ByHeart Inc., the next-generation baby nutrition company at the center of a nationwide infant formula recall, is being sued by the parents of at least two babies sickened amid an ongoing infantile botulism outbreak.
On Nov. 8, in the midst of an infant botulism outbreak investigation by the Food and Drug Administration and the Centers for Disease Control and Prevention, ByHeart voluntarily recalled two batches of its ByHeart Whole Nutrition Infant Formula "out of an abundance of caution." On Nov. 11, the company expanded its recall to include all batches of ByHeart Whole Nutrition Infant Formula cans and Anywhere Pack nationwide.
As of Friday, Nov. 14, a total of 23 infants with suspected or confirmed infant botulism and confirmed exposure to ByHeart Whole Nutrition infant formula (various lots) have been reported from 13 U.S. states, according to the FDA. So far, no deaths have been reported, but all 23 infants were hospitalized, the agency said.
Two families, Stephen and Yurany Dexter of Flagstaff, Arizona, and Michael and Hanna Everett of Richmond, Kentucky, filed complaints in federal courts against ByHeart after their babies contracted the rare and potentially deadly disease. Both families allege that ByHeart is directly responsible for their infant children being sickened with botulism.
