Baby Formula

Whole Milk Infant Formula in 2026: The New Similac, the Recalls, and What Is Not Cow's Milk

Abbott's ready-to-feed whole-milk formula, what FDA found in the ByHeart and Nara powder investigations, and why a carton of milk is still not a substitute.

By TeachToddler Editorial Team · Published October 23, 2026 · Updated October 23, 2026

Quick answer: Whole-milk infant formula is a complete formula that uses milk fat in the recipe. It is not the same as pouring cow's milk into a bottle. CDC says cow's milk as a drink waits until 12 months. In 2026, Abbott launched a liquid ready-to-feed Similac made with whole milk. Two powdered whole-milk formulas, ByHeart and Nara Organics, were tied to separate infant botulism investigations that CDC has since declared over. Stop using any recalled can, and call a doctor right away if an infant who drank recalled formula develops constipation, a weak cry, poor feeding, or floppy muscles.

What parents should know

✓ Cow's milk from the carton is not infant formula. CDC says it is not a drink before 12 months.
✓ On August 31, 2026, Abbott launched Similac 360 Total Care Made With Whole Milk as a liquid ready-to-feed formula only.
✓ The ByHeart outbreak is closed at 48 illnesses, all hospitalized, and no deaths. CDC declared it over on February 26, 2026.
✓ The Nara Organics outbreak is closed at 4 confirmed illnesses, all hospitalized, and no deaths. CDC declared it over on August 27, 2026.
✓ FDA linked the two investigations through a shared organic whole-milk powder supply chain, not through "whole milk" as a category.

Whole-milk formula is not a glass of milk

Parents are seeing "whole milk" on more formula labels. That phrase means the formula uses milk fat, along with added oils and the vitamins and minerals an infant formula has to contain. It does not mean the product is the same as whole milk from the dairy case.

CDC says you can introduce pasteurized whole cow's milk at 12 months, and not before. Before that birthday, cow's milk may put a baby at risk for intestinal bleeding, has more protein and minerals than an infant's kidneys handle easily, and does not have the right mix of nutrients. Yogurt and cheese can come earlier. Drinking milk cannot. Toddler drinks are a third thing again: CDC says babies under 12 months should get infant formula made for infants, not a product labeled for toddlers.

Three products parents mix up. Only one belongs in a bottle before the first birthday.
What it is	Who it is for	What to remember
Whole cow's milk from the carton	A drink from 12 months	Not an infant formula, and not a bottle for a baby under 1.
Whole-milk infant formula	Infants, when formula is needed	A complete formula that includes milk fat. Still follow the label and any recall.
Toddler milk	Marketed for ages 12 months and up	CDC says toddlers do not need it to meet their nutrition needs. It often has added sugars.

What Abbott put on shelves on August 31

Abbott announced Similac 360 Total Care Made With Whole Milk on August 31, 2026. The company calls it the first commercially sterile, ready-to-feed liquid infant formula made with whole milk in the United States. It is sold only as a liquid, in 2, 8, and 32 fluid ounce bottles. Abbott said the 8 and 32 ounce sizes launched at a per-feeding price similar to powdered Similac 360 Total Care. It started at Target and Amazon, with Walmart and other stores to follow. The original Similac 360 powder and the original ready-to-feed liquid were not discontinued.

Abbott says this formula uses whole milk plus five human milk oligosaccharides, does not contain corn syrup or palm olein oil, and is made at Abbott's own U.S. plant. The company also describes it as Similac's closest formula to breast milk. That is a marketing description. No formula is breast milk. Breast milk remains the recommended way to feed an infant when it is available. Formula is the appropriate substitute when breastfeeding is not happening, in part or at all.

The liquid-only decision is the part that matters for safety, not the word "whole" on the label. Ready-to-feed liquid formula is commercially sterile. Powdered formula is not. Abbott says the heat step used for its liquid formulas is meant to eliminate microorganisms, including spores that can cause infant botulism. CDC's separate Cronobacter guidance is that a liquid formula is worth considering for babies younger than 2 months, babies born prematurely, and babies with weakened immune systems. That guidance is about powdered formula in general. It is not a finding that every whole-milk powder is unsafe.

A new formula is still a formula change: Switch because your clinician recommends it or because a product you were using was recalled, not because a label says whole milk. If you do switch, keep the old and new names written down for a week so you can tell a pediatrician what changed.

Two powdered formulas were investigated. The outbreaks are closed.

ByHeart and Nara Organics are both whole-milk powdered infant formulas, and both were investigated for infant botulism. CDC has declared both outbreaks over. Closed does not mean a recalled can became safe to use.

The ByHeart investigation began in November 2025. FDA and CDC concluded that ByHeart Whole Nutrition powdered infant formula was the source. As of the February 26, 2026 close-out, the count was 48 illnesses: 28 confirmed and 20 probable. All 48 infants were hospitalized. There were no deaths. The last illness onset was November 29, 2025. On June 3, 2026, FDA said inspections of ByHeart facilities found Clostridium botulinum in a powdered milk ingredient and did not find an additional cause inside those facilities. The root-cause work was still focused on ingredients.

The Nara investigation covered illnesses with onset from April through May 2026. CDC declared it over on August 27, 2026, with no new cases added after July 3. The count is 4 confirmed cases, from California, Pennsylvania, and Washington. All 4 infants were hospitalized and treated with BabyBIG. There were no deaths. CDC's July 6 update put the infants at about 2 to 5 months old at onset. Nara recalled every lot of its powdered whole-milk formula then on the market. The cans are 700 g (UPC 860013251901) and 400 g (UPC 860013251918). They had been sold at Target and on Nara's site.

FDA later reported that one clinical sample from an infant in the Nara investigation genetically matched a clinical sample from the ByHeart outbreak, a ByHeart powdered formula-base sample, and four unopened cans of ByHeart powder. The Nara lots linked to illnesses used milk from Organic West Milk that was spray-dried by Dairy Farms of America, the same suppliers tied to the ByHeart investigation. FDA said that points to a common source and that there was not yet enough evidence to say whether the milk was contaminated before drying or during drying. Nara said, at the time of its recall announcement, that its own formula had not tested positive. The warning for parents is the recall and the illnesses, not a claim that every whole-milk brand shares this supply chain.

Do not finish a recalled can: Stop using recalled ByHeart or Nara powder, including unopened cans. Do not donate it or give it away. Match the lot code on the bottom of a Nara can to the FDA recall notice. If an infant who consumed recalled formula has constipation, poor feeding, a weak or different cry, drooping eyelids, trouble swallowing, or floppy movements, get medical care immediately.

How to choose a formula after these headlines

Start with what your baby is already tolerating, unless that product was recalled or your pediatrician wants a change. A whole-milk fat blend is one recipe style. Kendamil and other whole-milk formulas were not named in these FDA outbreak notices. That is not a promise about any brand. It means the finding was a shared powder supply chain for the ByHeart and Nara lots, not a rule that milk fat itself causes botulism.

Use the label you have in the house. Ready-to-feed liquid is already mixed. Powder has to be prepared with the water volume on that label. Do not water formula down, and do not add extra powder to make it "more filling." If a baby is under 2 months, was born early, or has a weakened immune system, ask the pediatrician whether a liquid formula is the better fit, which is the Cronobacter question and not only a botulism question.

Our best baby formula guide compares the everyday options. The Kendamil and ByHeart comparison is the place for that specific matchup, and it should be read alongside the FDA outbreak page because the recall changed the answer. After the first birthday, the choice is usually pasteurized whole milk rather than a toddler formula. That handoff is covered in toddler milk versus whole milk.

Keep a record of what you actually fed

If a pediatrician, the formula company, or a health department asks what your baby drank, the useful details are the brand, the lot code, and the dates. Write the lot down when you open a can. A photo of the bottom of the can is enough.

The free Baby Formula Tracker app is a feeding log for iPhone. You can record which formula you used and how the bottles went. It does not diagnose botulism, check a recall, or replace the FDA notice or your pediatrician. If you are comparing a replacement after a recall, log the old formula and the new one separately so a week of gas or constipation is easier to describe accurately.

Frequently asked questions

Is whole milk infant formula just cow's milk?

No. It is an infant formula that includes milk fat. CDC says cow's milk as a drink should wait until 12 months because it does not meet an infant's nutrient needs and can stress the kidneys and gut.

Is the new Similac whole-milk formula part of the botulism recalls?

No. Similac 360 Total Care Made With Whole Milk is a different product. Abbott launched it on August 31, 2026, as a ready-to-feed liquid only. The 2025 and 2026 outbreak notices named ByHeart powder and Nara Organics powder.

Can I still use ByHeart or Nara formula if the outbreak is over?

Do not use a recalled can. CDC declared the ByHeart outbreak over on February 26, 2026, and the Nara outbreak over on August 27, 2026. An outbreak being over does not clear product that was recalled. Check the lot against the FDA recall pages.

Did FDA say every whole-milk formula is contaminated?

No. FDA connected the ByHeart and Nara investigations to a shared organic whole-milk powder supply chain, including Organic West Milk and Dairy Farms of America. Other whole-milk formulas were not named in those notices.

What are the signs of infant botulism?

Constipation, poor feeding, a weak or altered cry, drooping eyelids, trouble sucking or swallowing, loss of head control, and floppy movements. These illnesses in the investigations were treated in the hospital, including with BabyBIG. Get care immediately rather than watching the symptoms overnight.

Keep reading

Sources

This guide was checked against the current guidance below. Medical and safety recommendations can change; use the linked source and your child's clinician for decisions specific to your family.