ByHeart, a company that manufactures organic baby formula, has issued a nationwide recall of all its products following an outbreak of infant botulism. The recall was expanded after at least 15 infants in 12 states were hospitalized since August after consuming ByHeart formula. No deaths have been reported.
Initially, ByHeart recalled two lots of its formula last Saturday, but the company decided to expand the recall to include all products in consumers’ homes and stores. This includes ByHeart Whole Nutrition Infant Formula and Anywhere Pack pouches of powdered formula. Dr. Devon Kuehn, chief medical officer at ByHeart, stated that the company sells about 200,000 cans monthly through online channels and retailers such as Target, Walmart, Albertsons, and Whole Foods.
Kuehn advised parents and caregivers: “should immediately discontinue use and dispose of the product.”
The decision to expand the recall was made “in close collaboration” with the U.S. Food and Drug Administration (FDA), according to company officials. They noted that no previously unopened product tested positive for contamination. The bacteria responsible for producing the toxin is commonly found in the environment and may come from sources other than the formula.
“This action underscores ByHeart’s core mission: protecting babies above all else,” said the company in a statement.
California health authorities confirmed that a sample from an open can of ByHeart formula given to a sick infant contained the toxin-producing bacteria.
The FDA recommended expanding the recall due to several factors: more infants reporting illness after consuming ByHeart formula, identification of additional lot codes, an increasing number of cases, and test results from California.
According to an FDA statement: “This information shows that ByHeart brand formula is disproportionately represented among sick infants in this outbreak, especially given that ByHeart represents an estimated 1% of all infant formula sales in the United States.”
Federal officials said illnesses began between August 9 and November 10. Cases have been reported in Arizona, California, Illinois, Kentucky, Minnesota, North Carolina, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, and Washington.
Investigators have not identified any other brands or sources linked to this outbreak.
ByHeart produces its powdered formula at a facility in Allerton, Iowa before shipping it to Portland, Oregon for canning and distribution. FDA inspectors visited the Portland plant on Monday.
In response to the situation, ByHeart is now testing every batch with independent third-party labs and providing full access to its facilities for health officials while sharing test results with regulators as they become available.
Infant botulism is rare but serious; it affects babies under one year old whose gut microbiomes are still developing. Symptoms include constipation, poor feeding habits, drooping eyelids, weak muscle tone, trouble swallowing or breathing problems. Immediate medical attention is necessary if symptoms appear. The only treatment is BabyBIG—an intravenous medication derived from blood plasma donated by people immunized against botulism.
