Federal officials said that an outbreak of infant botulism linked to recalled baby formula products has expanded to more states.
In an update on Nov. 26, the Centers for Disease Control and Prevention said that six new cases were reported in two more states since the last update, roughly a week ago. The total now stands at 37 cases in 17 states.
No deaths have been reported in connection with the outbreak, but all 37 cases resulted in hospitalizations, according to the CDC. The ages of children impacted range from 16 days to 264 days.
“Laboratory confirmation for some cases is ongoing. For 36 cases with illness onset information available, illnesses started on dates ranging from August 9 through November 19, 2025,” the agency said.
ByHeart Inc., which recalled all of its baby formula products last month, said in its most recent update that testing suggests that it “cannot rule out the risk that all ByHeart formula across all product lots may have been contaminated.”
“We tested 36 samples from three lots and, as shared on November 19th, we received positive test results for Clostridium botulinum Type A in five of the 36 samples across all three lots,” the company said in its update last week, referring to the type of bacteria that is causing the outbreak.
The company added that it is attempting to find the root cause of the contamination “through a rigorous audit of every step of our product development chain, from suppliers and raw ingredients, through to packaging and transportation.”
Consumers who bought ByHeart on the company’s website on or after Aug. 1 can receive a full refund, an expansion of its previous policy, the company said on its website.
Fewer than 200 cases of infant botulism are reported in the United States each year. The disease is caused when babies ingest spores that germinate in the gut and produce a toxin. The bacterium that leads to illness is ubiquitous in the environment, including soil and water, so the source is often unknown.
ByHeart recalled all of its formula nationwide on Nov. 11. However, some products have remained on store shelves despite the recall, according to state officials and the Food and Drug Administration.
An official with the CDC said last month that federal investigators were aware of reports of earlier illnesses but that efforts are focused now on understanding the unusual surge of dozens of infections documented since Aug. 1.
“That doesn’t mean that they’re not necessarily part of this,” said Dr. Jennifer Cope, a CDC scientist leading the probe. “It’s just that right now, we’re focusing on this large increase.”
The parents of two children who may have been sickened in the outbreak have since filed lawsuits against ByHeart, alleging negligence on behalf of the company. The company has not yet responded in court, and a previous Epoch Times request for comment went unanswered.
Symptoms of infant botulism include constipation, poor feeding, weak suckling, a loss of head and muscle control, drooping eyelids, lethargy, a lack of facial expression, and a weak cry, according to the Cleveland Clinic. Symptoms can progress to breathing difficulty, a breathing pause, or paralysis.
To report an illness linked to the outbreak, contact an FDA consumer complaint coordinator or submit an online MedWatch form.
The Associated Press contributed to this report.
