An Update From Our Founders

Date: November 11, 2025

To our ByHeart family,

We are so sorry for the immense anxiety and fear that we have been causing you these past few days. As parents and as founders, that is the absolute last thing we would ever want to do.

We’re writing to you today to tell you that we have decided to voluntarily recall all ByHeart formula nationwide—this includes both our cans and our single-serve Anywhere Pack™ sticks. This decision was made to ensure your baby’s safety.

It’s important that you know that neither we, nor the FDA or CDC, have found Clostridium botulinum spores or toxins in any unopened can of ByHeart formula.

The decision to broaden our recall to all ByHeart products comes after a call with the FDA late last night, informing us that they found two more cases of infant botulism in babies that had also consumed ByHeart at some point. The FDA’s investigation into infant botulism in the U.S. is still ongoing, and we feel that there are still too many unanswered questions. Your baby’s safety is, and always will be, our biggest priority.

Upon learning about this outbreak on Friday evening, we immediately began conducting our own extensive testing on all ByHeart batches. Additionally, we are providing the FDA complete and unrestricted access to all of our facilities and products for their investigation, which has been done regularly at our owned facilities. We will share the results of our own testing as they become available.

At this moment, the most important thing for you to know is that all ByHeart product must be discarded. We know that switching formulas is not an easy process or decision. We have resources to help here.

We are so sorry, and are committed to doing anything we can to support you.

Our Parent Experience team is here to help with any of your questions—they are working 24/7. We are doing our best to reply to all of you in a timely manner, but we are a small team and may take a bit longer than our typical response times. If you think your child is experiencing symptoms of infant botulism, please seek medical attention immediately.

With love,

Mia Funt & Ron Belldegrun, Co-Founders of ByHeart

Important Voluntary Recall Information

We are expanding our voluntary recall to include all batches of ByHeart Whole Nutrition Infant Formula cans and Anywhere Pack™ nationwide. This action is being taken in close collaboration with the U.S. Food and Drug Administration (FDA), despite the fact that no unopened ByHeart product has tested positive for Clostridium botulinum spores or toxin.

This action underscores ByHeart’s core mission: protecting babies above all else.

Can UPC: 85004496800

Anywhere Pack™ UPC: 85004496802

What Consumers Should Do:

Consumers who have purchased ByHeart Whole Nutrition Infant Formula cans and Anywhere Pack™ should immediately discontinue use and dispose of the product.

First Published Date: November 10, 2025

An Open Letter to the U.S. Food & Drug Administration

First Published Date: November 9, 2025

An Update For Our ByHeart Family

First Published Date: November 8, 2025

An Update From Our Founders

Frequently Asked Questions

What are the symptoms of infant botulism?

Last Updated: November 8, 2025

Infant botulism is a rare but potentially fatal illness that presents a serious threat to the health of infants which occurs when Clostridium botulinum spores are ingested and colonize the intestinal tract, producing botulinum neurotoxins in the immature gut of infants. Affected infants can present with some or all of the following signs and symptoms: constipation, poor feeding, ptosis (drooping eyelid), sluggish pupils, low muscle tone, difficulty sucking and swallowing, weak or altered cry, generalized weakness, respiratory difficulty, and possibly respiratory arrest.

What should I do if my baby is experiencing symptoms related to infant botulism?

Last Updated: November 8, 2025

If your infant is experiencing symptoms related to infant botulism, contact your health care provider immediately. Additionally, please contact us at hello@byheart.com or call 1 (833) 429-4327.

To report an illness or adverse event to the FDA, you can:

1. Call an FDA Consumer Complaint Coordinator if you wish to speak directly to a person about your problem.

2. Complete an electronic Voluntary MedWatch form online.

3. Complete a paper Voluntary MedWatch form that can be mailed to the FDA.

Is my baby safe if they’ve already consumed formula from the batches affected by the voluntary recall?

Last Updated: November 8, 2025

As parents ourselves, we understand this concern this news may raise. To reiterate – The FDA has found no direct link to infant formula in its investigation, and infant formula has never been shown to cause infant botulism.

If your baby did consume formula from batches affected by this recall and appears to be experiencing symptoms related to infant botulism, contact your health care provider immediately. Additionally, please contact us at hello@byheart.com or call 1 (833) 429-4327.

To report an illness or adverse event to the FDA, you can:

1. Call an FDA Consumer Complaint Coordinator if you wish to speak directly to a person about your problem.

2. Complete an electronic Voluntary MedWatch form online.

3. Complete a paper Voluntary MedWatch form that can be mailed to the FDA.

How can I stay updated on this voluntary recall?

Last Updated: November 8, 2025

For the most recent up to date information, continue to check our site here. Any parents with questions please contact our experts at hello@byheart.com or call 1 (833) 429-4327.

More about infant botulism

Last Updated: November 10, 2025

What is infant botulism?

Infant botulism is a rare but serious illness caused by a toxin produced by the bacteria Clostridium botulinum. The bacteria are found naturally in the environment—in places like soil, dust, and some vegetables. International food safety authorities, such as the Codex Alimentarius Commission, have concluded that C. botulinum is not a risk in powdered infant formula. The International Commission on Microbiological Specifications for Foods recommended that powdered infant formulas and dairy-based ingredients for infant formulas not be tested for C. botulinum, and no U.S or global infant formula company is required to test for Clostridium botulinum.

Signs and symptoms of infant botulism can include: constipation, poor feeding, ptosis (drooping eyelid), sluggish pupils, low muscle tone, difficulty sucking and swallowing, weak or altered cry, generalized weakness, respiratory difficulty, and possibly respiratory arrest. If you’re concerned that your baby is experiencing any of these symptoms, please seek medical attention immediately.

Is botulism regularly tested for in formula?

International food safety authorities — including the Codex Alimentarius Commission and the International Commission on Microbiological Specifications for Foods — have determined that C. botulinum is not considered a hazard in powdered infant formula due to stringent hygiene practices in production and the extremely low prevalence of spores.

Routine testing for C. botulinum is not recommended; instead, manufacturers test for other indicators of hygiene and safety.

Have there been past outbreaks of infant botulism linked to formula?

No. There is no historical precedent or evidence of infant formula causing infant botulism.

Could a specific ingredient be the source or is it more likely a result of preparation?

There is no historical precedent of infant formula or dairy ingredients used in infant formula causing infant botulism.

What should I do if my baby is experiencing symptoms related to infant botulism?

If your infant is experiencing symptoms related to infant botulism, contact your health care provider immediately. Additionally, please contact us at hello@byheart.com or call 1 (833) 429-4327.

To report an illness or adverse event to the FDA, you can:

1. Call an FDA Consumer Complaint Coordinator if you wish to speak directly to a person about your problem.

2. Complete an electronic Voluntary MedWatch form online.

3. Complete a paper Voluntary MedWatch form that can be mailed to the FDA.

Can I trust other infant formulas are safe to feed my baby?

We do not have detailed information at this time whether other infant formula brands have been impacted by the FDA’s investigation. The FDA is the appropriate source for updates on other infant formula brands.