Washington, D.C., USA- January 13, 2020: FDA Sign at its headquarters in Washington DC. The Food and Drug Administration (FDA or USFDA) is a federal agency of the USA.
Washington, D.C. – The U.S. Food and Drug Administration (FDA) has broadened a nationwide recall of all ByHeart Whole Nutrition Infant Formula products due to a rising outbreak of infant botulism associated with the powdered formula.
The recall now encompasses all unexpired cans and single-serve “anywhere” sticks of the formula, which are available both online and in major retailers throughout the country.
Federal officials report that at least 15 infants from 12 states have been hospitalized with suspected or confirmed cases of infant botulism after consuming ByHeart formula. Fortunately, no fatalities have been recorded.
The states affected include Arizona, California, Illinois, Kentucky, Minnesota, New Jersey, North Carolina, Oregon, Pennsylvania, Rhode Island, Texas, and Washington. The illnesses were documented between August 9 and November 10, 2025.
Laboratory testing conducted by the California Department of Public Health’s Infant Botulism Treatment and Prevention Program (IBTPP) found preliminary evidence of Clostridium botulinum bacteria—the organism that produces the deadly botulinum toxin—in an open can of ByHeart formula linked to one of the cases. Further testing is underway.
“Due to the number of reported illnesses, new positive lab results, and ongoing investigations, we are advising all parents and caregivers to stop using any ByHeart infant formula products immediately,” the FDA said in a statement.
The Centers for Disease Control and Prevention (CDC) has reported that, as of August 1, 2025, 84 infants across the country have been treated for infant botulism. Among these cases, 36 infants had ingested powdered formula, with 15 of those cases linked to ByHeart products. Notably, ByHeart represents less than 1% of the U.S. infant formula market, which makes its incidence among affected infants disproportionately high.
Common symptoms of infant botulism include constipation, poor feeding habits, loss of head control, difficulty in swallowing, and muscle weakness. If left untreated, this illness can result in respiratory failure. Parents whose infants have consumed ByHeart formula and exhibit these symptoms are strongly encouraged to seek immediate medical assistance.
The FDA, CDC, and state health agencies are actively investigating the source of the contamination and are monitoring for any further cases. Physicians who suspect a case of infant botulism are recommended to reach out to the IBTPP for consultation at 510-231-7600, which is available 24/7.
Consumers are urged to keep affected formula containers for possible testing, label them “Do Not Use,” and dispose of them after 30 days if no illness occurs.
ByHeart’s recall expansion, issued November 11, 2025, marks the company’s second major action in response to the outbreak. Earlier this month, ByHeart had recalled two specific formula lots before widening the recall to include all of its infant formula products nationwide.
