ByHeart baby formula recalled amid 10-state outbreak of infant botulism

An organic infant formula maker is recalling part 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 included 13 hospitalizations since August of children who consumed ByHeart Whole Nutrition infant formula.

No deaths have been reported.

The recall includes two lots of powdered formula with expiration dates set for Dec. 1, the FDA said in a statement Saturday. The lot numbers are 206VABP/251261P2 and 206VABP/251131P2.

The FDA has asked parents and guardians who own the product to record the identifying information at the bottom of the package and throw it away promptly. It said it was 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 feeding, loss of head control, difficulty swallowing and can ultimately lead to paralysis and death, according to the Centers for Disease Control and Prevention.

The FDA said parents and caregivers who recently gave their children ByHeart should monitor them closely as a precaution because botulism can take weeks to develop.

Cases of infant botulism linked to 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 that the FDA has tracked about 83 reports of infant botulism across the country since August and that 13 babies consumed the formula. He said government tests and his own have yet to reveal the presence of botulism in his product.

“ByHeart is taking proactive steps to eliminate any potential risks from the market and ensure the highest level of safety for infants,” the company said. “The FDA has not identified any direct link between infant formula and these cases and there is no historical precedent of infant formula causing infant botulism.”

The FDA said officials in several states are testing leftover formula and results should be available in the coming weeks. The agency said it was trying to determine “the point of contamination and whether other products are affected.”

California Department of Public Health officials separately reported an increase in infant botulism in babies who consumed ByHeart since August, the FDA said.

ByHeart focuses on healthier foods for infants, made with organic grass-fed whole milk, which is closer in composition to breast milk, according to the company’s website. The company says its facilities in Iowa, Pennsylvania and Oregon produce infant formula sold at nearly 12,000 retailers.

FDA says ByHeart makes up less than 1% of infant formula sold in U.S.

Infant botulism can be treated with BabyBIG, an FDA-approved “orphan drug” composed of antibodies intended to fight botulinum neurotoxins, according to the California Department of Public Health.