ByHeart, a maker of organic infant formula, recalled all of its products sold nationwide on Tuesday, days after some batches were recalled due to the expanding outbreak of infant botulism.
At least 15 babies in 12 states The outbreak has been causing illnesses since August, with more cases expected, state and federal health officials say. All of the infants were hospitalized after consuming ByHeart formula, officials said. No deaths were reported.
ByHeart officials expanded the voluntary recall from two batches announced Saturday to all products in consumers' homes and stores. These include ByHeart Whole Nutrition infant formulas and Anywhere Pack powder formulas. The company sells about 200,000 cans of baby food a month online and at stores such as Target, Walmart, Albertsons and Whole Foods, according to Dr. Devon Kuehn, chief medical officer.
Parents and guardians who have formula in the home “should immediately stop using and discard the product,” Kuehn said.
Company officials said they conducted the unusual recall “in close cooperation” with the U.S. Food and Drug Administration, “even though no unopened ByHeart products have tested positive” for this contamination.
California health officials previously confirmed that a sample from an open can of ByHeart baby food that was fed to an ill infant contained a type of bacteria that causes a toxin linked to the outbreak.
“This promotion underscores ByHeart’s core mission: protecting children above all else,” the company said in a statement.
The US Food and Drug Administration is investigating 84 cases of infant botulism identified since August. Of those, 36 were consuming baby formula, with more than a third receiving ByHeart formula, the agency said in a statement.
“This information shows that ByHeart brand formula is disproportionately represented among sick infants during this outbreak, especially given that ByHeart represents approximately 1% of all infant formula sales in the United States,” the FDA said in a statement.
ByHeart makes the powder mixes at a plant in Allerton, Iowa, and then ships them to a facility in Portland, Oregon, for canning and distribution, Kuehn said. U.S. Food and Drug Administration inspectors visited the Portland plant on Monday, she added.
In addition to the broad recall, the company said it tests every batch of formula in an independent third-party laboratory, giving health officials 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 infants under 1 year of age whose gut microbiome is immature. This disease occurs when infants consume bacteria containing spores that produce a toxin in the intestines. Symptoms include, but are not limited to, constipation, poor nutrition, drooping eyelids, poor muscle tone, difficulty swallowing, and breathing problems.
Infants who develop these symptoms need immediate medical attention. The only treatment for the infection is BabyBIG, an intravenous drug made from the blood plasma of people immunized against botulism.
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