ByHeart is an American infant formula brand launched in 2022 as the first new FDA-registered infant formula manufacturer in the United States in more than 15 years. The formula is built around a patented protein blend with organic, grass-fed whole milk and no corn syrup, maltodextrin, or palm oil.
The brand conducted the largest clinical trial of a new infant formula in 25 years before launching. It earned Clean Label Project certifications and positioned itself as the closest formula to breast milk on the US market. In November 2025, ByHeart was linked to a national botulism outbreak that sickened 37 infants and triggered a federal recall.
This review covers what made ByHeart different from mainstream formulas, what the 2025 botulism outbreak revealed about the company’s actual facility conditions, what FDA inspections found at its plants, and what parents should do if they have ByHeart formula at home right now.
What Is ByHeart Formula?
ByHeart is an American infant formula company founded in 2016 that launched its first product in March 2022, becoming the first new FDA-registered infant formula manufacturer in the United States in more than 15 years. The company is headquartered in New York City.
And the scale of ambition here was real. ByHeart owns its entire manufacturing process across three states: Pennsylvania, Iowa, and Oregon. That end-to-end model was central to the brand’s promise of tighter quality control than companies relying on third-party manufacturers.
Here’s the founding idea: the company spent five years developing a formula built on current nutritional research, working with leading infant nutrition experts before a single product ever reached shelves.
Who Founded ByHeart?
ByHeart was founded in 2016 by siblings Mia Funt and Ron Belldegrun, motivated by dissatisfaction with the nutritional profile of existing infant formulas and a desire to build a product that more closely resembled human breast milk.
The founders didn’t rush it. In 2019, ByHeart acquired a production facility in Reading, Pennsylvania, giving the company direct manufacturing capability well before its public launch. The goal was ownership of every step from sourcing through packaging.
What Makes ByHeart Different From Other Formulas?
ByHeart differentiates itself through a patented protein blend that adds the two most abundant breast milk proteins — lactoferrin and alpha-lactalbumin — at levels closer to breast milk than conventional formulas. The formula uses organic, grass-fed whole milk as the primary ingredient rather than skim milk.
The product excludes a list of ingredients common in mainstream formulas. ByHeart contains no corn syrup, maltodextrin, soy, palm oil, GMOs, gluten, hexane-extracted DHA, or artificial growth hormones. The sole carbohydrate source is lactose.
What Are the Ingredients in ByHeart Formula?
ByHeart Whole Nutrition Infant Formula is built around organic, grass-fed whole milk and a patented protein blend containing lactoferrin, alpha-lactalbumin, and partially hydrolyzed proteins in an 80:20 whey-to-casein ratio similar to colostrum.
Key Ingredients in ByHeart Formula:
- Organic, grass-fed whole milk
- Lactoferrin (most abundant breast milk protein)
- Alpha-lactalbumin (second most abundant breast milk protein)
- Partially hydrolyzed proteins
- Lactose as sole carbohydrate
- DHA and ARA (essential fatty acids)
- Organic prebiotics
In 2021, ByHeart was the first U.S. infant formula to receive the Clean Label Project Purity Award, which screens products for more than 500 contaminants including heavy metals and pesticide residues. The certification added a layer of third-party credibility to the brand’s safety claims.
Does ByHeart Formula Contain Corn Syrup?
No. ByHeart explicitly excludes corn syrup, maltodextrin, soy, palm oil, and artificial growth hormones — ingredients commonly found in mainstream infant formulas. Lactose is the only carbohydrate source in the formula.
This ingredient positioning was central to ByHeart’s premium market appeal. Parents specifically sought ByHeart as an alternative to corn-syrup-containing formulas, often paying approximately $42 per can for the privilege.
How Does ByHeart Formula Work?
ByHeart is designed to work by providing a protein structure that mimics breast milk, with an 80:20 whey-to-casein ratio matching the protein balance of colostrum and partially hydrolyzed proteins that are pre-broken down for easier digestion.
The formula’s DHA and ARA fatty acids support brain and eye development. The organic prebiotic blend supports gut health and digestive comfort, which were key selling points for parents choosing a premium formula over mainstream options.
What Clinical Trials Has ByHeart Conducted?
ByHeart conducted what the company describes as the largest clinical trial of a new infant formula in 25 years before launching its product in 2022, evaluating the formula’s tolerability and nutritional outcomes in infants.
The trial results supported the product’s claims around digestive comfort and tolerability relative to conventional formulas. ByHeart used this data as a key marketing differentiator, positioning the formula as scientifically validated rather than simply reformulated.
What Do ByHeart Formula Reviews Say?
ByHeart built a strong initial reputation among parents seeking premium, clean-ingredient infant formula — attracting buyers specifically looking for a corn-syrup-free, breast-milk-inspired product with U.S.-based manufacturing.
Parent reviews prior to the 2025 botulism outbreak consistently praised the formula’s digestive tolerability, clean ingredient list, and the company’s transparency around sourcing. Many parents cited the clinical trial data as a key reason for their confidence in the product.
Here’s the thing: the November 2025 botulism outbreak changed everything. The discovery of safety failures at ByHeart facilities — including mold, insects, and rodent activity — shattered the trust parents had placed in the company’s premium safety claims.
What Are the Positive Experiences With ByHeart?
Parents who used ByHeart prior to the 2025 recall frequently reported strong digestive tolerance in their infants, attributing the formula’s partially hydrolyzed proteins and absence of corn syrup to reduced gas, fussiness, and feeding discomfort.
The Clean Label Project certifications also built confidence among health-conscious parents. The First 1,000 Day Promise Certification, which meets rigorous European standards, was cited as a major trust signal for parents choosing ByHeart over competing premium brands.
What Are the Common Complaints About ByHeart?
The primary complaint is the 2025 botulism outbreak. ByHeart was linked to a national outbreak of Clostridium botulinum that sickened 37 infants, with contamination traced to whole milk powder used in the formula. This is the most serious safety failure in the brand’s history.
ByHeart Pros and Cons:
- Pro: Patented protein blend closer to breast milk than mainstream formulas
- Pro: No corn syrup, soy, palm oil, or maltodextrin
- Pro: Clean Label Project Purity Award certified
- Pro: Organic, grass-fed whole milk base
- Con: Linked to 2025 botulism outbreak sickening 37 infants
- Con: FDA facility inspections found mold, insects, and rodent activity
- Con: Premium price of approximately $42 per can
- Con: Reading, PA facility now closed following the outbreak
Cost was a secondary complaint even before the recall. At approximately $42 per can, ByHeart is significantly more expensive than mainstream formula brands, placing it out of reach for cost-sensitive families.
Is ByHeart Formula Safe?
As of November 2025, ByHeart formula is the subject of a federal recall following a national botulism outbreak that sickened 37 infants with Clostridium botulinum contamination traced to whole milk powder used in the formula’s production. The formula is not safe to use at this time.
Pay attention to this: FDA inspections of ByHeart facilities found mold, dead insects, and leaking roof conditions at the Reading, Pennsylvania facility, which is now closed. The Iowa facility showed rodent activity, rusty surfaces, and Cronobacter sakazakii-positive environmental swabs.
What Happened With the ByHeart Botulism Outbreak?
In November 2025, ByHeart was linked to a national outbreak of Clostridium botulinum that sickened 37 infants across the United States, triggering a federal recall and full FDA investigation into the company’s supply chain and facilities.
FDA laboratory testing identified genetic matches between three samples: an unopened can of ByHeart formula, a clinical sample from a sick infant, and whole milk powder from a ByHeart supplier. The contaminated milk powder is the suspected root cause, though the specific supplier has not been publicly identified.
The outbreak prompted an international response. The UN and WHO’s Codex Committee on Food Hygiene called for a scientific risk assessment of botulism spores in all powdered infant formulas globally, citing the global implications of the incident.
What Did FDA Inspections Find at ByHeart Facilities?
FDA inspections of ByHeart facilities found mold, dead insects, and leaking roof conditions at the Reading, Pennsylvania plant, which has since been permanently closed, along with rodent activity, rusty surfaces, and Cronobacter sakazakii-positive swabs at the Iowa facility.
ByHeart was also cited for failing to establish adequate process controls to prevent microbial contamination. These findings directly contradicted the company’s marketed commitment to superior, end-to-end quality control and Clean Label Project certifications.
Is ByHeart Formula Legit?
ByHeart was a legitimate, FDA-registered manufacturer that held genuine certifications including the Clean Label Project Purity Award before the 2025 botulism outbreak revealed serious safety failures at its production facilities.
In plain English: there was a significant gap between the company’s marketed safety standards and the actual conditions at its plants. The FDA findings stand in direct contrast to the premium safety positioning that justified the $42 per can price tag.
Is ByHeart FDA Approved?
Yes. ByHeart is an FDA-registered infant formula manufacturer — the first new registration in the United States in more than 15 years when it launched in 2022. FDA registration is required for all infant formula sold in the US.
But here’s the part most people miss: FDA registration does not guarantee safety. The 2025 botulism outbreak revealed that ByHeart failed to maintain required process controls to prevent microbial contamination, despite holding FDA registration and multiple third-party certifications.
How Much Does ByHeart Formula Cost?
ByHeart formula costs approximately $42 per can — a premium price point positioned significantly above mainstream infant formula brands in the US market.
The premium pricing reflected the brand’s marketing around organic, grass-fed ingredients, clean-label certifications, and U.S.-based manufacturing. Parents chose ByHeart at that price specifically for its safety and quality claims. The 2025 outbreak called those claims into serious question.
Is ByHeart Formula Worth the Price?
Given the November 2025 recall, ByHeart formula is not currently available for purchase — the product is subject to a federal recall and its Reading, Pennsylvania production facility has been permanently closed.
Before the recall, the value proposition was built on clean ingredients and premium sourcing at $42 per can. That equation changed fundamentally. Parents paid a premium specifically for safety superiority — a claim the company could not support when inspections revealed the actual facility conditions.
Where Can You Buy ByHeart Formula?
ByHeart formula was sold at major US retailers including Target before the November 2025 recall; as of the recall, the product has been pulled from shelves and is not currently available for purchase through normal retail channels.
Parents who purchased ByHeart before the recall and have remaining product should contact ByHeart at hello@byheart.com or 1-833-429-4327 for refund inquiries. Adverse events can be reported through the FDA’s voluntary MedWatch reporting system.
Is ByHeart Formula Worth It?
As of November 2025, ByHeart formula is subject to a federal recall and is not safe to purchase or use — parents should contact their pediatrician immediately for guidance on alternative infant formula options.
The brand’s pre-recall reputation was built on genuine nutritional innovation: a patented breast-milk-inspired protein blend, clean ingredient standards, and meaningful clinical trial data. That foundation has been severely undermined by the 2025 botulism outbreak and the FDA facility findings.
Parents seeking alternatives should consult their pediatrician about FDA-registered formulas currently on the market. No formula purchase should be made without first confirming current recall status through FDA’s official safety alerts at FDA.gov.