Following years of consumer safety concerns, recalls, litigation and formula shortages that reshaped the infant nutrition industry, Abbott Nutrition has agreed to pay $670 million to resolve claims that its preterm infant formulas harmed infants, in addition to challenging a competitor’s advertising claims
Abbott did not admit liability as part of a settlement over claims that its specialty formulas for preterm infants caused necrotizing enterocolitis, a serious bowel disease.
Abbott agreed to pay approximately $670 million to resolve a case brough by a woman in Missouri and necrotizing enterocolitis (NEC) claims involving roughly 2,000 additional infants. The settlement includes a Missouri case in which a St. Louis jury awarded plaintiff Alexandra Gill $495 million in 2024 after finding Abbott liable for injuries related to NEC. After the Missouri Court of Appeals denied Abbott’s appeal, the company agreed to settle the case rather than continue legal proceedings.
“These agreements are a compromise of disputed claims and not in any way an admission of liability. Abbott stands by the safety of these products and the essential role they play in helping the medical community care for preterm infants,” Abbot said in a statement.
Abbott emphasized its products are recognized by the FDA, NIH, CDC, American Academy of Pediatrics, NEC Society (a non-profit organization focused on NEC prevention) and other medical professionals, and deemed as safe. The company also stated that there is no reliable scientific evidence its product causes NEC.
“While Abbott remains confident in the safety of these products and the science supporting them, the company believes these agreements are in its best long-term interest and represent a constructive step toward substantially resolving the overall litigation,” the company said.
Infant formula recalls spark industry concern and policy frameworks
The current settlement comes after years of contamination challenges across the infant formula industry that spurred regulatory action to improve safety and recall processes.
Separately, Abbott received multiple civil lawsuits after consumers complained of infant illness linked to powdered infant formula manufactured at its Sturgis, Mich., facility in 2022. Abbott initiated a voluntary recall after consumer complaints cited Cronobacter sakazakii and Salmonella Newport in infections.
Abbott halted production in the Sturgis plant in February 2022 after recalling certain Similac, Alimentum and EleCare powdered formulas as FDA investigated the claims. The closure sparked a nationwide infant formula shortage.
In 2025, infant formula manufacturer ByHeart recalled two batches of its powdered Whole Nutrition Infant Formula after it tested positive for Clostridium botulinum days after FDA issued a warning. While no deaths were reported, 23 infants were hospitalized across 13 states between Aug. 9, 2025 and Nov. 11, 2025.
By Nov. 11, 2025, ByHeart expanded the recall to span all batches of ByHeart Whole Nutrition Infant Formula cans and Anywhere Pack – its second recall in three years. ByHeart called the recall “an abundance of caution,” and it contested the presence of botulinum in its products.
The last four years of high-profile infant formula recalls and shortages prompted FDA to form its recall communication initiative called Operation Stork Speed in July 2025. While some industry stakeholders commended Stork Speed as an improvement in creating efficient and effective recall communications for infant formula, others raised concerns over the agency’s bandwidth.
In May 2026, FDA implemented its largest infant formula test to date across 300 formula samples sold in the US, including domestic and imported products. The agency’s testing is part of its ongoing oversight of infant formula under Operation Stork Speed through its Closer to Zero Initiative which intends to reduce contaminants in foods for infants and children. FDA’s infant formula testing initiative aims to establish levels of lead, arsenic, cadmium and mercury. The results found mostly trace contaminants, but the agency did not specify standards, enforcement or pre-market testing.
Critics point out that while the testing disclosed important data, more work must be done to ensure accountability, safety and transparency at the production level.
Whole milk infant formula launch face advertising scrutiny
On Aug. 31, Abbott launched Similac 360 Total Care Made With Whole Milk – a ready-to-feed liquid infant formula made with whole milk. The company claims the new formula is the closest resemblance to breast milk to date. The link to whole milk and breast milk sparked a sensitive advertising claim that the company challenged against competitor Kendal Nutricare Limited.
Abbott Laboratories (parent company to Abbott Nutrition) filed a complaint to the BBB National Programs’ National Advertising Division against Kendal for claims that its Kendamil infant formula with whole milk delivers superior nutritional benefits.
Although NAD substantiated Kendal’s core ingredient of using whole milk and its claim that it contributes naturally occurring milk fat to the formula, the watchdog recommends the company remove claims that competing formulas lose natural milk fat and nutrients. NAD states that Kendamil formula does not provide enough evidence to support the claim that their product delivers better nutritional benefits than other brands.
It also recommends Kendamil discontinue the claim “Creamy whole milk from European grass-fed cows, sourced from family farms. No skimming, no shortcuts, and no unnecessary ingredients.”
NAD concluded that Kendal remove claims its whole milk formula keeps natural fats closer to breast milk. It also recommends the brand remove its milk-fat comparison graphic which it said inaccurately depicts Kendamil’s composition and competing formulas. Although research shows that whole milk and breast milk share some compositional similarities, it’s not enough for brands to claim that whole milk can deliver comparable nutritional benefits, according to NAD.
Kendamil’s HMO blend claims to support bone health. However, NAD found the company’s evidence did not support product-specific claims and recommended its removal.
NAD also concluded that phrases like “Est. 1962″ or “60 years of experience” may mislead consumers into thinking the Kendamil brand or formula is more than 60 years old, when the statement reflects the company’s manufacturing heritage. NAD recommended clarifying or stopping those claims.
Kendal said it will comply with NAD’s recommendations following the decision.
