Health officials have announced another recall for ByHeart Whole Nutrition Infant Formula, this time after an outbreak of botulism in babies.
ByHeart Infant Formula has been linked to 13 suspected or confirmed cases of infant botulism in 10 states between mid-August and November 2025, according to the CDC Outbreak Investigation.
The states include Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, and Washington.
In the recall, ByHeart explained that there were “83 cases of infant botulism reported nationwide since August 2025. Of these, the FDA also noted that 13 infants received ByHeart formula at some point.”
ByHeart also emphasized that 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.”
Even so, ByHeart had it had agreed to proactively recall two lots of infant formula that were linked to all 13 reports of baby botulism, including:
- Lot: 206VABP, Batch Code: 251261P2, Use by: 01 Dec 2026
- Lot: 206VABP, Batch Code: 251131P2, Use by: 01 Dec 2026
- UPC: 5004496800
The lot code, batch code, and “Use By” date are on the bottom of the can. Click here for pictures.
Botulism can be deadly, and the FDA is urging caregivers to take action right away. Seek immediate health care if your child has consumed ByHeart Whole Nutrition Infant Formula and is showing signs and symptoms of infant botulism, which can take up to several weeks to develop.
The first signs of infant botulism can include constipation, poor feeding, loss of head control, difficulty swallowing, or decreased facial expression, which can progress to life-threatening breathing failure.
Parents should record the information on the bottom of the can before throwing it out. The FDA is urging parents to report this information if your baby gets sick. The symptoms may not start for up to 30 days after a baby is fed contaminated formula.
This is the second major recall for ByHeart Whole Nutrition Infant Formula, after a previous recall in 2022 due to a risk of cross-contamination with a dangerous bacteria called Cronobacter sakazakii in the facility where ByHeart baby formula was canned. No illnesses were reported.
Source: Outbreak Investigation of Infant Botulism: Infant Formula (November 2025)
