FDA Announces Nationwide Recall of Baby Formula Linked to Infant Botulism Outbreak

ByHeart baby formula has been recalled nationwide after being linked to an infant botulism outbreak in 12 states, according to the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC).

Laboratory testing suggests that the ByHeart formula may contain Clostridium botulinum, the bacterium that causes botulism—a rare but potentially deadly illness.

As of Nov. 10, there have been 15 cases of botulism in infants who were exposed to the ByHeart products. All 15 infants were hospitalized, and no deaths have been reported to date.

ByHeart initially recalled a limited number of products on Nov. 8, but the company expanded the recall on Nov. 11.

The recall now affects all ByHeart Whole Nutrition Infant Formula products—including all unexpired lots of formula cans and single-serve “anywhere” sticks. 

FDA/Health.com

The recalled formula was sold online and at major retailers nationwide.

The infants in the outbreak were sickened from Aug. 1 to Nov. 10, 2025, in the following states:

• Arizona
• California
• Illinois
• Kentucky
• Minnesota
• North Carolina
• New Jersey
• Oregon
• Pennsylvania
• Rhode Island
• Texas
• Washington

If you have any ByHeart formula products, do not give them to your child. Instead:

• Take a photo or record the information on the bottom of the package.
• Keep the container in a safe spot and label that product as DO NOT USE.
• If your child develops symptoms, your state health department may want to collect your formula container for testing.
• If your child does not develop symptoms after 30 days, throw the product away.

If your child has already consumed ByHeart formula products, monitor for symptoms of infant botulism, such as:

• Poor feeding
• Loss of head control
• Difficulty swallowing
• Decreased facial expression

“When any of the symptoms of infant botulism occur, caregivers should take the baby to their pediatrician or the emergency room immediately,” Sandra Eskin, CEO of Stop Foodborne Illness, a food safety advocacy group, and former Deputy Under Secretary for Food Safety at the USDA, told Health.

“Botulism is a rare but exceedingly dangerous disease,” Eskin added. “It’s especially heartbreaking when it affects newborns and infants—our most vulnerable population.”