ByHeart Recalls Infant Formula Lots Linked to a 10-State Botulism Outbreak

A maker of organic infant formula is recalling two lots of its powdered product after federal officials linked it to an outbreak of infant botulism in 10 states, NBC News and CBS News reported. The 10 states are Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas and Washington, according to NBC and CBS.

The Food and Drug Administration said 13 children have been hospitalized since August after consuming ByHeart Whole Nutrition Infant Formula, and no deaths have been reported, NBC News reported. The recall announced Saturday covers two lots of the powdered formula with Dec. 1 “use by” dates, with lot numbers 206VABP/251261P2 and 206VABP/251131P2, the FDA said. The agency asked parents and caregivers to record identifying information from the packaging and “promptly throw it away,” and said it was working with retailers to remove “all potentially impacted product” from shelves.

The picture grew more serious within days. NBC News and CBS News reported on Nov. 11 (later source) that ByHeart expanded the voluntary recall to all of its formula, including its Anywhere Pack pouches. At least 15 babies in 12 states had been sickened by then, both outlets reported, and neither reported any deaths.

The FDA said 84 infants had been treated for infant botulism since August, NBC News reported (later source), and CBS News reported the agency was investigating 84 cases since August, with more cases pending. NBC reported that ByHeart had invited federal agencies to test unopened cans.

State health officials were testing leftover formula, with results expected in the coming weeks, NBC News reported on Nov. 9. The FDA was trying to determine the point of contamination and whether other products might be affected.

Infant botulism is caused by a toxin produced by bacteria. The CDC says symptoms include constipation, poor feeding, loss of head control and difficulty swallowing, and the condition can progress to paralysis and death, NBC News reported. The FDA investigation into the source of the outbreak was continuing.