Voluntary Recall 2025
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
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 ca
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
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 imma
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 [email protected] or call 1 (833) 429-4327. To report an illness or adverse event to the FDA, you ca
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 f
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. Batch Code: 251261P2, Use by: 01 Dec 2026. Batch Code: 251131P2, Use by: 01 Dec 2026. Our Parent Expe
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 batc
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 Parent Experience Team at [email protected] or call 1 (833) 429-4327.
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
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
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.
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.