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

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

Laboratory testing suggests that ByHeart formula may contain Clostridium botulinum, the bacteria responsible for botulism, a rare but potentially fatal disease.

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

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

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

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

Infants involved in the outbreak became ill from August 1 to November 10, 2025 in the following states:

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

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

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

If your child has previously consumed ByHeart formula, watch for symptoms of infant botulism, such as:

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

“When any of the symptoms of infant botulism appear, caregivers should take the baby to their pediatrician or emergency room immediately,” said Sandra Eskin, CEO of Stop Foodborne Illness, a food safety advocacy group and former deputy assistant secretary for food safety at the USDA. Health.