ByHeart Whole Nutrition Infant Formula.     

By Joe Lombardi From Daily Voice

Federal health officials are warning parents about a nationwide baby formula recall following reports of infant botulism in several states. The rare illness can be fatal without immediate medical care.

The FDA announced Saturday, Nov. 8, that 13 infants from 10 states have been hospitalized with suspected botulism after consuming ByHeart Whole Nutrition Infant Formula, prompting a voluntary recall. No deaths have been reported.

Federal health officials are warning parents to stop using two lots of ByHeart Whole Nutrition Infant Formula after it was linked to cases of infant botulism in several states. 

The rare illness can be fatal without immediate medical care.

The FDA announced Friday, Nov. 8, that 13 infants from 10 states have been hospitalized with suspected botulism after consuming ByHeart powdered formula. No deaths have been reported. 

The agency said all affected infants were confirmed or suspected to have consumed the same brand, prompting a voluntary recall.

The recall involves ByHeart Whole Nutrition Infant Formula, lots 206VABP/251261P2 and 206VABP/251131P2, each marked “Use by 01 Dec 2026.” 

The lot code and use-by date are printed on the bottom of each can. Parents and caregivers are urged to record the code and throw the product away immediately.

Click here to view product labels on the FDA website.

Symptoms of infant botulism can include constipation, poor feeding, loss of head control, difficulty swallowing, or decreased facial movement. These symptoms can progress to trouble breathing or respiratory arrest.

Health officials say symptoms may take weeks to appear. Anyone who observes these signs should seek immediate medical attention.

The FDA said ByHeart products account for less than one percent of all baby formula sold in the US and that the recall will not lead to shortages. The formula was distributed nationwide and sold both online and in stores.

The investigation is being led by the FDA and CDC, along with California’s Department of Public Health and its Infant Botulism Treatment and Prevention Program. 

Testing of leftover formula samples from several states is underway. Officials said they are still working to determine where the contamination occurred and whether additional products could be affected.

For physicians: If an infant patient is suspected of having botulism, clinicians should call 510-231-7600 for case consultation, available 24 hours a day.

Case totals: 13 illnesses, 13 hospitalizations, no deaths. States affected include Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, and Washington.

Check back to Daily Voice for updates.