(LOOTPRESS) – A growing outbreak of infant botulism has now sent 37 infants to hospitals across 17 states, federal health officials confirmed Wednesday. The Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) announced that the number of suspected or confirmed cases has risen by six since their previous update on Nov. 20.
The illnesses, which began between Aug. 9 and Nov. 19, 2025, have now been reported in Arizona, California, Idaho, Illinois, Kentucky, Massachusetts, Maine, Michigan, Minnesota, North Carolina, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, Washington, and Wisconsin, according to the CDC.
“All 37 infants were hospitalized,” the FDA stated, noting that no deaths have been reported. Among 35 infants with available demographic details, ages ranged from 16 to 264 days, and 15 were female.
Outbreak Traced to ByHeart Infant Formula
Federal investigators have linked all known cases to the consumption of various lots of ByHeart Whole Nutrition powdered infant formula. Laboratory testing is still underway to confirm the presence of the bacteria responsible for botulism.
The FDA, CDC, and the California Department of Public Health’s Infant Botulism Treatment and Prevention Program are jointly leading the investigation, which aims to determine how and where contamination occurred.
ByHeart initiated a voluntary recall on Nov. 8, initially affecting two batches of its Whole Nutrition Infant Formula. By Nov. 11, the company expanded the recall to cover all batches of its formula, including canned products and Anywhere Pack single-serve sticks, distributed nationwide.
On Nov. 19, ByHeart reported that 5 of 36 tested samples—spanning three lots—were positive for Clostridium botulinum Type A, prompting the company to warn that contamination could be present across all product lots.
“We want to reaffirm the critical direction for parents and caregivers to stop using ByHeart formula immediately,” the company said, urging caregivers to monitor infants closely for symptoms.
Symptoms and Risks of Infant Botulism
Botulism, though rare, is a dangerous illness caused by a potent neurotoxin that attacks the nervous system. According to the CDC, symptoms in infants may include:
- Poor feeding
- Constipation
- Drooping eyelids
- Reduced facial expression
- Weak cry
- Difficulty swallowing
- Loss of head control
Immediate medical care is recommended for any infant who consumed ByHeart formula and exhibits potential symptoms.
Infant botulism occurs when Clostridium botulinum spores are ingested and grow inside a baby’s gastrointestinal tract. While foods like honey are well-known sources—which is why health authorities advise against giving honey to children under 1 year old—this outbreak marks a rare instance tied to commercial infant formula.
Refunds and Guidance for Parents
ByHeart is offering full refunds for all products purchased on or after Aug. 1, 2025, expanding on an earlier reimbursement policy. The company said the decision reflects newly available FDA data showing the earliest known case in the outbreak began on Aug. 9.
Parents can reach ByHeart customer service at 866-201-9069 or visit the company’s website for refund instructions.
The FDA is urging consumers to discard all recalled ByHeart products immediately and to seek emergency medical care if an infant shows any signs of botulism.
The investigation remains active as federal and state agencies work to pinpoint the source of contamination and prevent further illnesses.
