Deadly Bacteria in Baby Formula Triggers Nationwide Recall

In a concerning development, a nationwide recall has been issued for two lots of ByHeart Whole Nutrition Infant Formula after the bacteria that causes botulism was detected in the product. The recall comes after a spike in infant botulism cases in babies who had consumed the powdered formula.

The U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) announced the recall on Nov. 8, 2025. The California Department of Public Health had noticed an increase in infant botulism cases linked to the ByHeart formula and alerted the CDC. Preliminary testing of an open can fed to a sick baby also indicated the presence of the bacteria that produces the deadly botulinum toxin.

So far, 13 infants have been hospitalized due to the contaminated formula, though thankfully no deaths have been reported as of Nov. 10, 2025. The recalled lots, manufactured on April 23 and May 6, 2025, were primarily distributed in July and August of that year. ByHeart has agreed to the voluntary recall but denies the validity of the test results.

While the recalled formula makes up less than 1% of the total infant formula sold in the United States, the incident serves as a stark reminder of the importance of food safety. Parents are advised to immediately dispose of any cans from the affected lots and contact ByHeart for a replacement.