Infant formula is a safe, widely used source of nutrition for millions of babies in the United States. Formula supports healthy growth and development. However, like other powdered foods, powdered infant formula can pose health risks if contaminated—most notably by Cronobacter or Clostridium botulinum.
• Liquid formula is sterile, meaning that when it is produced, it is heat-treated and sealed to kill bacteria and prevent further contamination.
• By contrast, powdered formula is not sterile and therefore can become exposed to bacteria during production.
• Because of this greater risk of contamination, powdered formula for babies under 2 months of age must be mixed with boiling water (and then cooled before feeding).
As of February 2026, 51 babies have contracted infant botulism in recent months and many of them have consumed ByHeart formula. After initially recalling selected lots of the product ByHeart, in mid-November, initiated a recall of all its formula. The Food and Drug Administration (FDA) is still investigating the outbreak and whether the contamination originated in the organic whole milk powder used in the product.
Infant botulism is an extremely rare but serious paralytic illness caused by a toxin that is produced by the bacterium Clostridium botulinum. It attacks the body’s nerves and causes difficulty breathing, muscle weakness, paralysis, and even death. It is caused when infants ingest spores of the bacteria, which can grow in the immature digestive system and produce toxins. This may manifest as constipation, poor feeding, loss of head control, and difficulty swallowing, which can progress to difficulty breathing or respiratory arrest if left untreated.
Beginning in September 2021 and well into 2022, the Centers for Disease Control and Prevention (CDC) received reports of three Cronobacter cases in infants that were later included in an ongoing FDA investigation. Cronobacter infections may have contributed to the deaths of two infants in Ohio during this period. The ill babies had consumed a range of formula brands produced by Abbott Laboratories.
Cronobacter sakazakii, a rare but deadly bacterium, can live in dry foods like powdered infant formula. Contamination can cause serious illness including meningitis (brain/spine inflammation) and necrotizing enterocolitis (severe bowel infection), particularly in infants under 2 months. In infants under 1 year old, Cronobacter usually starts with a fever and poor feeding, excessive crying, or very low energy. Some babies may also have seizures.
While Salmonella contamination is rare, infants—especially newborns, premature babies, or those with weakened immunity—are at higher risk of serious illness if exposed. For this reason, health authorities often consider liquid, ready-to-feed formula safer in early infancy, and they emphasize careful hygiene and proper preparation when using powdered formula to reduce the risk of infection.
A Salmonella infection can be life threatening for infants. Symptoms include: dehydration; vomiting that prevents keeping liquids down; prolonged diarrhea (for more than 24 hours); severe abdominal or rectal pain; a fever higher than 101ºF (38.33ºC); and abnormal stools (either with blood or pus or black and tarry).
