difficulty breathing and respiratory arrest.

Since August, 84 infants have received treatment for infant botulism nationwide, based on data from the California Department of Public Health’s Infant Botulism Treatment and Prevention Program, according to the FDA. Among those infants, 43% had been exposed to powdered infant formula. And among those who had powdered infant formula exposure, more than 40% consumed ByHeart Whole Nutrition formula.

“This information shows that ByHeart brand formula is disproportionately represented among sick infants in this outbreak, especially given that ByHeart represents an estimated 1% of all infant formula sales in the United States,” according to the FDA. “Investigations remain ongoing but have not identified any other infant formula brands or shared exposures that pose a risk to infants.”

‘All ByHeart product must be discarded’

Mia Funt and Ron Belldegrun, the co-founders of ByHeart, said in an online letter Tuesday that they have provided the FDA with access to all of their facilities and products.

“Upon learning about this outbreak on Friday evening, we immediately began conducting our own extensive testing on all ByHeart batches. Additionally, we are providing the FDA complete and unrestricted access to all of our facilities and products for their investigation, which has been done regularly at our owned facilities. We will share the results of our own testing as they become available,” Funt and Belldegrun wrote.

“At this moment, the most important thing for you to know is that all ByHeart product must be discarded. We know that switching formulas is not an easy process or decision. We have resources to help,” they said, providing a link to a guide on how to switch infant formulas. “We are so sorry, and are committed to doing anything we can to support you.”

Several states are testing leftover formula, the FDA said, and the results are expected in the coming weeks.

Preliminary lab results that the California Department of Public Health released Saturday suggested that the bacterium that causes botulism was present in an open can of ByHeart infant formula, which was fed to an infant with botulism.

“Infant botulism is a very rare disease that occurs when babies inhale or swallow spores of the toxin-producing bacteria that cause infant botulism, which leads to progressive muscle weakness including trouble breathing if not treated in time,” Dr. Erica Pan, California Department of Public Health’s director and state public health officer, said in a news release Saturday.

“We have tested a sample of the specific powdered infant formula linked with these cases and preliminary tests are positive,” Pan said. “We are urging parents to stop using ByHeart formula immediately.”​

The FDA said no unopened ByHeart product has tested positive for Clostridium botulinum spores or toxin.

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