Possible source of botulism outbreak from contaminated infant formula discovered

Parents, double-check that baby formula in the pantry.

After an outbreak of botulism that hospitalized dozens of babies last winter, the FDA has discovered a potential source.

After 51 babies fell ill across 19 states with botulism, New York-based ByHeart Inc. voluntarily recalled their Whole Nutrition Infant Formula.

Now, follow-up testing by the FDA has discovered a potential source of the deadly illness.

After comparing samples from a sick baby to an unopened can of formula, bacteria were discovered to come from organic whole milk powder.

ByHeart used this ingredient to make their popular milk-based formula with iron, including the recalled lots 206VABP/251261P2 and 206VABP/251131P2.

However, the test results are not conclusive, and the FDA is continuing its investigation into the source of the contamination. Meanwhile, the supplier of the powdered milk has not been identified.

According to the CDC, no new cases have been reported since mid-December, and there have been no deaths.

Infant botulism cases were initially reported across multiple states starting back in 2023, including California, New Jersey, Pennsylvania, Texas and more.

Although rare, this illness is a life-threatening condition caused by the bacteria Clostridium botulinum.

This can cause constipation, as well as difficulty feeding, a weak or altered cry and lack of head control.

The contaminated baby formula accounted for an estimated 1% of national formula sales, according to the CDC.

Those who bought the recalled formula are advised to use hot, soapy water to clean any items or surfaces that touched the contaminated product. 

The FDA also urged caregivers to seek immediate help if an infant who consumed the formula begins experiencing poor feeding, loss of head control, difficulty swallowing or decreased facial expression. 

Following the investigation and continued testing, ByHeart is committed to improve the manufacturing of its key product.

“We are focused on the root cause and our responsibility to act on what we’ve learned to help create a safer future for ByHeart and infant formula,” Dr. Devon Kuehn, ByHeart’s chief scientific and medical officer, told Fox News.

This news comes after the FDA and Health and Human Services announced “Operation Stork Speed“, an initiative to increase testing of domestic infant formula supply for contaminants, including heavy metals, last March.