Amid the rising incidence of infant botulism, ByHeart on Tuesday voluntarily issued a nationwide recall of Whole Nutrition infant formula — including cans and single-serve Anywhere Packs.
The development comes as several infants in 12 states have fallen ill since August.
Although no deaths have been reported so far, federal health officials said more cases are pending.
“We are expanding our voluntary recall to include all lots of ByHeart Whole Nutrition Infant Formula and Anywhere Pack™ cans nationwide. This action is being taken in close cooperation with the US Food and Drug Administration (FDA), despite the fact that no unopened ByHeart product has tested positive for Clostridium botulinum spores or toxin,” the company said.
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Product Details for Voluntary Recall:
The voluntary recall covers two lots:
— Batch code: 251261P2, Use by: December 1, 2026
— Batch code: 251131P2, Use by: December 1, 2026
— Anywhere Pack™ UPC: 85004496802
Where to find the batch code?
You can find the batch code and consumption on the bottom of the can.
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Are other ByHeart products affected?
No other batches of ByHeart are affected by this voluntary recall.
What should consumers do?
The company advised that consumers who purchased the product immediately stop using it and dispose of the product.
Will Byheart replace cans?
Yes, ByHeart will replace cans. According to the FDA, if you have discarded any formula from the following lots, ByHeart will replace those cans free of charge.
ByHeart co-founders say…
“We are writing today to tell you that we have decided to voluntarily recall all ByHeart products nationwide – this includes both our cans and our single-use Anywhere Pack™ sticks. This decision was made to ensure the safety of your baby. It is important that you know that neither we nor the FDA or CDC have found Clostridium botulinum under any ByHeartfoum toxin spores or corrodes in any ByHeart infant formula Mia Funt and Ron Belldegrun in a statement on the website.
They said the decision to expand our recall to all ByHeart products comes after a call with the FDA late last night, where they informed us they found two additional cases of infant botulism in children who also consumed ByHeart at some point.
The founders also insisted that the most important thing people should know is that all ByHeart product must be disposed of.
The company added that the Parent Experience team is here to help with any questions you may have.
What did the FDA say?
— The FDA has an ongoing investigation into infant botulism among children in the US
— The FDA has not found a direct link between any infant formula and these cases, and there is no historical precedent for infant formula causing botulism in infants.
— ByHeart is taking a proactive step to remove any potential risk from the market and ensure the highest level of safety for infants.
— On November 7, 2025, ByHeart was notified by the FDA of an estimated 83 cases of infant botulism reported nationwide since August 2025. Of those, the FDA also noted that 13 infants received ByHeart at some point.
— The FDA has not found a direct link between any infant formula and these cases, and there is no historical precedent for infant formula causing botulism in infants.
What is infant botulism?
Infant botulism is a rare but potentially fatal disease that poses a serious threat to the health of infants. However, it is quite rare.
According to the WHO, this is an intoxication usually caused by the ingestion of strong neurotoxins, botulinum toxins, which are formed in contaminated food. Botulism is not transmitted from person to person.
