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 that has now hospitalized a total of 15 infants who consumed the company’s formula.
ByHeart previously recalled two batches of formula after the disease was found in babies who consumed the product.
Associated Press
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.
All 15 infants who have contracted the disease have been hospitalized, according to the CDC.
The hospitalized infants range in age from seven to 157 days, according to the CDC, and no deaths have been reported.
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 those cases, the CDC warned.
Read More
Source: https://www.forbes.com/sites/zacharyfolk/2025/11/11/organic-baby-formula-producer-byheart-recalls-all-products-in-us-as-infant-botulism-outbreak-spreads/
