Organic infant formula maker ByHeart has initiated a full nationwide recall of all its products in the United States, following reports of at least 15 infants hospitalized with botulism across 12 states.
The company announced the comprehensive recall on Tuesday, expanding from an initial limited withdrawal of two product lots reported on Saturday. This decision was made in collaboration with the U.S. Food and Drug Administration (FDA) to ensure the highest level of consumer safety.
ByHeart’s recall encompasses all its products, including ByHeart Whole Nutrition Infant Formula and Anywhere Pack portable sachets. No contamination has yet been found in unopened cans.
However, U.S. federal and state health officials have confirmed that at least 15 infants in 12 states have suffered from botulism after consuming ByHeart formula since August. All affected infants required hospitalization, though no deaths have been reported.
California state health officials detected bacteria capable of producing botulinum toxin in an opened can of formula that had been used to feed an ill infant.
An FDA spokesperson stated the agency recommended the immediate expansion of the recall. This recommendation came after an observed upward trend in patient cases, the identification of additional product lot codes, and confirmed test results from California.
Dr. Steven Abrams, from the Dell Medical School at the University of Texas Austin, urged parents to immediately stop using any ByHeart formula listed in the recall.
ByHeart’s Chief Medical Officer, Dr. Devon Kuhn, described the recall as a proactive measure to mitigate risk. He noted there is still no definitive evidence linking the formula’s recipe directly to the outbreak.
The illnesses were reported between August 9 and November 10. Affected states include Arizona, California, Illinois, Kentucky, Minnesota, North Carolina, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, and Washington.
Officials have not identified any links to other infant formula brands or other sources of contamination beyond ByHeart products.
Botulism is caused by toxins produced by the bacterium Clostridium botulinum. The condition affects the nervous system, leading to muscle weakness and difficulty breathing, and can be life-threatening. In infants, it is typically contracted through contaminated food or milk.
ByHeart sells over 200,000 cans of its formula monthly, through its website and major retailers such as Target, Walmart, Albertsons, and Whole Foods.