A possible ByHeart infant formula botulism outbreak has sickened 13 babies, according to the Center for Disease Control and Prevention (CDC). All 13 infants have been hospitalized. Two lots of the company’s infant formula have been recalled. The formula was sold online and nationwide at the retail level.
The case count of babies with suspected or confirmed infant botulism by state is: Arizona (1), California (2), Illinois (2), Minnesota (1), New Jersey (1), Oregon (1), Pennsylvania (1), Rhode Island (1), Texas (2), and Washington (1). Illness onset dates range from mid-August to November 2025. All 13 infants were treated with BabyBIG®. The infants range in age from 15 to 157 days old.
Public health officials have been interviewing caregivers about the foods these babies were fed before they got sick. All 13 consumed ByHeart Whole Nutrition Infant Formula. Testing of the formula is underway; results should be announced in a few weeks.
The company states that, “The FDA has not identified a direct link between any infant formula and these cases and there is no historical precedent of infant formula causing infant botulism.”
The FDA has been in contact with the firm and recommended the recalll. And the FDA is ensuring that all potentially affected products are removed from the marketplace.
Food Safety Attorney and Food Poisoning Bulletin Publisher Eric Hageman
Noted food safety attorney Eric Hageman, who has represented many families whose infants have been sickened by formula, said, “There is nothing more heartbreaking than seeing a tiny infant seriously ill and in the hospital. We hope that all of these infants recover completely and go on to live full and healthy lives..”
Botulism toxin is produced by the bacteria Clostridium botulinum. Under certain conditions, spores that the bacteria produces make the toxin. In infants, the spores are swallowed and the spores produce the toxin in the baby’s large intestine.
Symptoms of botulism poisoning in an infant are different from symptoms in older children and adults. The first symptom is typically constipation, but is first usually noticed by parents as difficulty feeding (sucking and swallowing), a weak and different cry, and loss of muscle tone, along with loss of head control and decreased facial expression. If untreated, infants can suffer a progressive, flaccid paralysis that can lead to breathing difficulties. These babies typically require weeks of hospitalization.
If your infant has been fed any of the recalled formula, watch carefully for any signs of botulism poisoning. The symptoms can take several weeks to develop. A baby experiencing these symptoms needs to see a doctor immediately.
If your baby has been sickened with botulism poisoning, please contact our experienced attorneys for help with a possible lawsuit at 1-888-377-8900 or text us at 612-261-0856. Our firm represents clients in lawsuits against grocery stores, restaurants, and food processors.
