ByHeart infant formula tests linked to a Food poisoning outbreak Which led to dozens of children falling ill, showed that all of the company’s products may be contaminated.
The company said Monday on its website that laboratory tests conducted on 36 samples of the formula from three different batches showed that five samples contained the type of bacteria that can lead to the rare and fatal disease.
“Based on these findings, we cannot rule out the risk that all ByHeart formulations across all product families are contaminated,” the company wrote.
At least 31 children in 15 states who took ByHeart formula became ill in the outbreak that began in August, according to federal and state health officials. In addition, other infants Those who drank the ByHeart formula were treated for food poisoning in the preceding months, up until November 2024, although they were not counted in the outbreak, officials said.
Clostridium botulinum type A, the type of bacteria detected, can be unevenly distributed in the powdered formulation. Medical experts said that not all children who eat it will develop the disease, although all children under the age of one are at risk.
ByHeart pulled all of its fixtures nationwide on November 11. However, some products have been deleted It remained on store shelves Despite the recall, according to state and FDA officials.
Parents and caregivers should stop formula feeding children immediately and monitor children for symptoms, which may take up to 30 days to appear.
Infant botulism occurs when babies ingest germs that grow in their intestines and produce a toxin. Symptoms include constipation, difficulty sucking or feeding, drooping eyelids, flat facial expressions, and weakness in the arms, legs, and head. This disease is a medical emergency and requires immediate treatment.
At least 107 children across the country have been treated for food poisoning with an IV medication known as BabyBIG since Aug. 1, health officials said. In a typical year, fewer than 200 infants are treated for the disease.
To report an outbreak-related illness, contact Consumer Complaints Coordinator for the Food and Drug Administration (FDA). Or fill MedWatch online form.
The company said consumers who purchased ByHeart on the company’s website on or after August 1 can get a full refund, an expansion of its previous policy.
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