The Byheart Infant Formula botulism outbreak has sickened 31 babies as of November 19, 2025, according to the CDC, an increase of eight more patients since the last update was issued on November 14, 2025. All eight infants have been hospitalized, and two more states are added to the case count. The new states are Idaho and Maine.
The case count by state is: Arizona (3), California (4), Idaho (1), Illinois (2), Kentucky (1), Maine (1), Michigan (1) Minnesota (2), North Carolina (2), New Jersey (1), Oregon (3), Pennsylvania (1), Rhode Island (1), Texas (6), and Washington (2). For 23 infants whose age was made available to public health officials, they range in age from 16 to 200 days. Illness onset dates range from August 9 to November 13, 2025 for 27 of these infants. All of the infants were hospitalized and treated with BabyBIG®, the FDA-approved treatment for this infection developed by the California Department of Health.
Epidemiologic and laboratory results show that ByHeart Whole Nutrition Infant formula may be contaminated with Clostridium botulinum bacteria and has made babies sick. Testing conducted by the California Department of Health found presumptive positive results for Clostridium botulinum in some samples of the formula.
ByHeart has issued a statement about this outbreak, which reads, in part, “Our core mission has always been protecting babies. After the FDA informed us of the infant botulism outbreak on November 7, we immediately partnered with IEH Laboratories and Consulting Group, a global leader in Food Safety eating, to test cans of ByHeart Formula, and conducted a nationwide recall. We have just learned that those tests identified Clostridium botulinum in some samples of ByHeart Formula. We immediately notified the FDA of these findings, and we are working to investigate the facts, conduct ongoing testing to identify the source, and ensure this does not happen to families again.
“We continue to urge parents and caregivers to stop using ByHeart formula immediately, monitor your child for symptoms of infant botulism, and seek medical care immediately if they develop symptoms.”
The California Department of Health has set up a hotline to answer questions and concerns that parents and caregivers have. The hotline, 1-833-398-2022, is open seven days a week from 7:00 am to 11:00 pm Pacific Time.
All ByHeart formula has been recalled. If you bought any of this formula, do not feed it to your child. You can throw the formula away or return it to the place of purchase for a full refund.
If you fed your child this formula, watch them for symptoms of baby botulism, which can take several weeks to appear. If they do appear ill, see your pediatrician immediately or go to the emergency room. They may be part of this ByHeart Infant Formula botulism outbreak.
If your child has been sickened with a botulism food poisoning infection, please contact our experienced attorneys for help with a possible lawsuit at 1-888-377-8900 or text us at 612-261-0856. Our firm represents clients in lawsuits against grocery stores, restaurants, and food processors.
