First Published Date: November 24, 2025

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:

1. Our Updated Refund Policy (As of November 24, 2025)

2. Contaminated Product

3. 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.
  

For customers who purchased ByHeart products at Retail stores, that retailer will handle your refund. We encourage you to contact them directly for details about their refund policy and to process your refund for ByHeart infant formula.

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 and Ron