ByHeart’s Powdered Formula Investigation

Berger Montague attorneys are investigating formula manufacturers, and particularly ByHeart, following a recent outbreak of infant botulism across the United States. At least 15 infants in 12 different states, each under 5 months old, have been hospitalized with botulism since August after consuming ByHeart’s powdered infant formula products. The Federal Drug Administration has instructed caregivers to stop using ByHeart’s powdered formulas in light of the recent outbreak.

The F.D.A., along with the Centers for Disease Control and Prevention and state and local health agencies, is continuing to investigate the outbreak. The C.D.C. advises that parents and caregivers should immediately stop using the recalled formula. Anyone who has fed the formula to an infant should keep the container and monitor the child for signs of botulism, which can take up to 30 days to appear. Botulism can be fatal, and its symptoms include poor feeding, loss of head control, difficulty swallowing, and decreased facial expression.

ByHeart manufactures organic baby formulas, and its products account for approximately 1% of all baby formulas on the market. On Saturday, November 9, ByHeart recalled two batches of its Whole Nutrition Infant Formula in response to findings from health agencies of an increase in botulism rates among infants who had consumed that product. ByHeart expanded the recall on Tuesday, November 11, to include all products it sells nationwide.

If you or anyone you know has a child who has been diagnosed with botulism after consuming one of ByHeart’s powdered formula products, please get in touch with us at 1-800-424-6690 or email us at info@bergermontague.com or use the form on the right-hand side of this page.

Read more about the incident here:

• ByHeart recalls all baby formula sold nationwide as infant botulism outbreak grows, ABC News, November 11, 2025

• Infant Botulism Outbreak Linked to Infant Formula, November 2025, Centers for Disease Control and Prevention, November 11, 2025

• Infant Formula Recall Expands as Botulism Outbreak Grows, New York Times, November 11, 2025

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