Several powdered infant formula products have been recalled by Abbott Inc., following reports of four infants developing bacterial infections after consuming the products, the U.S. Food and Drug Administration said Thursday.
"As this is a product used as the sole source of nutrition for many of our nation's newborns and infants, the FDA is deeply concerned about these reports of bacterial infections," Frank Yiannas, FDA Deputy Commissioner for Food Policy and Response, said in an agency news release. "We want to reassure the public that we're working diligently with our partners to investigate complaints related to these products... while we work to resolve this safety concern as quickly as possible."
Consumers should not use Similac, Alimentum, or EleCare powdered infant formulas if: the first two digits of the code are 22 through 37; the code on the container contains K8, SH or Z2; and the expiration date is 4-1-2022 (APR 2022) or later, the FDA warned.
The agency is investigating three Cronobacter sakazakii infections and one Salmonella Newport infection among four infants in three states - Minnesota, Ohio and Texas. All of the infants were hospitalized and Cronobacter may have contributed to a death in one case.
The recalled powdered infant formula products were produced at Abbott Nutrition's facility in Sturgis, Mich., and sold across the United States and likely exported to other countries, according to the FDA.
The agency said it has launched an inspection at the facility. To date, several environmental samples taken at the plant have tested positive for Cronobacter.
A review of Abbott's internal records also reveal environmental contamination with Cronobacter and the destruction of product due to the presence of Cronobacter, the FDA said.
The FDA is conducting the investigation with the U.S. Centers for Disease Control and Prevention and state and local agencies.
Cronobacter bacteria can cause severe, life-threatening infections (sepsis) or meningitis (an inflammation of the membranes that protect the brain and spine).
Symptoms of sepsis and meningitis may include poor feeding, irritability, temperature changes, jaundice (yellow skin and whites of the eyes), grunting breaths and abnormal movements, the FDA said.
Cronobacter infection may also cause bowel damage and may spread through the blood to other parts of the body.
If you have an infant who has consumed these products and you are concerned about their health, contact your child's health care provider. If your child is experiencing any of these symptoms, notify your child's health care provider and seek medical care for your child immediately, the FDA advised.
Salmonella can cause salmonellosis. Most people with salmonellosis develop diarrhea, fever and abdominal cramps. More severe cases of salmonellosis may include a high fever, aches, headaches, lethargy, a rash, blood in the urine or stool, and in some cases, may cause death, the agency said.
There's more on Cronobacter at the U.S. Centers for Disease Control and Prevention.
SOURCE: U.S. Food and Drug Administration, news release, Feb. 17, 2022