Published August 17, 2026
The U.S. Judicial Panel on Multidistrict Litigation centralized federal lawsuits against ByHeart, Inc. into a new multidistrict litigation, MDL No. 3178, in a transfer order issued April 2, 2026. The cases — captioned In re: ByHeart, Inc., Infant Formula Marketing, Sales Practices, and Products Liability Litigation — were consolidated in the Southern District of New York before Judge Arun S. Subramanian. The panel found the cases shared common factual questions arising from ByHeart's November 2025 recall of its Whole Nutrition Infant Formula, which the company pulled from shelves after the products were linked to an outbreak of infant botulism potentially caused by contamination with Clostridium botulinum bacteria.
According to the CDC, dozens of infants across numerous states were hospitalized with botulism after being fed the recalled formula. The consolidated lawsuits include two groups of claims: cases brought on behalf of infants who became seriously ill, and separate proposed class actions seeking to recover money for parents who purchased formula that was later recalled.
ByHeart's botulism litigation is a distinct case from the ongoing multidistrict litigation over Abbott's Similac and Mead Johnson's Enfamil formulas, which centers on allegations that cow's-milk-based formula causes necrotizing enterocolitis (NEC) in premature infants. The ByHeart cases instead allege a manufacturing or quality-control failure that let bacterial contamination reach store shelves, causing an acute illness rather than the chronic condition at issue in the NEC cases.
If your infant was hospitalized with botulism after being fed ByHeart formula, see Atumio's ByHeart infant formula case page for a free, no-obligation review, or start your case review directly.