Federal health officials on Wednesday expanded an outbreak of infant botulism tied to recalled ByHeart baby formula to include all illnesses reported since the company began production in March 2022.
The U.S. Food and Drug Administration stated that investigators “cannot rule out the possibility that contamination might have affected all ByHeart formula products” ever made.
The outbreak now includes at least 51 infants in 19 states. The most recent case was reported on December 1.
No deaths have been attributed to the outbreak, which was first announced on November 8. Health officials had previously reported 39 cases traced to ByHeart formula since August, leading to a substantial recall of their products.
ByHeart, a New York-based infant formula manufacturer founded in 2016, recalled all its products sold in the U.S. on November 11, causing concern for many parents relying on their formula.
News that ByHeart products could have been contaminated for years was distressing to Andi Galindo, mother of a hospitalization case in December 2023.
The FDA sent inspectors to ByHeart's production facilities, but results have not yet been released. Previous independent tests showed that several lots were contaminated with bacteria capable of causing infant botulism.
The sole treatment for this rare disease, known for affecting fewer than 200 infants in the U.S. per year, is BabyBIG, made from the pooled blood plasma of adults immunized against botulism. Treatment must be timely and effective to mitigate the risk to infants.
Families affected by the botulism cases have initiated lawsuits against ByHeart, seeking accountability for the alleged negligence in the safety of their products.
