A recall has been initiated for ByHeart Whole Nutrition Infant Formula after federal officials linked it to an outbreak of infant botulism affecting ten states. The U.S. Food and Drug Administration (FDA) has reported 13 hospitalizations since August related to this outbreak, though there have been no reported deaths.
The recall specifically involves two lots of the powdered formula, both of which have a “use by” date of December 1. The affected lot numbers are 206VABP/251261P2 and 206VABP/251131P2. The FDA has advised parents and caregivers to check the bottom of the packaging for identifying information, and to safely dispose of the product. They are also collaborating with retailers to ensure that all potentially contaminated products are removed from shelves.
Infant botulism is a serious condition caused by a toxin produced by bacteria, leading to symptoms such as constipation, poor feeding, and difficulty swallowing, which can escalate to paralysis and potentially death, as noted by the Centers for Disease Control and Prevention (CDC). In light of the situation, the FDA has urged parents who have fed their children ByHeart formula to monitor them closely, as symptoms of botulism may take weeks to manifest.
Cases of infant botulism linked to ByHeart formula have been reported in states including Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, and Washington. ByHeart, headquartered in New York City, acknowledged that the FDA informed them of approximately 83 infant botulism cases reported nationwide since August, of which 13 involved babies who consumed their formula. However, the company mentioned that both FDA and its own tests have not detected botulism in their products.
In a proactive measure, ByHeart stated it aims to eliminate any potential risk and maintain safety standards for infants, emphasizing that the FDA has not established a direct link between their formula and the reported cases. The FDA is actively investigating the source of contamination and whether additional products are affected.
Additionally, the California Department of Public Health has reported an uptick in infant botulism among infants who consumed ByHeart formula since August. Notably, ByHeart specializes in creating organic baby food using grass-fed whole milk, claiming that their formula is formulated to be closer in composition to breast milk. Their products are available at nearly 12,000 retail locations across the U.S., and they account for less than 1% of baby formula sales nationwide.
Treatments such as BabyBIG, an FDA-approved medication consisting of antibodies for fighting botulinum neurotoxins, are available for managing infant botulism according to health officials. The swift actions taken by both ByHeart and the FDA demonstrate a commitment to ensuring the health and safety of infants who may be affected.