Copyright The Boston Globe
ByHeart recalled two batches - 206VABP/251261P2 and 206VABP/251131P2, both with a “Use by” date of Dec. 1 - of its Whole Nutrition Infant Formula, the FDA said in a statement Saturday. The code and date can be found on the bottom of the container, the agency said. The company said the recall was voluntary and “out of an abundance of caution.” Infant botulism is contracted when swallowed spores from bacteria called Clostridium botulinum make toxins in a baby’s large intestine, according to the CDC. Symptoms of infant botulism include poor feeding, loss of head control, difficulties with swallowing and breathing, decreased facial expression and a weak and altered cry. It can be fatal in rare cases. The symptoms can take as long as several weeks to develop, the CDC said. The 13 cases linked to ByHeart formula were reported in Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas and Washington. The affected children ranged from around 2 weeks to 5 months old, the CDC said. ByHeart formula, sold online and in major stores nationwide, markets itself as “the next-gen formula” that “gets closest to breast milk.” In a statement, the company said no toxins related to infant botulism have been found in its products. The Department of Health and Human Services, which houses the FDA and CDC, did not immediately respond to a request early Sunday for comment. The FDA said that officials collected leftover infant formula for testing and that results are expected in the coming weeks. The FDA urged parents and caregivers to seek immediate care if a child has consumed the recalled product and is experiencing any of the symptoms. ByHeart urged consumers to “immediately discontinue” using the product and dispose of it, adding that it would offer replacements at no cost. ByHeart makes up less than 1 percent of baby formula sold in the United States, the FDA said, adding that the outbreak does not create shortage concerns. The agency is also working to “determine the point of contamination” and whether other infant products have been affected, it said.
