The Food and Drug Administration (FDA) has expanded its investigation into an outbreak of infant botulism linked to ByHeart Whole Nutrition Infant Formula. The agency is now recommending that parents and caregivers avoid using any ByHeart infant formula products, including all unexpired cans and single-serve “anywhere” sticks.
This action comes after reports of additional cases of suspected infant botulism among infants who consumed the product, the identification of new lot codes, and a preliminary positive sample collected during testing. According to the FDA, “ByHeart infant formula products makes up less than 1% of all infant formula sold in the United States and this outbreak does not create shortage concerns of infant formula for parents and caregivers.”
ByHeart Whole Nutrition Infant Formula has been available both online and at major retailers nationwide.
Infant botulism can present with symptoms such as constipation, poor feeding, loss of head control, difficulty swallowing, decreased facial expression, and can progress to difficulty breathing or respiratory arrest. Symptoms may take several weeks to appear after ingestion. Parents are advised: “Parents and Caregivers should stop using any ByHeart infant formula products immediately.” If an infant who consumed ByHeart formula shows symptoms consistent with botulism, immediate medical attention is recommended.
The FDA also advises parents who still have ByHeart formula at home to document package information, label it as “DO NOT USE,” and keep it in a safe place in case health authorities need it for testing. If no symptoms develop within 30 days after consumption, containers should be discarded.
Physicians suspecting an infant patient has botulism are instructed: “If you are a Physician and suspect an infant patient has botulism, immediately call 510-231-7600 for case consultation. Consultation is available 24/7.”
The FDA’s investigation remains ongoing.
