An organic baby food maker is recalling some of the product after federal officials linked it to an outbreak of infant botulism in 10 states.
The U.S. Food and Drug Administration said the outbreak has included 13 hospitalizations of children who consumed ByHeart Whole Nutrition infant formula since August.
No deaths were reported.
The recall includes two lots of the powder formula with an expiration date of Dec. 1, the FDA said in a release. statement on Saturday. Lot numbers: 206VABP/251261P2 and 206VABP/251131P2.
The FDA asked parents and guardians who have the product to write identifying information at the bottom of the package and throw it away immediately. The company said it is working with retailers to remove “all potentially affected products” from store shelves.
Infant botulism is a toxin produced by bacteria that can cause constipation, poor nutrition, loss of head control, difficulty swallowing and can ultimately lead to paralysis and death, according to Centers for Disease Control and Prevention.
The FDA said parents and caregivers who have recently fed ByHeart to their infants should monitor them closely as a precaution because botulism may take several weeks to develop.
Cases of infant botulism associated with ByHeart formula have been reported in Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas and Washington, the agency said.
In a statement, New York-based ByHeart said Friday the FDA had tracked approximately 83 reports of infant botulism across the country and that 13 children had consumed the mixture. The company said government and its own tests have not yet detected botulism in its product.
“ByHeart is taking proactive steps to remove any potential risk from the marketplace and ensure the highest level of safety for infants,” the company said. “The FDA has not identified a direct link between infant formula and these cases, and there is no historical precedent for infant formula causing infant botulism.”
The FDA said officials in several states are testing residues of the formula and that results are expected to be available in the coming weeks. The agency said it was trying to determine “the point of contamination and whether any additional products were affected.”
California Department of Public Health officials separately reported an increase in infant botulism among infants who consumed ByHeart since August, the FDA said.
ByHeart specializes in healthier baby foods made with organic, grass-fed whole milk, which it says is closer in composition to breast milk. according to the company's website. The company says its facilities in Iowa, Pennsylvania and Oregon produce formula milk that is sold at nearly 12,000 retailers.
The FDA says ByHeart makes up less than 1% of baby food sold in the United States.
Infant botulism can be treated with BabyBIG, an FDA-approved “orphan drug” that consists of antibodies to combat botulinum neurotoxins. California Department of Public Health.
Austin Mullen contributed.
