Infant Botulism Cases Linked to Recalled Baby Formula in 10 States

Federal and state health officials are investigating 13 cases of infant botulism across ten states connected to recalled baby formula manufactured by ByHeart Inc., a development that underscores the critical importance of formula safety monitoring.

ByHeart Inc. initiated a voluntary recall of two lots of its Whole Nutrition Infant Formula – lots 206VABP/251261P2 and 206VABP/251131P2 – after the cases were reported. The illnesses occurred in Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, and Washington, with all 13 infants requiring hospitalization. No deaths have been reported to date.

“The safety and well-being of every infant who uses our formula is our absolute highest priority,” said Mia Funt, ByHeart’s co-founder and president, in a statement. “We take any potential safety concern extremely seriously, and act quickly to protect families. This voluntary recall is out of an abundance of caution and comes from our ongoing commitment to transparency and safety for babies and their parents.” The recalled product represents approximately 1% of national formula sales, according to the U.S. Centers for Disease Control and Prevention.

Infant botulism is caused by a toxin produced by a bacterium in the large intestine, and symptoms can take weeks to appear. Parents should seek immediate medical attention if their infant exhibits poor feeding, loss of head control, difficulty swallowing, or decreased facial expression, as detailed in information about the FDA’s investigation. The FDA is currently working to determine the source of the contamination and whether other products may be affected.