Elemental Formula (Amino Acid-Based Infant Formula)

An elemental formula is a specialized formula whose protein comes from free amino acids, the basic building blocks of protein, rather than intact cow's milk or soy protein. Because there is no whole protein to react to, it is used for infants and children with severe cow's milk protein allergy, multiple food allergies, eosinophilic disorders, or conditions that make digestion difficult. Well-known brands include EleCare, Neocate, and PurAmino. These products are often prescribed and can be expensive.

Because the babies who need these formulas are often medically fragile, supply and safety problems hit families especially hard. On February 17, 2022, Abbott recalled certain powdered Similac, Alimentum, and EleCare formulas made at its Sturgis, Michigan plant after consumer complaints of Cronobacter sakazakii and Salmonella Newport infections in infants. The recall and plant shutdown contributed to a nationwide formula shortage that year, and families of elemental formula users had few alternatives.

That recall led to personal injury lawsuits by families of infants who became ill, economic loss class actions by parents who bought recalled formula, and shareholder suits. Separately, preterm infant formula has been the subject of lawsuits alleging a link to necrotizing enterocolitis (NEC), a serious bowel disease in premature babies; those cases involve cow's milk-based products for preemies, not elemental formulas for allergic infants.

If your child was sickened by formula, keep the container, lot number, and receipts, and get medical records documenting the infection. Our baby formula NEC lawsuit page and food recalls page explain related claims.