Public health officials investigating outbreak of infant botulism traced to ByHeart formula

Federal and state officials are investigating an outbreak of infant botulism traced to ByHeart brand formula powder.

As of Nov. 8, there were 13 confirmed patients across 10 states: Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas and Washington. No death have been reported as yet.

The Food and Drug Administration has been in contact with the company and has recommended a recall. The company agreed and has recalled two lots of ByHeart Whole Nutrition Infant formula —Lot: 206VABP/251261P2 and Lot: 206VABP/251131P2 — that were reported to have been consumed by the sick infants. 

“Infant botulism is a very rare disease that occurs when babies inhale or swallow spores of the toxin-producing bacteria that cause infant botulism, which leads to progressive muscle weakness including trouble breathing if not treated in time.” said Dr. Erica Pan, CDPH Director and State Public Health Officer. “We have tested a sample of the specific powdered infant formula linked with these cases and preliminary tests are positive. We are urging parents to stop using ByHeart formula immediately.”

“Botulism, especially in children, can be severe and even deadly,” said Bill Marler, managing partner at Marler Clark, Inc., PS, The Food Safety Law Firm. “This is the first time that I have seen botulism in a dried powdered product. The fact that it is designed for infant consumption should be concerning to all,” added Marler.

The FDA is being assisted in the investigation by state departments of health and the Infant Botulism Treatment and Prevention Program (IBTPP). 

The California Department of Health 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 patients 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.

There is concern that consumers may have unused portions of the recalled formula in their homes because of its long shelf life, which extends into 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 by 01 Dec 2026”)
• Lot: 206VABP/251131P2 (“Use by 01 Dec 2026”)

ByHeart Whole Nutrition Infant Formula makes up an estimated less than 1 percent of all infant formula sold in the United States and this outbreak does not create shortage concerns of infant formula for parents and caregivers. The formula is available in stores nationwide and online.

Most infants with infant botulism will initially develop constipation, poor feeding, loss of head control, and difficulty swallowing, which can progress to difficulty breathing and respiratory arrest. Symptoms of infant botulism, which is diagnosed clinically, can take as long as several weeks to develop following formula ingestion.

Consumers should not use the recalled ByHeart Whole Nutrition Infant Formula and should throw this product away immediately. If your child is experiencing symptoms after consuming ByHeart Whole Nutrition Infant Formula and you still have the formula in your home, please record the information on the bottom of the package before throwing it away.

Botulism can be fatal, and you should take action right away. If your child has consumed ByHeart Whole Nutrition Infant Formula and is experiencing signs and symptoms of botulism such as poor feeding, loss of head control, difficulty swallowing, or decreased facial expression, seek immediate health care. 

If you are a physician and suspect your infant patient has botulism, immediately call 510-231-7600 for case consultation. Consultation is available 24 hours a day seven days a week.

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.

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Source: https://www.foodsafetynews.com/2025/11/public-health-officials-investigating-outbreak-of-infant-botulism-traced-to-byheart-formula/