ByHeart recalls all baby formula sold nationwide as infant botulism outbreak grows
ByHeart, a maker of organic infant formula, recalled all of its products sold nationwide on Tuesday, days after some batches were recalled amid a growing outbreak of infant botulism.
At least 15 babies in 12 states have been sickened in the outbreak since August, and more cases are on the way, according to state and federal health officials. All of the infants were hospitalized after consuming the ByHeart formula, officials said. No deaths have been reported.
ByHeart officials have extended the voluntary recall of two batches announced Saturday to all products present in consumers’ homes and in stores. This includes ByHeart Whole Nutrition and Anywhere Pack powdered formula packets. The company sells about 200,000 boxes of infant formula per month online and in stores such as Target, Walmart, Albertsons and Whole Foods, according to Dr. Devon Kuehn, chief medical officer.
Parents and guardians who have the formula at home “should immediately stop using it and dispose of the product,” Kuehn said.
Company officials said they conducted the unusual recall “in close collaboration” with the U.S. Food and Drug Administration “despite the fact that no unopened ByHeart products have tested positive” for contamination.
California health officials earlier confirmed that a sample from an opened box of ByHeart baby formula given to an infant who fell ill contained the type of bacteria that caused the toxin linked to the outbreak.
“This action underscores ByHeart’s core mission: protecting babies first,” the company said in a statement.
The U.S. Food and Drug Administration is investigating 84 cases of infant botulism detected since August. Of those, 36 consumed formula, and more than a third received ByHeart formula, the agency said in a statement.
“This information shows that ByHeart brand formula is disproportionately represented among sick infants in this outbreak, especially since ByHeart represents approximately 1% of all infant formula sales in the United States,” the FDA statement said.
ByHeart produces infant formula powder at a plant in Allerton, Iowa, then ships it to a site in Portland, Oregon, for canning and distribution, Kuehn said. U.S. Food and Drug Administration inspectors were at the Portland plant Monday, she added.
In addition to the broad recall, the company said it tests each batch of formula with an independent third-party laboratory, providing health officials with full access to its sites and sharing results with regulators as they become available.
Infant botulism is a rare and serious disease that occurs in babies under one year of age, whose intestinal microbiota is immature. This occurs when infants consume bacteria containing spores that produce a toxin in the intestine. Symptoms include constipation, poor diet, drooping eyelids, low muscle tone, difficulty swallowing and breathing problems, among others.
Babies who develop these symptoms need immediate medical attention. The only treatment for the infection is BabyBIG, an IV medication made from blood plasma from people who are immune to botulism.
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