ByHeart baby formula recalls all products nationwide amid growing infant botulism outbreak
ByHeart, a manufacturer of organic baby formula, has issued a nationwide recall of all its products following an outbreak of infant botulism. The recall comes after at least 15 babies in 12 states fell ill after consuming ByHeart formula since August. All affected infants were hospitalized but fortunately, there have been no reported deaths.
The recall was expanded from two lots to include all ByHeart products, including the Whole Nutrition Infant Formula and Anywhere Pack pouches of powdered formula. This decision was made after the FDA discovered two additional cases of infant botulism in babies who had consumed ByHeart products.
ByHeart co-founders, Mia Funt and Ron Belldegrun, emphasized the importance of prioritizing baby safety in a letter posted on the company’s website. The company sells approximately 200,000 cans of infant formula each month through various retailers like Target, Walmart, Albertsons, and Whole Foods.
Parents and caregivers are urged to stop using the formula immediately and dispose of any products they have at home. ByHeart confirmed that no unopened cans of their formula have tested positive for contamination, but the recall will remain in place as the FDA investigates the cause of the botulism outbreak.
The company has initiated testing of every batch of formula with a third-party laboratory and has allowed access to its facilities for testing by regulatory authorities. California health officials have already confirmed the presence of the bacteria in a sample from an open can of ByHeart formula fed to a sick infant.
Infant botulism is a rare but serious illness that affects babies under the age of 1. Symptoms include constipation, poor feeding, muscle weakness, and breathing difficulties. Immediate medical attention is required for babies showing these symptoms, with treatment involving an IV medication called BabyBIG.
The FDA is currently investigating 84 cases of infant botulism, with a significant number of cases linked to the consumption of ByHeart formula. The company’s production facilities in Iowa and Oregon are under scrutiny, with FDA inspectors conducting inspections to identify the source of the contamination.
ByHeart remains committed to ensuring the safety of its products and will continue to cooperate with health authorities to address the ongoing outbreak. Parents are advised to stay informed about the recall and seek medical attention if their baby shows any symptoms of infant botulism.



