Massive recall on baby formula contaminated with deadly bacteria
In this DML Report…
The FDA notified ByHeart, a Pennsylvania-based baby formula manufacturer, on November 7, about potential contamination in its Whole Nutrition Infant Formula linked to an outbreak of infant botulism. Since August 2025, 83 cases of infant botulism have been reported nationwide, with 13 hospitalized infants having consumed ByHeart formula prior to illness. These cases span 10 states: Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, and Washington. The outbreak involves spores of Clostridium botulinum, which can grow in an infant's intestines and produce botulinum toxin, leading to the voluntary recall of two specific batches.
Preliminary testing by the California Department of Public Health on an opened can of ByHeart formula fed to an affected infant indicated the presence of the bacteria, though no direct causal link has been confirmed. The recalled batches are 251261P2 and 251131P2, both with a use-by date of December 1, 2026, and UPC code 5004496800. ByHeart stated that none of its products have tested positive for contaminants in internal or third-party evaluations and emphasized adherence to stringent safety protocols. The recall was initiated as a precautionary measure following the FDA's alert.
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Infant botulism symptoms include constipation, poor feeding, drooping eyelids, weak cry, low muscle tone, and respiratory issues, requiring prompt medical attention. Treatment typically involves administration of botulism immune globulin intravenous (BIG-IV) antitoxin, along with supportive care such as hospitalization and mechanical ventilation if necessary. Consumers with the affected formula are advised to stop use immediately, dispose of the product, and contact ByHeart for a free replacement. The company is cooperating with the FDA to investigate the matter further.