Topline
Organic baby formula producer ByHeart recalled all of its products Tuesday after health officials discovered two more cases of infant botulism in children fed the company’s formula, as the Food and Drug Administration investigates an ongoing outbreak.
Key Facts
In a statement on Tuesday, ByHeart apologized to parents for causing “immense anxiety and fear,” and warned “all ByHeart product must be discarded,”—including all of the company’s canned formula, along with its “anywhere pack” single-serving formula packets.
ByHeart previously recalled two batches of formula over the weekend after the FDA and Centers for Disease Control informed the company that 13 cases of infant botulism were found in children who consumed the company’s formula.
Botulism is caused by a toxin made by the Clostridium botulinum bacteria, according to the CDC, but neither the company nor health authorities have found the bacteria’s spores or toxins in unopened ByHeart products.
ByHeart also said it would provide the FDA and CDC “complete and unrestricted access to all of our facilities and products.”
Surprising Fact
The CDC has recorded 84 cases of infant botulism since August 1 across 12 states. Out of those cases, 36 of the children infected consumed powdered baby formula. The 15 cases linked to ByHeart products represent a significant 40% of all cases, the CDC warned.