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An outbreak of infant botulism linked to ByHeart Whole Nutrition Infant Formula has expanded, with at least 15 babies across 12 states now affected. The U.S. Food and Drug Administration and the Centers for Disease Control and Prevention are investigating the outbreak, which began with 13 cases in ten states. The FDA has confirmed that all affected infants consumed ByHeart formula and are being treated with BabyBIG, a specialized IV medicine for botulism.
ByHeart, a New York City-based company, initially issued a voluntary recall of two formula lots but has now expanded the recall to include all its products nationwide. Despite the recall, no unopened ByHeart product has tested positive for Clostridium botulinum spores or toxin. The company stated, "The safety and well-being of every infant who uses our formula is, and always will be, our highest priority," according to ABC News.
Symptoms of infant botulism include poor feeding, constipation, and difficulty breathing. The illness can lead to severe complications like respiratory arrest. The FDA advises parents and caregivers to stop using ByHeart formula immediately and seek medical care if their infant shows symptoms.
The outbreak has raised concerns, as ByHeart formula accounts for less than 1% of U.S. infant formula sales, yet is disproportionately represented among the sick infants. The investigation is ongoing, with no other formula brands currently identified as posing a risk. For more information, parents can contact ByHeart at hello@byheart.com or (833) 429-4327.
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