
State health officials are investigating a suspected case of infant botulism in North Carolina linked to a baby formula, which has now been recalled nationwide. The North Carolina Department of Health and Human Services (NCDHHS) announced Tuesday that the recall was expanded after more than a dozen infants across the country became ill, prompting renewed warnings for parents to check their formula supplies.
The North Carolina Department of Health and Human Services (NCDHHS), along with the North Carolina Department of Agriculture & Consumer Services, issued a joint alert on Tuesday, regarding an expanded recall of ByHeart Inc. Whole Nutrition Infant Formula.
“Botulism is a rare but serious paralytic illness caused by a nerve toxin produced by a bacteria known as Clostridium botulinum,” the statement warned. “All forms of botulism can be fatal and are considered medical emergencies.”
The recall follows a multi-state outbreak of infant botulism linked to the product. According to federal data, as of November 10, at least 15 infants across 12 states have been hospitalized after consuming the formula. NCDHHS said there is one suspected case currently under investigation in North Carolina.
NC Agriculture Commissioner Steve Troxler said in a press release issued November 11, 2025 that the NC Department of Agriculture’s Food and Drug Protection Division is working with NCDHHS, the US Food and Drug Administration, and retailers on the recall.
“However, 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,” said Troxler.
NCDHHS sent a message to providers across the state on Monday warning of the recall.
Health officials say that symptoms of infant botulism may take several weeks to appear and include poor feeding, difficulty swallowing, loss of head control and respiratory distress. Families who have used the recalled formula are advised to monitor their infants closely and seek immediate medical attention if symptoms develop.
“Infant botulism is a serious illness and can be life-threating,” said Dr. Kelly Kimple, Director of the NCDHHS Division of Public Health in the release. “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.”
The recalled product represents about 1% of US infant‐formula sales. Health officials advise caregivers to immediately stop using the product and throw it away, or return it to the store where it was purchased. Any items and surfaces it may have touched should be washed with hot soapy water or a dishwasher.
“If possible, you should record the lot number or take a picture of the product prior to disposal or return of the product,” the press release advised.
For more information and recall details, visit the NCDHHS website.
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