Health Advisory

NYS DEPARTMENT OF HEALTH ADVISORY NOVEMBER 2025:
 RECALL OF INFANT FORMULA RELATED TO BOTULISM TYPE A OUTBREAK

Since August, 15 cases of infant botulism in infants who consumed ByHeart brand infant formula have been reported to the Centers for Disease Control and Prevention (CDC) from 12 states. States reporting cases include Arizona, California, Illinois, Kentucky, Minnesota, New Jersey, North Carolina, Oregon, Pennsylvania, Rhode Island, Texas, and Washington. Cases range in age from 16 days old to several months old. No cases have been identified in NYS to date. So far, no deaths have been reported. 

Cases have been reported from August through the present. Nine of the cases have been confirmed by testing that showed botulinum toxin type A. 

FDA issued communications about a recall of all lots of infant formula from ByHeart Whole Nutrition Infant Formula, in all sizes of cannisters and pouches. 

Infants should not be fed the recalled formula. If parents and caregivers still have any ByHeart Infant Formula product, they should:

• take a photo or record the information on the bottom of the package

• keep the container in a safe spot and be sure to label that product as DO NOT USE.

• If the child develops symptoms, the product might be needed for testing. If the child does not develop symptoms after 30 days, they should throw the containers out.

Infant botulism is the most common type of botulism in the United States. Symptoms usually present in children less than twelve months of age and include constipation, loss of appetite, weakness, poor suck, ocular palsies, an altered cry, and a striking loss of head control. Progression of symptoms is
more severe in infants under two months of age. Infants become infected by ingestion of C. botulinum spores that germinate in the colon, rather than ingestion of preformed toxin. It can take up to 30 days from the date of exposure to develop signs and symptoms.