The U.S. Food and Drug Administration has linked an outbreak of infant botulism to the recall of Whole Nutrition Infant Formula manufactured by ByHeart Inc.
Infant botulism is a serious illness caused by a bacteria called Clostridium botulinum, according to the Centers for Disease Control and Prevention.
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At least 15 cases have been identified across twelve states, according to the CDC and FDA.
NCDHHS reports North Carolina is investigating one suspected case in an infant.
On Monday, officials said the state's FDA division is working with the U.S. FDA and the state’s Department of Health and Human Services on the recall, and working with retailers to make sure they are aware of the recall and removing the formula from shelves.
Dr. Daniel Park, medical director of UNC Children’s Emergency Department, told WRAL the illness is rare, but something UNC Health has seen in young patients before. He warned parents and caregivers, “This is not something to be taken lightly.”
“There have been outbreaks and it’s not unheard of,” he said. “The patient population we’re worried about is children less than one year old because their guts are very immature. Death is very rare in these circumstances, but we’ve seen kids who are quite sick requiring mechanical ventilation and ICU visits.”
Tap to watch: Local mom worries about recalled formula she said she just fed her baby
One Butner mother told WRAL she fed her baby a bottle using the formula just minutes before finding out it had been recalled.
“My son was taking a nap when I realized it,” said Aimee Finley, who said she was notified of the recall by a phone call from Target early Tuesday morning.
She said right now she is monitoring for any symptoms.
“Hopefully it’s nothing,” she continued.
She is far from the only mom watching out.
Park said young children cannot process the bacteria the same as older children and adults.
“In kids, their gut bacteria are so immature it can’t neutralize those spores and those spores grow in the stomach, and then pass into the intestine where the toxin is formed,” Park shared. “That’s where that toxin will wreak havoc on the body.”
The bacteria can impact the muscular system in young children, causing paralysis and muscle weakness.
“Other things that can be presented in children or young infants is they don’t suck or take the bottle well, their feeding becomes very poor, they can get very floppy, and in the worse cases, the muscles that drive breathing – the diaphragm and intercostal muscles – those get weak and the patients have trouble breathing,” he warned.
Park stated that the speed at which symptoms begin varies, ranging from a few days to a few weeks, depending on the child. He warned that things can progress quickly once they start.
North Carolina Agriculture Commissioner Steve Troxler advised parents and caretakers to take extra precautions.
“This product is readily available online and may be in home pantries, so parents need to check to be sure they are not feeding the product to their infants.”
Officials with the FDA said two lots of the infant formula has been voluntarily recalled.
· Lot: 206VABP/251261P2 ("Use by 01 Dec 2026")
· Lot: 206VABP/251131P2 ("Use by 01 Dec 2026")
NCDHHS officials warn that infant botulism can be life-threatening.
“NCDHHS is working with our public health and healthcare partners to be sure parents are not using the recalled formula so more babies in North Carolina won’t be exposed,” said Dr. Kelly Kimple, director of the NCDHHS Division of Public Health.
Anyone who has purchased an impacted lot of the recalled formula should not use it, and throw it away or return it to where they bought it from.
Officials also encourage washing any items and surfaces that may have touched the recalled formula using hot soapy water or a dishwasher. If possible, officials said parents or caretakers should record the lot number or take a picture of the product before throwing it away.
