NJDOH Issues Alert Over Infant Botulism Linked to Recalled Baby Formula

One NJ infant hospitalized amid multistate outbreak tied to ByHeart Whole Nutrition Formula; parents urged to stop use immediately and monitor infants for symptoms.

MORRISTOWN, N.J. — The New Jersey Department of Health (NJDOH) is warning parents and caregivers about an ongoing investigation into a multistate outbreak of infant botulism illnesses linked to ByHeart Whole Nutrition Infant Formula, which has now been recalled nationwide.

To date, 15 cases have been reported across 12 states, including one hospitalization in New Jersey. All affected infants had consumed ByHeart formula, according to the U.S. Food and Drug Administration (FDA).

Although the initial recall affected only two lots, ByHeart has expanded the recall to include all formula products—including both cans and single-serve sticks—sold online and in major retail stores across the U.S.

“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."

What Parents and Caregivers Should Do

• Immediately stop using any ByHeart Whole Nutrition Infant Formula (regardless of size or packaging).

• Clean all items and surfaces that may have come into contact with the formula using hot, soapy water or a dishwasher.

• Monitor infants for symptoms of botulism, which may take several weeks to develop.

Symptoms of Infant Botulism

Early symptoms include:

• Constipation, Poor feeding, Weak cry or facial expression, Loss of head control, Difficulty swallowing or breathing.

If any symptoms occur, seek medical attention immediately. Prepared formula that has been consumed should be stored for at least one month for potential testing by public health officials, should symptoms appear.

Understanding Infant Botulism

Infant botulism occurs when spores from the Clostridium botulinum bacterium are ingested and produce toxins in an infant’s intestines. Because babies under 6 months have underdeveloped gut flora, the bacteria can grow more easily and affect the nervous system.

Treatment involves BabyBIG (botulism immune globulin intravenous), which neutralizes the toxin and is effective in aiding recovery. Most infants recover fully with prompt care.

Broader Context

The CDC, FDA, and state health agencies continue to investigate. Botulism illnesses connected to this outbreak have been reported in Arizona, California (2), Illinois (2), Kentucky, Minnesota, New Jersey, North Carolina, Oregon, Pennsylvania, Rhode Island, Texas (2), and Washington.

Other common exposures to botulism in infants under 12 months include:

• Honey or honey-containing products

• Environmental dust or soil, particularly near construction zones

NJDOH emphasized that the outbreak does not pose a supply concern for infant formula availability. However, immediate action is encouraged to prevent further illness.

For updates and more information on the recall and botulism symptoms, visit the FDA or NJDOH websites.