ATLANTA (AP) — The Centers for Disease Control and Prevention said Thursday that a rare outbreak of infant botulism that sickened dozens of babies who drank recalled ByHeart formula is over, with no new cases reported since mid-December.
Health officials said a total of 48 babies have become ill since 2023. This was actually a decrease from previous case numbers, as three babies were eventually diagnosed with other illnesses unrelated to botulism.
All sick children were taken to the hospital. No deaths have been reported.
It’s unclear exactly how, when or where organic whole-fat infant formula became contaminated with bacteria that can cause serious illness, paralysis and death in children under 1 year old, health officials added.
Most of the cases have occurred since August, when officials with California’s Infant Botulism Treatment and Prevention Program saw an alarming increase in reports of illness in infants eating ByHeart formula.
New York-based ByHeart initially recalled two batches of formula in early November, but days later the company expanded the recall to include all products. Federal health officials later said they could not rule out the possibility of contamination in products produced by the company since it was first launched in March 2022. Stores nationwide pulled the product, which was promoted as having “benefits second only to breast milk”.
FDA investigators have not yet determined the root cause.
The agency said in a statement that 17 different strains of the disease-causing bacteria have been identified in patient samples, finished canned milk powder and ingredients. The agency said the samples “add to the existing evidence needed to investigate the root causes of this outbreak” but were not clear-cut.
Previously, FDA officials said that whole milk powder used in the production of ByHeart infant formula may be the source of contamination.
Food safety experts say illnesses caused by Clostridium botulinum in infant formula are rare, and the scale and scope of the ByHeart outbreak are unprecedented.
The disease occurs when a baby ingests botulinum spores, which germinate in the intestines and produce dangerous toxins that attack the nervous system. Mortality rates were once as high as 90%, but are now less than 1% with treatment.
The only treatment for the disease is an intravenous drug called BabyBIG, which is made from a pool of blood plasma from adults who have been vaccinated against Botox. California’s plan is the only source worldwide.
ByHeart accounts for about 1% of the U.S. infant formula market and previously sold about 200,000 cans of the product each month. Parents of babies who became sick during the outbreak said they chose the formula, which sells for about $42 a can, because of its touted health benefits.
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