The New Jersey Department of Health is alerting parents and caregivers about an ongoing multistate outbreak of infant botulism linked to recalled ByHeart Whole Nutrition Infant Formula. The outbreak, which has sickened infants in 12 states, includes one hospitalization in New Jersey.
“While infant botulism remains rare, it is a serious illness that requires immediate medical attention. We urge parents and caregivers to check their infant formula and stop using any product from the affected lots,” said Acting Health Commissioner Jeff Brown.
The Centers for Disease Control and Prevention (CDC), the U.S. Food and Drug Administration (FDA), and state health officials are investigating 15 reported cases of infant botulism, all of which involved infants who consumed ByHeart Whole Nutrition Infant Formula.
Initially, ByHeart voluntarily recalled two lots of its product, but on Tuesday the company expanded the recall to include all ByHeart infant formula nationwide, including both cans and single-serve sticks.
ByHeart Whole Nutrition Infant Formula is sold online and at major retailers across the United States, though it represents less than 1% of all infant formula sold nationally, according to the FDA. The company’s products are certified Kosher by the Orthodox Union (OU).
Parents and caregivers are urged to immediately stop using any ByHeart Whole Nutrition Infant Formula, dispose of the product safely, and clean any items or surfaces that may have come into contact with it using hot, soapy water or a dishwasher.
Symptoms of infant botulism can take several weeks to develop and may include constipation, poor feeding, loss of head control, weak facial expression, and difficulty swallowing—symptoms that can progress to respiratory distress. Infants who have consumed the recalled formula and develop symptoms should receive immediate medical attention. Prepared formula already fed to infants should be stored for at least a month for potential testing if symptoms appear.
Infant botulism occurs when spores from the bacteria Clostridium botulinum infect an infant’s large intestine and produce a toxin that affects the nervous system. Most cases occur in infants under six months old. Other common exposures include honey (which should not be given to infants under one year old) and contact with soil or dust, particularly near construction sites.
Treatment involves an intravenous medication known as BabyBIG (botulism immune globulin), which neutralizes the toxin. With timely treatment, most infants make a full recovery.
Officials emphasize that the current recall is not expected to cause infant formula shortages.
The CDC, FDA, and state health departments continue to investigate the outbreak, which has affected infants in Arizona, California (2), Illinois (2), Kentucky, Minnesota, New Jersey, North Carolina, Oregon, Pennsylvania, Rhode Island, Texas (2), and Washington.