ByHeart infant formula was designed with a protein blend closer to breast milk than most conventional formulas, and a clinical trial showed real digestive benefits for infants. However, the brand faced a serious safety crisis: all ByHeart products were recalled in late 2025 after an outbreak of infant botulism linked to a contaminated milk powder ingredient. The CDC declared that outbreak over in February 2026, but the recall reshaped the conversation around this formula significantly.
Whether ByHeart is “good” depends on when you’re reading this and whether the product is back on shelves. Here’s what the evidence shows about both the formula’s design and what went wrong.
What Made ByHeart Different
ByHeart built its formula around a protein blend intended to mimic breast milk more closely than standard formulas. Most infant formulas use a basic whey-casein mix, but ByHeart’s version included alpha-lactalbumin (a key protein in mature breast milk), lactoferrin (an immune-supporting protein), and partially hydrolyzed whey, which is pre-broken-down to be easier on a baby’s stomach. The base is organic, grass-fed whole milk rather than the skim milk powder most brands rely on.
The fat blend is another notable difference. ByHeart uses organic high oleic sunflower oil, rapeseed oil, coconut oil, and sunflower oil. It contains no palm oil, which matters because palm oil in formula has been linked to harder stools and reduced fat absorption in some studies. Skipping it was a deliberate choice to support softer, more comfortable digestion.
The formula also includes galactooligosaccharides (GOS), a prebiotic fiber that feeds beneficial gut bacteria. Research on GOS in infant formula has shown it increases bifidobacteria (the dominant “good” bacteria in breastfed infants’ guts), lowers stool pH, and produces softer, more frequent stools, all markers that an infant’s digestive system is functioning more like that of a breastfed baby.
What the Clinical Trial Found
ByHeart funded a randomized clinical trial comparing its formula to a standard commercial formula. The results, published in the Journal of Pediatric Gastroenterology and Nutrition, showed several meaningful differences. Infants on ByHeart had significantly fewer spit-ups and softer stool consistency compared to the control group. Parents also reported better overall gastrointestinal tolerance.
Growth outcomes were particularly interesting. Babies on ByHeart gained weight and length at the same rate as those on the standard formula, but they did it while consuming less formula and less total protein. The researchers measured what they called “energetic efficiency,” finding that ByHeart infants were 14% more efficient at converting nutrition into weight gain and 13% more efficient for length gain. In practical terms, the babies grew just as well on less food, which the researchers suggested could reduce the metabolic burden of protein overfeeding that’s common with conventional formulas.
The trial did not measure sleep outcomes, despite ByHeart’s marketing sometimes implying sleep benefits. The digestive findings were solid, but they came from a single industry-funded study, not independent replication.
Certifications and Testing
Before the recall, ByHeart was the first infant formula in the U.S. to earn the Clean Label Project Purity Award. That certification involved screening for over 500 contaminants, including heavy metals, pesticides, and industrial and environmental toxins. It was ByHeart’s strongest third-party credential and a genuine differentiator in a market where most formulas haven’t undergone that level of independent contaminant testing.
It’s worth understanding what FDA oversight looks like for formula in general. The FDA does not approve infant formulas before they go to market. Manufacturers must submit a notification showing the product meets required nutritional and safety standards, but there’s no pre-market approval stamp. If a product fails to meet requirements after launch, the FDA can act to remove it.
The Botulism Outbreak and Full Recall
In late 2025, the FDA linked ByHeart formula to an outbreak of infant botulism, a rare but serious illness caused by bacterial toxins. The investigation traced the contamination to a milk powder ingredient. All ByHeart infant formula products were recalled, including every lot of cans and single-serve stick packs.
FDA inspections of ByHeart’s three manufacturing facilities (in Reading, Pennsylvania; Allerton, Iowa; and Portland, Oregon) revealed a mixed picture. The Portland facility received a clean bill, classified as “No Action Indicated.” The Iowa facility was cited for manufacturing practice deficiencies but classified as “Voluntary Action Indicated,” a less severe finding. The Reading, Pennsylvania plant, which ByHeart acquired in 2019, was the most troubled. It was classified as “Official Action Indicated,” the FDA’s most serious designation, citing manufacturing deficiencies. That facility hadn’t been in operation since September 2023, well before the outbreak.
The CDC declared the outbreak over in February 2026. At the time of the investigation, ByHeart said it had begun facility upgrades and was seeking $15 million to build an entirely new manufacturing plant.
The Price Factor
Even before the recall, ByHeart’s cost was a barrier for many families. At roughly $42 per can, it sat at the premium end of the formula market. That price reflected the organic ingredients, the proprietary protein blend, and a smaller-scale manufacturing operation. For families who could afford it and whose babies responded well, the digestive benefits shown in the clinical trial made the cost feel justified. For others, comparable benefits might come from other palm oil-free or partially hydrolyzed formulas at lower price points.
Where Things Stand Now
The formula’s design, with its breast milk-modeled protein blend, palm oil-free fat source, and prebiotic fiber, represented a genuinely thoughtful approach to infant nutrition. The clinical data on digestion and growth efficiency was promising. But the botulism outbreak exposed serious gaps in manufacturing quality control that can’t be separated from any assessment of the product. A well-designed formula only matters if it’s consistently safe to feed your baby.
If ByHeart returns to the market, the key question won’t be the ingredient list, which was always strong. It will be whether the company has rebuilt its manufacturing infrastructure to a standard that matches the quality of its formulation. Any parent considering ByHeart going forward should check the FDA’s infant formula page for current recall status and facility inspection results before purchasing.