ByHeart, an organic baby formula manufacturer, has initiated a voluntary recall of all its products sold in the United States due to an outbreak of infant botulism. This decision comes just days after the company had previously recalled two specific lots. As of now, at least 15 infants across 12 states have been affected since August 2023, with all hospitalized after consuming ByHeart formula. No fatalities have been reported.
The recall encompasses all ByHeart products currently in consumers’ homes and available in stores, including the ByHeart Whole Nutrition Infant Formula and Anywhere Pack pouches. The company, which sells approximately 200,000 cans of infant formula monthly through retailers such as Target, Walmart, Albertsons, and Whole Foods, urged parents and caregivers to “immediately discontinue use and dispose of the product,” according to Dr. Devon Kuehn, the chief medical officer of ByHeart.
The unusual decision to expand the recall was made in close collaboration with the U.S. Food and Drug Administration (FDA), despite no unopened ByHeart products testing positive for contamination. Health officials in California confirmed that a sample taken from an open can of ByHeart formula, which had been fed to an infant who fell ill, contained the bacteria responsible for the botulism toxin.
This proactive measure highlights ByHeart’s commitment to safety, as stated in a company announcement: “This action underscores ByHeart’s core mission: protecting babies above all else.”
The FDA is currently investigating 84 cases of infant botulism reported since August, with 36 cases linked to infant formula. Notably, more than a third of these cases involved ByHeart products. The FDA noted that the brand’s formula is disproportionately represented among the sick infants, especially given that ByHeart accounts for only around 1% of all infant formula sales in the United States.
ByHeart produces its formula powder at a facility in Allerton, Iowa, before shipping it to a site in Portland, Oregon for canning and distribution. Inspectors from the FDA are currently present at the Portland facility to monitor the situation closely.
In addition to the extensive recall, ByHeart is implementing rigorous testing protocols for each batch of formula using an independent third-party laboratory. The company has opened its facilities to health officials and is committed to sharing test results with regulators as they become available.
Infant botulism is a rare but serious condition that affects babies under one year of age. It occurs when infants consume spores of bacteria that produce toxins in the gut. Symptoms can include constipation, poor feeding, drooping eyelids, weak muscle tone, and breathing difficulties.
As the investigation progresses, ByHeart remains focused on ensuring the safety of its products and protecting the health of infants.
