ByHeart recalls all baby formula sold nationwide as infant botulism outbreak grows

ByHeart Organic Baby Formula Recalled Nationwide Due to Infant Botulism Outbreak

By JONEL ALECCIA, Associated Press Health Writer

ByHeart, a manufacturer of organic baby formula, issued a nationwide recall of all its products on Tuesday following the recall of some batches in an expanding outbreak of infant botulism. According to state and federal health officials, at least 15 babies in 12 states have been affected by the outbreak since August, with more cases pending. All infants were hospitalized after consuming ByHeart formula, but no deaths have been reported.

The voluntary recall now includes all products in consumers’ homes and in stores, such as ByHeart Whole Nutrition Infant Formula and Anywhere Pack pouches of powdered formula. The company, which sells about 200,000 cans of infant formula a month, has urged parents and caregivers to immediately stop using and dispose of the product.

Despite no unopened ByHeart product testing positive for contamination, the company initiated the recall in collaboration with the U.S. Food and Drug Administration. A sample from an open can of ByHeart baby formula fed to a sick infant in California was found to contain the bacteria linked to the outbreak.

The FDA is currently investigating 84 cases of infant botulism detected since August, with a significant number of cases involving ByHeart formula. ByHeart is conducting thorough testing of every batch of formula with an independent laboratory and providing health officials full access to its facilities.

Infant botulism is a rare but serious illness that affects babies under age 1. Symptoms include constipation, poor feeding, drooping eyelid, weak muscle tone, difficulty swallowing, and breathing problems. Immediate medical attention is required for babies showing these symptoms, with treatment involving BabyBIG, an IV medication made from the blood plasma of individuals immunized against botulism.

The Associated Press Health and Science Department is supported by the Howard Hughes Medical Institute’s Department of Science Education and the Robert Wood Johnson Foundation.