NJDOH Alerts Parents and Caregivers of Ongoing Investigation of Infant Botulism

TRENTON, NJ - The New Jersey Department of Health alerts parents and caregivers of an ongoing investigation related to a multistate outbreak of infant botulism illnesses linked to recalled infant formula sold as ByHeart Whole Nutrition Infant Formula. To date, the illnesses have been reported in 12 states, with one case hospitalized 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 New Jersey Acting Health Commissioner Jeff Brown. "Quick recognition of symptoms and prompt treatment are key. Our priority is ensuring every infant's safety as we work with our federal and state partners to investigate this outbreak and prevent future cases."

All 15 cases included in this outbreak are reported to have consumed ByHeart Whole Nutrition Infant Formula. The recalled infant formula is sold online and at major retailers nationwide and accounts for an estimated less than 1% of all infant formula sold in the United States, according to the Food and Drug Administration (FDA).

Although the initial voluntary recall affected two lots of the product, ByHeart today expanded its recall to all its infant formula nationwide, including formula sold in cans and single-serve sticks.

Parents and caregivers are advised to immediately stop the use of ByHeart Whole Nutrition infant formula, including all sizes of cans and single serve sticks. Wash items and surfaces that may have touched the recalled formula using hot soapy water or a dishwasher.

Most infants with infant botulism will initially develop constipation, poor feeding, loss of head control, poor facial expression, and difficulty swallowing, which can progress to difficulty breathing and respiratory arrest. Symptoms of infant botulism, which is diagnosed clinically, can take as long as several weeks to develop following formula ingestion.

Parents and caregivers should monitor their infants for symptoms. If symptoms develop, seek medical care immediately. Leftover formula already prepared and fed to infants should be stored for at least one month to allow for collection and testing by public health officials if the infant develops symptoms. If the infant does not develop symptoms, the leftover product can be discarded.

Infant botulism happens when swallowed spores from a bacteria called Clostridium botulinum infect a baby's large intestine and produce a toxin in it. Because the infant intestinal flora and digestive system are less mature, they allow spore germination and start to produce a toxin which then enters a baby's bloodstream and eventually disrupts the baby's nervous system.

Infant botulism is treated with botulism immune globulin intravenous (BIGIV), often called BabyBIG, which is administered as soon as possible to neutralize the toxin. Most babies make a full recovery with treatment.

Most cases of infant botulism occur in infants under six months. More common risk exposures to botulism include ingestion of honey (or items with honey) in infants under 12 months and environmental exposure to soil/dust spores (e.g., proximity to construction sites).

The Centers for Disease Control and Prevention (CDC) and public health officials in several states, the Infant Botulism Treatment and Prevention Program, and the FDA are continuing to investigate the outbreak. To date, infant botulism illnesses in this outbreak have been reported in the following states: Arizona, California (2), Illinois (2), Kentucky, Minnesota, New Jersey, North Carolina, Oregon, Pennsylvania, Rhode Island, Texas (2), Washington.

The outbreak does not create shortage concerns of infant formula for parents and caregivers.

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The New Jersey Department of Health is a nationally accredited health department working to ensure that all New Jerseyans live long, healthy lives and reach their fullest potential. With more than 5,500 employees, the Department serves to protect the public's health, promote healthy communities, and continue to improve the quality of health care in New Jersey. 

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