Infant Formula May Cause Serious Illness In Babies, Says FDA

PASCO COUNTY, FL — The U.S. Food and Drug Administration, along with the U.S. Centers for Disease Control and Prevention, have issued an FDA advisory warning consumers not to use certain powdered infant formula produced in Abbott Nutrition's facility in Sturgis, Michigan, and sold across the country as well as other countries.

Abbott has initiated a voluntary recall of potentially affected formula including 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.
• The expiration date is 4-1-2022 (APR 2022) or later.

The FDA is investigating complaints of Cronobacter sakazakii and Salmonella infections after four infants from three states became ill and were hospitalized. One of the babies infected with Cronobacter sakazakii has died. The cases are in Minnesota, Ohio and Texas.

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. Cronobacter infection may also cause bowel damage and may spread through the blood to other parts of the body.

Salmonella are a group of bacteria that can cause gastrointestinal illness and fever called 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 be fatal.

Consumers who used the formula and have a baby who is experiencing any symptoms should seek immediate medical care, said the FDA.

The FDA has done an on-site inspection at the facility in Sturgis and have gotten several positive Cronobacter sakazakii.

“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,” said Frank Yiannas, FDA deputy commissioner for food policy and response. “We want to reassure the public that we’re working diligently with our partners to investigate complaints related to these products, which we recognize include infant formula produced at this facility, while we work to resolve this safety concern as quickly as possible.”

Among the mothers who have received the suspect formula are women enrolled in the Florida Women, Infants and Children (WIC) Program in Pasco County.

Once the recall was announced, Pasco County WIC staff began contacting the WIC participants who were given the formula and told not to use it.

However, the agency has no replacement formula in its inventory to give the disadvantaged mothers who qualify for WIC.

"The staff is working very hard to provide replacement formula as quickly as possible," Pasco WIC Director Jennifer Parker said.

Parker said new formula has been ordered, but may take several days to arrive.

For additional information, visit the FDA website.