The FDA weighs in on the ByHeart Whole Nutrition Formula botulism outbreak, stating that, “Epidemiologic and laboratory data show that ByHeart Whole Nutrition infant formula might be contaminated with Clostridium botulinum, which is causing infant illness in multiple regions of the country.”
The case count by state is: Arizona (1), California (2), Illinois (2), Kentucky (1), Minnesota (1), North Carolina (1), New Jersey (1), Oregon (1), Pennsylvania (1), Rhode Island (1), Texas (2), and Washington (1). For 14 infants whose age is available, they range in age from 16 to 157 days. Illness onset dates range from August 9 to November 10, 2025. All of the infants were hospitalized and treated with BabyBIG®, the FDA-approved treatment for this infection developed by the California Department of Health.
One interesting thing that the FDA report mentioned is that detection of Clostridium botulinum bacteria in infant formula is difficult, “and a negative test result does not rule out the presence of bacteria in the product.” The California Department of Health lab reports suggest the presence of Clostridium botulinum bacteria in an open can of the ByHeart formula that was fed to a sick infant.
The epidemiological evidence is that all 15 infants were fed ByHeart Whole Nutrition Infant formula before they got sick. That is a disproportionate number, given that ByHeart only represents 1% of all infant formula brands sold in this country.
All ByHeart formula has been recalled. Do not feed it to your infant. You can throw it away in a secure garbage can or you can take it back to the store where you bought it for a refund.
If you did feed your infant this brand of formula, monitor their health for the symptoms of infant botulism for the next few weeks. If your baby does get sick, see your pediatrician as soon as possible, telling him or her about your concerns and that your baby was fed ByHeart powdered formula.
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.
