All ByHeart formula may be contaminated

 ByHeart said Monday that it “cannot rule out” that all of its infant formula was contaminated, less than two weeks after an infant botulism outbreak caused it to recall its products. 

The company, in a note to parents on its website, said after the Food and Drug Administration (FDA) informed it of the outbreak, it tested 36 product samples. Five of those samples, it said, tested positive for clostridium botulinum Type A, known as infant botulism. 

“Based on these results, we cannot rule out the risk that all ByHeart formula across all product lots may have been contaminated,” the company said. “We continue to be focused on finding the root cause, through a rigorous audit of every step of our product development chain, from suppliers and raw ingredients, through to packaging and transportation.”

The Department of Health and Human Services, which oversees the FDA, said Tuesday its investigation into the outbreak is ongoing and it intends to update its advisory with the latest information Wednesday.

ByHeart initially recalled two batches of its Whole Nutrition Infant Formula on Nov. 8, one day after the FDA notified it of a link between the product and a multi-state outbreak of infant botulism. 

Three days later, the company recalled all of its products nationwide after the FDA informed it of two more infant botulism cases in babies who consumed formula not included in the first recall.

As of last week, though, at least three states — Oregon, Minnesota and Arizona — had the formula on store shelves, according to The Associated Press.

As of Nov. 19, 31 infants in 15 states with suspected or confirmed infant botulism were exposed to ByHeart formula. All infants were hospitalized, with no deaths reported.  

ByHeart added Monday that it will provide a full refund for all products purchased on its website on or after Aug. 1. Customers can expect to receive refunds within five to seven days after speaking with a ByHeart representative. 

Infant botulism, an intestinal toxemia, results when babies swallow spores of the clostridium botulinum bacteria or related species, according to the Centers for Disease Control and Prevention (CDC). The spores then grow in an infant’s large intestine and produce neurotoxin.

The initial symptoms may present as constipation, poor feeding, a drooping eyelid, sluggish pupils, flattened facial expression, diminished suck and gage reflexes, weak and altered cry and respiratory difficulty, the CDC adds. The disease can result in bulbar palsies, hypotonia and a symmetric, descending, flaccid paralysis.

https://thehill.com/policy/healthcare/5622329-byheart-infant-formula-botulism/