Every lot of ByHeart Whole Nutrition Infant Formula remains under recall, and the reason that still matters in August is printed on the cans themselves. The two lots recalled first carried use-by dates of December 1, 2026, and the recall was later broadened to cover every batch code and use-by date the company had on the market. A container sitting in a pantry today may still read as perfectly good.
The recall followed a multistate outbreak of infant botulism. The Centers for Disease Control and Prevention closed the outbreak investigation earlier this year, reporting 28 confirmed and 20 probable cases, totaling 48 across 17 states. All 48 infants were hospitalized and treated, and no deaths were reported. Public health officials reached those figures after reviewing the medical records of 51 infants initially included and excluding three who were ultimately diagnosed with other illnesses. Epidemiologic and laboratory data showed the formula was contaminated with Clostridium botulinum and made infants sick. The investigation into how the bacterium reached the product remains open.
For most households, this is not a current shopping decision, because the product should no longer be for sale. It is a cabinet decision. Infant formula is bought in bulk, stored for months, passed between family members, and kept for a second baby, and its shelf life outlasts the news cycle that announced the recall.
A Recall That Covers Every Lot, Not Selected Ones
The scope here is unusually broad. According to the FDA recall notice, the recall covers all batch codes and use-by dates for the 24-ounce can of ByHeart Whole Nutrition Infant Formula and the 0.60-ounce Anywhere Pack, which contains 14 packets per package.
That removes the usual consumer task. There is no lot code to match and no expiration window to check. Any ByHeart Whole Nutrition Infant Formula in a home is covered. The initial recall in early November 2025 named only two lots, both with a use-by date of December 1, 2026, and one state health department listed those codes before the recall was expanded days later.
FDA's guidance to families holding the product is specific and slightly unusual. Rather than discarding it immediately, the agency asks consumers to photograph or record the information on the bottom of the package, keep the container in a safe place, and label it clearly as "Do Not Use," because a state health department may want to collect it for testing if a child develops symptoms. If the child has no symptoms after 30 days, the containers can be thrown out. FDA also advises washing any items and surfaces that may have touched the formula with hot soapy water or in a dishwasher.
The product was sold online and in stores at major retailers nationwide. Removing it proved difficult: the FDA sent warning letters to four major retailers in December 2025 for failing to pull recalled formula from shelves and issued a public reminder to industry about recall obligations. The agency has noted that the product may still appear on online marketplaces and that consumers should not buy it even if they find it listed. FDA has also said ByHeart products accounted for roughly 1 percent of U.S. infant formula sales and that the recall did not create shortage concerns.
Constipation Is the First Sign, Not the Last One
Infant botulism is not ordinary food poisoning, and the difference is the reason this recall carries more weight than a typical grocery alert.
It occurs when a baby swallows Clostridium botulinum spores that then grow in the intestine and produce a toxin. The illness is neurological. CDC and FDA describe the typical progression as beginning with constipation, poor feeding, loss of head control, and difficulty swallowing, which can advance to difficulty breathing and respiratory arrest. Drooping eyelids, sluggish pupils, low muscle tone, difficulty sucking, and a weak or altered cry also appear on the list.
Two features make it easy to miss. Symptoms are diagnosed clinically rather than by a quick test, and the FDA notes they can take several weeks to develop after the formula is consumed. A parent looking for a sudden stomach illness within hours, the pattern most people associate with contaminated food, is watching for the wrong thing.
Constipation in an infant is common and usually benign. What distinguishes concern is the combination: a baby who becomes constipated and also feeds poorly, seems unusually floppy, has weak head control, a weaker cry, drooping eyelids, or reduced facial expression. Any infant showing those signs needs immediate medical attention, and the parent should tell the clinician about formula exposure. Difficulty breathing is an emergency.
Infant botulism is treatable. Every infant in this outbreak received BabyBIG, the antitoxin distributed through the Infant Botulism Treatment and Prevention Program run by the California Department of Public Health, and all of them survived. Prompt care is the operative point, which is why recognizing the early pattern matters more than memorizing the recall details.
The Supply Chain Question That Is Still Open
The investigation has moved away from the manufacturing plant and toward an ingredient.
According to the FDA's outbreak investigation page, the agency completed on-site inspections of ByHeart facilities and identified Clostridium botulinum in a powdered milk ingredient, but found no additional factors within those facilities that could explain the cause. Whole-genome sequencing tied the bacterium in the finished formula to isolates from organic whole milk powder and to a clinical isolate from a sick infant. Two of those milk powder isolates were collected by the FDA at Dairy Farmers of America, the processor for Organic West Milk, which supplies ByHeart.
Even so, sequencing has identified 17 different strains of the bacterium across patient samples, finished products, and ingredients, and the FDA has not determined a root cause. This is the first documented outbreak of botulism in the United States attributed to contaminated infant formula, and the agency has said that the differences between spore-forming bacteria such as Clostridium botulinum and organisms like Salmonella are shaping its response. Updates now run through the agency's post-outbreak response activities page.
That unresolved ingredient question is why the story isn't finished. It is the same structural situation behind the moringa powder recalls that MedicalDaily has followed: closing an outbreak count did not address the underlying ingredient, and recalled products kept surfacing with long shelf lives.
The households most affected are narrow and identifiable: families with infants under one year who used this brand, and anyone who received formula secondhand, through a buy nothing group, a hospital discharge bag, a relative, or a mutual aid network, where recall notices rarely follow the product.
Families needing replacement formula should not dilute their existing formula or make substitutes at home, both of which are dangerous for infants. Diluting formula to stretch a supply can cause dangerous drops in sodium levels, and homemade recipes circulating online do not meet infant nutritional requirements. Pediatric offices, WIC agencies, and local health departments can help identify an appropriate alternative, and WIC participants can ask their agency about substituting a covered brand, since state agencies can generally authorize a substitution when a contract brand is recalled.
Anyone whose infant was treated for botulism should keep medical records and product information together, since that documentation links an individual illness to an outbreak investigation. Families who bought the formula can contact the company or the retailer about a refund rather than absorbing the loss.
No timeline for the root cause finding has been published. MedicalDaily will report the outcome of the ingredient investigation and any expansion involving other products made with the same milk powder.
Key Questions Answered
Which products are recalled? All ByHeart Whole Nutrition Infant Formula, covering every batch code and use-by date for both the 24-ounce cans and the 0.60 ounce Anywhere Pack sticks. There is no lot code to check.
Why does this still matter now? The lots recalled first carried use-by dates of December 1, 2026, so containers in homes can still appear current, and the formula is commonly stored for months or shared between families.
What should someone do with a container they find? Do not use it. FDA asks consumers to photograph or record the information on the bottom of the package and keep the container labeled do not use, in case a health department needs it for testing.
What are the symptoms in a baby? Constipation, poor feeding, loss of head control, and difficulty swallowing, which can progress to difficulty breathing. Symptoms can take weeks to appear after the formula was consumed.
How many infants were affected? The investigation closed with 48 cases, 28 confirmed and 20 probable, across 17 states. All were hospitalized and treated with the antitoxin, and none died.
Has the cause been identified? Not fully. FDA found the bacterium in a powdered milk ingredient but no additional explanatory factors at ByHeart facilities, and sequencing has turned up 17 different strains. No root cause has been determined.
Where can a family get replacement formula? Ask a pediatric office, a local WIC agency, or a health department. Never dilute the formula or make a homemade substitute.
