According to a ByHeart release, ByHeart was notified by the FDA on November 7, 2025 of an estimated 83 cases of infant botulism that were reported nationwide since August 2025. Of these, the FDA also noted that 13 infants received ByHeart formula at some point. The FDA has not identified a direct link between any infant formula and these cases and there is no historical precedent of infant formula causing infant botulism. Botulism is extremely uncommon in dairy products or infant formula, and is naturally occurring in environmental sources like soil, select vegetables, and dust.
ByHeart announced today that, out of an abundance of caution, it has chosen to voluntarily recall two batches of ByHeart Whole Nutrition Infant Formula following notification from the U.S. Food and Drug Administration (FDA) of a broader ongoing investigation into a recent outbreak of infant botulism.
On November 8, 2025, ByHeart Inc. recalled two lots of Whole Nutrition Infant Formula:
• Lot: 206VABP/251261P2 (“Use by 01 Dec 2026”)
• Lot: 206VABP/251131P2 (“Use by 01 Dec 2026”)
ByHeart Whole Nutrition Infant Formula is available for sale online and at major retailers nationwide.
The FDA and CDC, in collaboration with the Infant Botulism Treatment and Prevention Program (IBTPP), and state and local partners, are investigating a multistate outbreak of 13 infant botulism illnesses from 10 states: Arizona, California (2), Illinois (2), Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas (2), Washington. Laboratory confirmation for some cases is ongoing. There are no deaths reported at this time. The IBTPP reported an increase in number of botulism type A infections among infants consuming ByHeart powdered infant formula from August 2025 to November 2025. All 13 cases included in this outbreak are reported to have consumed ByHeart- brand powdered infant formula. Officials in several states have collected leftover infant formula for testing. This testing is underway, and results are not yet available but expected in the coming weeks. State and local public health officials are interviewing caregivers about the foods infants were fed in the month before they got sick. All 13 (100%) reported feeding ByHeart Whole Nutrition infant formula.
FDA has been in contact with ByHeart and has recommended the firm conduct a voluntary recall due to the number of cases, severity of illness, and the strong epidemiological signal. Today, ByHeart, Inc. agreed to initiate a recall of the two lots of ByHeart Whole Nutrition infant formula (Lot: 206VABP/251261P2 and Lot: 206VABP/251131P2) that were reported to have been consumed by sick infants. FDA is continuing to work with the firm to ensure all potentially impacted products are removed from the market. FDA’s investigation is ongoing to determine the point of contamination and if any additional products are impacted.
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 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.