Federal and state officials are investigating an outbreak of infant botulism caused by a ByHeart brand powder formula.
As of November 8, there were 13 confirmed patients in 10 states: Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas and Washington. No deaths have been reported yet.
The Food and Drug Administration contacted the company and recommended a recall. The company agreed and recalled 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.
“Infant botulism is a very rare disease that occurs when children inhale or ingest spores of the toxin-producing bacteria that cause infant botulism, leading to progressive muscle weakness, including breathing problems, if not treated promptly.” said Dr. Erica Pan, CDPH director and state health officer. “We have tested a sample of the specific infant formula associated with these cases and preliminary tests were positive. We urge parents to immediately stop using ByHeart formula.”
“Botulism, especially in children, can be severe and even fatal,” said Bill Marler, managing partner of Marler Clark, Inc., P.S., a food safety law firm. “This is the first time I've seen botulism in a dried powder product. The fact that it is intended for consumption by infants should be of concern to everyone,” Marler added.
The FDA's investigation is being assisted by state health departments and the Infant Botulism Treatment and Prevention Program (IBTPP).
The California Department of Public Health IBTPP reported an increase in type A botulism infections among infants consuming ByHeart powdered infant formula from August 2025 to November 2025. All 13 patients included in this outbreak were reported to have consumed ByHeart brand powdered infant formula. Officials in several states have collected leftover baby food for testing. This testing is ongoing and results are not yet available but are expected in the coming weeks.
There are concerns that consumers may have unused portions of the recalled formula in their homes due to its long shelf life, which is extended to 2026. Consumers can identify the recalled formula by looking for the following codes on the bottom of the product cans:
ByHeart Whole Nutrition Infant Formula:
- Lot: 206VABP/251261P2 (“Use until December 1, 2026”)
- Lot: 206VABP/251131P2 (“Use until December 1, 2026”)
ByHeart Whole Nutrition infant formulas account for an estimated less than 1 percent of all infant formulas sold in the United States, and this outbreak is not creating formula shortage issues for parents and caregivers. The formula is available in stores nationwide and online.
Most infants with infant botulism initially develop constipation, poor feeding, loss of head control, and difficulty swallowing, which may progress to difficulty breathing and respiratory arrest. Symptoms of infant botulism, which is diagnosed clinically, may develop several weeks after ingestion of formula.
Consumers should not use the recalled ByHeart Whole Nutrition infant formula and should discard the product immediately. If your baby experiences symptoms after taking ByHeart Whole Nutrition infant formula and you still have the formula at home, write the information on the bottom of the package before throwing it away.
Botulism can be fatal and you should take action immediately. If your baby has been using ByHeart Whole Nutrition infant formula and is experiencing signs and symptoms cases of botulism such as poor diet, loss of head control, difficulty swallowing, or decreased facial expression, seek medical attention immediately.
If you are a doctor and suspect your little patient has botulism, call 510-231-7600 immediately for a consultation. Consultation is available 24 hours a day, seven days a week.
On November 7, 2025, the FDA notified ByHeart of approximately 83 cases of infant botulism reported nationwide since August 2025, according to ByHeart. Of these, the FDA also noted that 13 infants had received ByHeart formula at some point. The FDA has not identified a direct link between infant formula and these cases, and there is no historical precedent for infant formula causing infant botulism. Botulism is extremely rare in dairy products or infant formula and occurs naturally in environmental sources such as soil, some vegetables and dust.
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