ByHeart, a manufacturer of organic baby formula, recalled all of its products sold nationwide Tuesday, days after some batches were recalled in an expanding outbreak of infant botulism.
At least 15 babies in 12 states have been sickened in the outbreak since August, with more cases pending, according to state and federal health officials. All of the infants were hospitalized after consuming ByHeart formula, officials said. No deaths have been reported.
ByHeart officials expanded the voluntary recall from two lots announced Saturday to all products in consumers’ homes and in stores. That includes ByHeart Whole Nutrition Infant Formula and Anywhere Pack pouches of powdered formula. The company sells about 200,000 cans of infant formula a month online and in stores such as Target, Walmart, Albertsons and Whole Foods, according to Dr. Devon Kuehn, chief medical officer.
Parents and caregivers who have the formula in their homes “should immediately discontinue use and dispose of the product,” Kuehn said.
Company officials said they enacted the unusual recall “in close collaboration” with the U.S. Food and Drug Administration even though no product that was previously unopened tested positive for the contamination. The type of bacteria that produces the toxin is widespread in the environment and could come from sources other than the formula, company officials said.
“This action underscores ByHeart’s core mission: protecting babies above all else,” the company said in a statement.
California health officials earlier confirmed that a sample from an open can of ByHeart baby formula fed to an infant who got sick contained the toxin-producing type of bacteria.
The U.S. Food and Drug Administration recommended that ByHeart expand its recall because of the number of ill infants that reported consuming the formula, the identification of additional lot codes, the growing case count and the results of the California testing.
The FDA is investigating 84 cases of infant botulism detected since August. Of those, 15 consumed 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 given that ByHeart represents an estimated 1% of all infant formula sales in the United States,” the FDA statement said.
Illnesses began between Aug. 9 and Nov. 10, federal officials said. Cases were reported in Arizona, California, Illinois, Kentucky, Minnesota, North Carolina, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas and Washington.
Investigators have not identified any other infant formula brands or other sources of exposure in the outbreak, officials said.
ByHeart produces formula powder at a plant in Allerton, Iowa, and 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 is testing every batch of formula with an independent third-party laboratory, providing health officials full access to its sites and sharing results with regulators as they become available.
Infant botulism is a rare and serious illness that occurs in babies under age 1, whose gut microbiomes are immature. It is caused when the infants consume bacteria that contain spores that produce a toxin in the gut. Symptoms include constipation, poor feeding, drooping eyelid, weak muscle tone, difficulty swallowing and breathing problems, among others.
Babies who develop those symptoms need immediate medical attention. The sole treatment for the infection is BabyBIG, an IV medication made from blood plasma of people immunized against botulism.
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