ByHeart Recalls All Infant Formula Following Botulism Outbreak

NEW YORK — November 21, 2025 — ByHeart announced a nationwide recall of all its infant formula products on Tuesday after health officials identified a botulism outbreak connected to the company’s powdered baby formula. The recall affects all batches of ByHeart’s infant formula distributed across the United States.

Authorities said the recall was initiated after several cases of infant botulism were reported in different states, with investigations pointing to contamination in the powdered formula. Botulism is a rare but serious illness caused by toxins produced by the bacterium Clostridium botulinum, which can cause muscle paralysis and respiratory failure, particularly dangerous for infants.

ByHeart, a company specializing in infant nutrition, stated that it is cooperating fully with public health agencies to identify the source of contamination and prevent further cases. The company urged parents and caregivers to stop using its products immediately and to consult healthcare providers if their infants show symptoms such as constipation, poor feeding, weakness, or breathing difficulties.

The U.S. Food and Drug Administration (FDA) is working alongside the Centers for Disease Control and Prevention (CDC) and state health departments to trace the outbreak and monitor affected infants. Officials have not yet disclosed the total number of confirmed cases but emphasized the urgency of the recall to protect public health.

The recall includes all powdered infant formula products manufactured by ByHeart, regardless of production date or lot number. The company has advised retailers and distributors to remove all ByHeart infant formula from shelves and distribution centers.

Health experts highlight that powdered infant formula is not sterile and can sometimes harbor harmful bacteria if contaminated during production or handling. The FDA recommends careful preparation and storage of powdered formula to minimize risk, but contamination at the manufacturing level poses a significant public health concern.

Parents and caregivers who have used ByHeart infant formula are encouraged to contact the company’s customer service for information on refunds or replacements. The company has set up a hotline and dedicated website to provide updates and guidance.

This recall follows heightened scrutiny of infant formula safety amid previous incidents involving contamination and supply chain issues affecting infant nutrition products nationwide. The FDA continues to monitor the situation closely and advises consumers to stay informed through official channels.

ByHeart has pledged to conduct a thorough review of its manufacturing processes and implement corrective actions to ensure the safety of its products before resuming distribution. The company has not provided a timeline for when its infant formula might return to the market.

Parents and caregivers should consult pediatricians for alternative feeding options during the recall and report any suspected cases of illness related to infant formula consumption to health authorities promptly.

The ongoing investigation underscores the importance of stringent quality controls in infant nutrition products and the need for vigilance among manufacturers, regulators, and consumers alike.