Abbott is launching the first and only ready-to-feed liquid infant formula made with whole milk available in the United States, the nation’s largest formula manufacturer announced Monday. The new formula is called Similac 360 Total Care Made With Whole Milk.
“Parents have been asking for more whole milk options, and we wanted to give them something they couldn’t get anywhere else,” Misha Pardubicka-Jenkins, Abbott’s U.S. vice president and general manager for pediatric nutrition, said in a press release.
“We decided on a liquid-only approach to give families the benefits of whole milk, the convenience of a formula that’s ready when baby is, and the reassurance that comes with a commercially sterile liquid formula,” Pardubicka-Jenkins said.
How does ready-to-feed compare to powdered infant formula?
Both liquid and powdered infant formulas sold in the U.S. meet strict nutrition standards and are considered very safe for babies.
While both undergo steps in manufacturing to eliminate potentially harmful microorganisms, liquid infant formula in ready-to-feed bottles undergoes an additional sterility step to become commercially sterile.
This sterilization step helps eliminate spores of microorganisms, including Clostridium spores that can cause infant botulism, Abbott said in a press release.
The Centers for Disease Control and Prevention (CDC) says that extra precautions should be taken to ensure powdered formula is properly prepared for infants who are less than two months old, born premature, or have weakened immune systems and parents can consider the use of sterile liquid formula in these populations.
While illness outbreaks from manufactured infant formulas are rare, in recent years there have been multiple powder infant formula recalls related to contamination concerns from microorganisms.
In 2022, Abbott recalled several infant formulas after four infants became sick with Cronobacter infections whose parents say they consumed Abbott formula made at their facility in Sturgis, Mich. Two of those infants died, according to the FDA.
While the CDC says testing did not match the Cronobacter samples taken from the Sturgis facility to the two patient samples of Cronobacter available, the contamination concerns contributed to a national infant formula shortage after the facility in Sturgis was temporarily closed during the outbreak investigation.
In a 2022 statement, Abbott said the outbreak investigation “did not find any definitive link between the company’s products and illnesses in children. No retained samples of recalled products tested positive for Cronobacter. And, in all four cases, unopened containers of formula in the infant homes tested negative for Cronobacter skazakii.”
Abbott added they are “committed to working with regulators, independent experts and others to set a new standard in infant formula safety and quality.”
In 2025 and 2026, there have been two infant botulism outbreaks linked to organic whole-milk infant powdered formula made by Nara Organics and ByHeart, the first known botulism outbreaks ever linked to infant formula in the U.S., the FDA said.
The CDC has now declared both outbreaks over. Testing during the outbreak investigations found both outbreaks linked to organic whole milk supplied by Organic West Milk that was spray-dried by Dairy Farmers of America, the Food and Drug Administration said on Thursday.
“Any illness involving infants is deeply concerning, and our thoughts are with the families impacted by the ByHeart and Nara infant formula outbreaks,” Dairy Farmers of America said in a statement to ABC News, in part. “DFA is no longer processing milk from, or for, Organic West Milk, the company that owned the raw organic milk that was turned into powder and that sold the organic milk powder to ByHeart and Nara Organics.”
“FDA has not concluded that any contamination originated at Dairy Farmers of America’s Fallon, Nevada facility,” the statement added.
Organic West Milk did not immediately respond to an ABC News request for comment.
The FDA continues to investigate the root cause of botulism linked to these products and their post-outbreak response to help prevent future illnesses. Both of these formulas have been recalled and should not still be on store shelves.
On Thursday, Nara Organics posted an update on their website, stating they are no longer sourcing from US dairy. “Our plan is to bring Nara infant formula back to families with EU dairy and rigorous C. Botulinum testing protocols in place,” the update said.
ByHeart also posted a statement on its website describing the mitigation measures they are taking, including identifying a new supplier and enhancing testing.
“What we have learned has given us pivotal insights to inform our path forward. We have always been proud of our rigorous standards, and now we are making them even stronger, reflecting new knowledge in the science of safety. We are working with the FDA on the safe resumption of infant formula production, and these are the immediate steps we are taking,” ByHeart said.
Another difference is that ready-to-feed infant formula is often more costly than powdered forms.
Abbott said they are making the price-per-feed of the 8- and 32-fluid-ounce bottles of their new ready-to-feed formula made with whole milk more comparable to the price-per-feed of their other Similac 360 powdered infant formulas.
How does formula with whole milk compare to other options?
There are now several formulas available in the U.S. that use whole milk.
“Historically, most commercial infant formulas have used a skim animal milk as their protein base and a vegetable oil blend rich in essential fatty acids for their fat content,” Dr. Ari Brown, a board-certified pediatrician based in Austin, Texas and author of Baby 411, told ABC News.
When counseling parents on how to choose the right one for their baby, Brown said that every family and baby’s needs are different based on the price they can afford and preferences.
“Today, some infant formulas utilize whole animal milk because it contains an ingredient called MFGM (milk fat globule membrane) -- MFGM is found in human and other animal milks,” Brown said. “While it is not clear that whole milk-based formulas (or other premium ingredients) are truly superior, formula manufacturers try to meet the demand. Future studies are certainly needed to see if there are true benefits for the additional cost.”
Infant formula made with whole cow’s milk still requires added vegetable oils to closely match what’s found in breast milk.
“One key point here: even infant formulas that use whole animal milk still add vegetable oil blends to match the essential fatty acids found in breast milk. It’s not either/or for the fat content; it’s both,” Brown said.
“Since there are so many infant formulas on the market, it boils down to three important questions: What does your baby like? What do you like? And what does your wallet like? These priorities may lead to different answers,” Brown added.
“While it is critical for the FDA to continue their work to ensure that nutrition standards for infant formula are up to date, it is important for caregivers to know that no evidence suggests a nutritional benefit to infant formula made with whole milk as compared to other fat sources,” Ali Hard, director of public policy for the nonprofit National WIC Association, told ABC News, adding that the organization “provides education and support for breastfeeding and all forms of infant feeding.”
Parents should still talk to their pediatrician when deciding what formula is right for their baby or if they are experiencing any feeding concerns.
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