Botulism Found in Infant Formula

A recent outbreak of infant botulism has prompted a nationwide recall of ByHeart Inc. Whole Nutrition Infant Formula.

The NC Department of Health and Human Services and state Department of Agriculture and Consumer Services are alerting providers, parents and caregivers to the danger. As of November 8, 2025, 13 cases had been confirmed across 10 states, according to the US Food and Drug Administration. There is one suspected case currently under investigation in North Carolina.

Currently, two lots of ByHeart Inc. Whole Nutrition Infant Formula have been voluntarily recalled to date, with investigations ongoing:

• Lot: 206VABP/251261P2 (“Use by 01 Dec 2026”)
• Lot: 206VABP/251131P2 (“Use by 01 Dec 2026”)

NC Agriculture Commissioner Steve Troxler said, “Our Food and Drug Protection Division is working with … the Food and Drug Administration and NCDHHS … and also working with retailers to make sure they have been notified about the recalled product and are removing it from store shelves. 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.”

Botulism is a rare but serious paralytic illness caused by a nerve toxin produced by a bacteria known as Clostridium botulinum. All forms of botulism can be fatal and are considered medical emergencies.

NCDHHS sent a provider memo to health care providers as they should be alert of infants with symptoms consistent with infant botulism.

“Infant botulism is a serious illness and can be life-threating,” said Dr. Kelly Kimple, Director of the NCDHHS Division of Public Health, which is working with public health and healthcare professionals “to be sure parents are not using the recalled formula.”

If you have purchased an impacted lot of ByHeart Inc. Whole Nutrition Infant Formula, do not use the formula; throw it away or return it to where you bought it. You should also wash items and surfaces that may have touched the recalled formula using 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.

Symptoms of infant botulism can take as long as several weeks to develop, so parents should remain vigilant if they used the recalled lots. Parents or guardians should seek immediate medical care if your infant consumed ByHeart Inc. Whole Nutrition Infant Formula and has any of these symptoms:

• Poor feeding
• Difficulty swallowing
• Decreased facial expression
• Loss of head control
• Respiratory difficulty

ByHeart Inc. Whole Nutrition Infant Formula represents about 1% of infant formula sales across the country, so the recall does not create shortage concerns. It is not a SNAP/WIC eligible product, and there are many other options caregivers can use.