Additional updates from our founders.
Dear parents,
We’re listening to the questions you’ve been sharing, and we want you to know that we hear you. Again, we want to express how sorry we are for the anxiety and fear you’ve been facing, and as we navigate this moment, we are committed to doing it with as much heart, transparency, and integrity as possible.
The updates we’re sharing today reflect the progress we’ve been making and provide the clarity you deserve. Additionally, we’ve expanded our FAQ section to include answers to new questions we’ve received from families. The latest information can be found on ByHeart.com.
This letter includes important updates on the following:
- Our Updated Refund Policy (As of November 24, 2025)
- Contaminated Product
- Reports of ByHeart Formula Found at Retail Locations
Our Updated Refund Policy
As of November 24, 2025
ByHeart will now be able to provide a full refund for all products purchased on ByHeart.com on or after August 1, 2025. This is a change to our previous policy, as we work to better support families during this time.
This refund approach is guided by the most complete data available from FDA identifying the first infant in the outbreak on August 9, 2025, despite the initial notification to ByHeart on November 7, 2025.
How to receive your refund:
- All customers are eligible for a full refund for all ByHeart.com purchases placed on or after August 1, 2025. Please call us at 866-201-9069 and our team will assist you, 24/7.
- Once you speak to our team, you should expect to receive funds within 5-7 business days.
Contaminated Product
As soon as we learned from FDA of the infant botulism outbreak, we immediately partnered with IEH Laboratories & Consulting Group, a global leader in Food Safety testing, to test un-opened cans of ByHeart product, and conducted a nationwide recall. We tested 36 samples from three lots and, as shared on November 19th, we received positive test results for Clostridium botulinum Type A in five of the 36 samples across all three lots. Based on these results, we cannot rule out the risk that all ByHeart formula across all product lots may have been contaminated.
We continue to be focused on finding the root cause, through a rigorous audit of every step of our product development chain, from suppliers and raw ingredients, through to packaging and transportation. This includes testing more product samples.
We want to reaffirm the critical direction for parents and caregivers to stop using ByHeart formula immediately. We continue to strongly recommend monitoring for symptoms of infant botulism and to contact a medical professional immediately if your child develops symptoms.
- According to the American Academy of Pediatrics, the sign of Infant Botulism appears at an estimated 3 to 30 days from the time of consumption of the Clostridium botulinum bacteria.
- Symptoms often begin with constipation followed by difficulty feeding (sucking and swallowing), a weak and altered cry, diminished facial expression, droopy eyelids, loss of head control, and lethargy.
To report an illness or adverse event, you can: Call an FDA Consumer Complaint Coordinator if you wish to speak directly to a person about your problem; Complete an electronic Voluntary MedWatch form online; Complete a paper Voluntary MedWatch form that can be mailed to FDA.
Reports of ByHeart Formula Found at Retail Locations
On November 11, we conducted a full recall of all ByHeart cans and Anywhere Packs across ByHeart.com, Amazon and retailers nationwide. As part of our safety standards, and in alignment with regulatory requirements, we notified all retail partners to remove all ByHeart formula from their shelves, and they have confirmed communication has been sent to stores. FDA has also shared notifications with retailers.
Additionally, based on Consumer Product Recall Best Practices, there are safeguards in place to ensure that purchases of ByHeart infant formula cannot be completed if product is still on shelves and is scanned at check out systems.
We hope these updates provide clarity and serve as a helpful resource. If any questions come up, please reach out. Our team is here 24/7, fully dedicated to helping you and your family.
With love,
Mia & Ron
We’re here with support—24/7.
Call 866-201-9069
As parents ourselves, we understand how excruciating this recall has been. You deserve support, and our Parent Experience team is here to provide it—around the clock. You can speak with a person live, or leave your number and we’ll call you back.
For more support, visit our FAQs.
Our patented protein blend gets closest to breast milk.
This proprietary blend combines:
And unlike other formulas, we have it at actual breast milk levels! Bonus: It contains tryptophan—which has been shown to help babies fall asleep faster.
Alpha-lac
The #1 protein found in breast milk (and we have it at actual breast milk levels).
The protein in this early breast milk or “liquid gold” aids in iron absorption (which is a critical mineral for baby’s development).
Lactoferrin
The #1 protein found in colostrum that supports gut and immune health.
Partially hydrolyzed proteins paired with nutritious whole proteins make for a blend that’s also gentle on tummies.
Partially hydrolyzed proteins
These broken down proteins are easy to digest (which = happy tummies).
Our benefits aren’t just claimed. They’re clinically proven.
We ran one of the largest clinical trials for infant formula in 25 years—including 311 babies over 6 months. We’re also the only new brand to add a comparison to breast milk. All this allows us to understand our closeness to nature’s first recipe and all of its magical benefits.
Shop Our Infant Formula- Easy digestion
- LESS SPITUP*
- SOFTER POOPS*
- more efficient weight gain*
- Plus, our formula also supports: Brain & eye development, immune health and gut health.
*vs. a leading infant formula
We never skim on nutritious fats. Breast milk doesn’t skim the fat, so why would we? ByHeart is made with organic, grass-fed whole milk (not skim).
For Brain Development
Whole milk has delicious, nourishing fats like naturally-occurring MFGM—a complex blend of fats and proteins also found in breast milk. MFGM is crucial for baby’s brain development and growth (and has also been associated with a healthy microbiome).
For Easy Digestion
Whole milk has easy-to-absorb fatty acids which helps keep baby’s poops softer.
For Immune Support
Whole milk has 3.5x times the amount of beta-carotene as skim, which converts into Vitamin A—an essential vitamin for a strong immune system.
To make a better formula, you have to change how you everything about formula.
Our mission is to make the best formula on earth. We believe formula is the most important food for the most important people. And we’ve built our company to deliver on that belief, in every way.
Babies and their parents love ByHeart.
I switched my daughter from exclusively breastfeeding to combo feeding with this formula and it has been such a great switch. It was super easy to acclimate her to the formula.”
Ashley, Jan 2024
With ByHeart, I don’t feel like I’m having to compromise with her nutrition. She’s a happy, healthy, thriving little baby and she LOVES her ByHeart bottles!”
Alexis, Jan 2024
I tell all my patients who are considering changing to formula to look into the ingredients, small batch production, and benefits of ByHeart!”
Lauren, Feb 2024
I love your formula for my little guy! I wanted desperately to breast feed, when demands of life got too hard and I couldn't do it, I was just crushed. This formula makes me feel GOOD about what I'm giving my son!”
Bailey, May 2024
My goal was originally to solely breastfeed my baby for at least 6 months, but my supply dwindled earlier than expected. Then I found ByHeart which has whole milk instead of skim milk and it worked much better for him.”
Myrna, Jan 2024
Openhearted Initiative
Because there’s no such thing as other people’s babies.
Every parent who purchases a Feeding Plan automatically contributes to OpenHearted—our donation program in partnership with Baby2Baby. Together, we work with local organizations to get infant formula, nutrition education, and family support to those who need it most. Our goal? Donate 5 million feeds in 5 years.
Some exciting news for the formula industry.
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