Why is ByHeart issuing a voluntary recall?
In response to a broader FDA investigation of infant botulism in babies across the U.S, and out of an abundance of caution, we have decided to initiate a voluntary recall of two batches of ByHeart Whole Nutrition Infant Formula.
ByHeart was notified by the FDA that an estimated 83 cases of infant botulism were reported nationwide since August 2025. Of these, 13 babies had received ByHeart formula at some point.
However, the FDA has found no direct link to infant formula in its investigation and no testing conducted by ByHeart or the FDA has confirmed the presence of Clostridium botulinum spores or toxins related to infant botulism in any ByHeart product. Importantly, infant formula has never been known to cause infant botulism.
What batches of ByHeart formula are affected by the voluntary recall?
Out of an abundance of caution, we are voluntarily recalling two batches of ByHeart Whole Nutrition Infant Formula. The affected batches pertain to our Whole Nutrition Infant Formula cans only, not our Anywhere Packs. To locate the batch code, you can find it on the bottom of the can.
Batch Code: 251261P2, Use by: 01 Dec 2026
Batch Code: 251131P2, Use by: 01 Dec 2026
These batches were distributed primarily in July and August, and could have been purchased through one of our retailers in-store or online, or Amazon. No other ByHeart batches are affected.
What should I do if I have purchased formula from the recalled batches?
Consumers should immediately discontinue use and dispose of the product. If you have discarded formula from the recalled batches, ByHeart will offer replacement cans at no cost and ship it straight to you.
Please contact our Parent Experience team at hello@byheart.com or call 1 (833) 429-4327 for more information.
What are the symptoms of infant botulism?
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?
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?
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.
Will I be refunded or reimbursed for products affected by the voluntary recall?
If you’ve purchased ByHeart formula from the affected batch codes below, ByHeart will offer replacement cans at no cost and ship it straight to you.
Our Parent Experience team is here to support you with anything you need—please email hello@byheart.com or call 1 (833) 429-4327 for support or questions.
Batch Code: 251261P2, Use by: 01 Dec 2026
Batch Code: 251131P2, Use by: 01 Dec 2026
Are other batches of ByHeart’s formula safe to feed my baby?
Yes. We, along with our own families, friends, and team members, use ByHeart every day — and continue to do so. We have the utmost confidence in our product, our safety systems, and the people behind them. This voluntary recall fully removes the batches from circulation, ensuring that ByHeart formula currently available is safe.
How can I stay updated on this voluntary recall?
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
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 have concluded that C. botulinum is not a risk in powdered infant formula because of strict hygiene controls and the very low chance of spores being present.
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. The FDA has not identified a direct link between any infant formula and these cases.
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.