ByHeart Recalls Infant Formula Amid Botulism Outbreak Across 15 States

ByHeart has initiated a nationwide recall of all its infant formula products after 31 infants across 15 states were diagnosed with suspected or confirmed botulism. The affected states include Arizona, California, Idaho, Illinois, Kentucky, Maine, Michigan, Minnesota, North Carolina, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, and Washington. All impacted infants, aged between 16 and 200 days, have been hospitalized; no fatalities have been reported.

The Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) are investigating the outbreak. Preliminary tests by the California Department of Public Health detected Clostridium botulinum in an opened can of ByHeart formula. Further testing is underway to determine the contamination source.

ByHeart's products constitute approximately 1% of the U.S. infant formula market. The company is collaborating with health authorities, providing full access to its facilities, and conducting independent third-party testing on all batches.

Parents and caregivers are urged to discontinue use of ByHeart formula immediately. Symptoms of infant botulism include constipation, poor feeding, loss of head control, and difficulty swallowing, which can progress to respiratory issues. If symptoms appear, seek medical attention promptly.

Retailers are advised to remove all ByHeart products from shelves to prevent further distribution. The FDA continues to monitor the situation and will provide updates as more information becomes available.