Nationwide Recall of ByHeart Infant Formula After Botulism Cases

The California Department of Public Health (CDPH) has initiated a nationwide recall of ByHeart Whole Nutrition Infant Formula following a multistate outbreak of infant botulism linked to the product. This decision comes after health officials reported a concerning rise in cases across ten states, prompting an immediate investigation by both state and federal health agencies.

Earlier this year, the CDPH’s Infant Botulism Treatment and Prevention Program detected an unusual increase in infant botulism cases. Further testing by the state’s public health laboratory identified the presence of Clostridium botulinum, the bacteria responsible for the botulism toxin, in a sample of ByHeart powdered formula. Since August 2023, a total of 13 suspected or confirmed cases of infant botulism have been reported, with eight of those cases confirmed as type A botulism.

On November 8, 2023, ByHeart Inc. announced the recall of two lots of its Whole Nutrition Infant Formula. The affected lot numbers are 206VABP/251261P2 and 206VABP/251131P2, both marked with a “Use by 01 Dec 2026” date. The formula was distributed online through ByHeart’s website and major retailers across the country, including Amazon, Target, Walmart, Whole Foods, and Kroger.

Dr. Erica Pan, Director and State Public Health Officer at CDPH, emphasized the rarity of infant botulism, stating, “Infant botulism is a very rare disease that occurs when babies inhale or swallow spores of the toxin-producing bacteria.” She urged parents to cease use of ByHeart formula immediately after preliminary tests indicated a connection to the recent cases.

Symptoms of infant botulism can manifest as constipation, difficulty feeding, a weak cry, poor head control, and reduced facial expression. In severe instances, the illness can lead to respiratory issues if not addressed promptly. Infants affected by this condition typically require hospitalization but can recover fully with early diagnosis and appropriate medical intervention.

The CDPH is advising parents to stop using the recalled product and to seek medical attention if their child exhibits any signs of illness. Parents are encouraged to retain any remaining formula packaging, including the lot number, to assist in the investigation. Healthcare providers are also urged to report suspected cases to local health departments to facilitate swift testing and treatment. For medical assistance, physicians treating potential cases can contact California’s Infant Botulism Treatment and Prevention Program at (510) 231-7600.

According to the U.S. Food and Drug Administration (FDA), ByHeart Whole Nutrition Infant Formula constitutes less than 1% of the nation’s infant formula supply. Officials have stated that the recall is not expected to disrupt the overall availability of formula for parents and caregivers.

For further details regarding the recall and ongoing investigation, additional information is available on the websites of the California Department of Public Health and the U.S. Food and Drug Administration.