ByHeart recalls all baby formula amid botulism outbreak

ByHeart announced Tuesday it is recalling all of its baby formula amid a multistate outbreak of infant botulism, and federal health officials said parents and caregivers should stop feeding its products to children immediately.

This marks a significant expansion of the organic baby formula company’s recall of two batches this weekend after health agencies said they are investigating botulism hospitalizations potentially linked to ByHeart formula.

Federal officials have reported 15 hospitalizations in a dozen states. No deaths have been reported.

The company said it sells more than 200,000 cans of its ByHeart Whole Nutrition Infant Formula per month, in addition to its Anywhere Pack travel pouch. The Food and Drug Administration has said the outbreak “does not create shortage concerns,” estimating that ByHeart Whole Nutrition Infant Formula accounts for less than 1% of all formula sold in the United States. The country did experience a formula shortage in 2022 after the temporary closure of an Abbott Nutrition plant over concerns about bacterial infections in several children left parents scrambling to find replacements for the popular infant formula. A definitive link between contamination in the facility and the infections was not found, health officials have said.

ByHeart officials said they were recalling their products out of caution, not because they were proved to be contaminated. It markets its formula as made with organic grass-fed whole milk and a protein blend closer to breast milk than its competitors’ versions.

“This nationwide recall reflects our commitment to protecting babies and giving families clear, actionable information,” Mia Funt, co-founder and president of ByHeart, said in a news release. She added that the company is conducting its own investigation, including testing all batches of formula with an independent third-party laboratory.

Infant botulism occurs after babies swallow spores from a type of bacteria known as Clostridium botulinum, which can make toxins in a baby’s large intestine. The illness is rare but potentially fatal. Most babies will initially develop constipation, loss of head control and difficulty swallowing. That can progress to difficulty breathing and respiratory arrest. Symptoms can take up to several weeks to develop after the formula is ingested.

All 15 infants — ranging from about 2 weeks to 5 months old — have been hospitalized and treated with intravenous medication since mid-August, federal officials said. Laboratory confirmation for some cases is ongoing, and all reported consuming ByHeart-branded powdered infant formula at some point, according to the FDA. The initial batch of illnesses was reported in Arizona, California, Illinois, Kentucky, Minnesota, North Carolina, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas and Washington.

In an update Tuesday, the FDA said it has not identified any other infant brands or shared exposures that could pose a risk to infants.

The California Department of Public Health alerted the Centers for Disease Control and Prevention of an outbreak of infant botulism possibly tied to ByHeart’s products. The state health department tested a can of powdered infant formula given to a baby with infant botulism, California officials said Saturday, and the preliminary results suggested the presence of the bacteria. Several states have collected leftover infant formula for testing, and results are expected in the coming weeks, according to federal health agencies.

ByHeart said Saturday that the FDA has not identified a direct link between any formula and the cases, citing a broader increase in the illness. The company has called for testing on unopened cans of its recalled product at its facility.

Devon Kuehn, ByHeart’s chief medical officer, said FDA inspectors were at the company’s Portland, Oregon, plant on Monday. The company produces its formula powder at a plant in Iowa and ships it to Portland for packing.

ByHeart recalled several batches of formula in late 2022 after a different bacterium was detected. In 2023, the FDA sent the company a warning letter detailing safety violations at the contracted manufacturing facility that led up to the recall and corrective action the company needed to take. ByHeart said it stopped using that manufacturer and purchased two new manufacturing facilities.