Abbott Nutrition is expanding its recall of powdered baby food formulas to include some Similac PM 60/40 cans and cases produced at a Michigan facility after an infant who was exposed to the powdered formula died, the U.S. Food and Drug Administration said on Monday.
The company's recall expansion comes a little more than a week after it recalled certain Alimentum, Similac and EleCare baby formulas produced in its facility in Sturgis, Michigan, because of complaints about bacterial infections in infants who consumed the products.
The infections stemmed from the bacterium Cronobacter sakazakii and the strain Salmonella newport, according to the FDA. Cronobacter bacteria can cause sepsis, a severe, life-threatening infection, or meningitis, which is an inflammation of the membranes that protect the brain and spine.
Though Cronobacter infections are rare, newborns are at especially high risk.
Salmonella are bacteria that can cause gastrointestinal illness and fever called salmonellosis.
The FDA is advising parents and caregivers to not feed the recalled baby formulas to children in their care.
What brands and products are affected by the recall?
Similac PM 60/40, Similac, Alimentum and EleCare powdered baby formula products produced in Abbott Nutrition's facility in Sturgis, Michigan, are the products to look out for.
The recalls do not include liquid baby formula products.
Where are the products distributed and sold?
The products were distributed across the United States, and some were exported to other countries, according to the FDA. The agency is working with the company to safely resume production at the Michigan facility.
What serial numbers and product codes should consumers look for?
The FDA is telling consumers to examine each package's lot code — a multidigit number on the bottom of a container of Similac PM 60/40, Similac, Alimentum and EleCare powdered infant formula — and do not use the product if all three conditions below are met:
- the first two digits of the code are 22 through 37; and
- the code on the container contains K8, SH or Z2; and
- the expiration date is 4-1-2022 (APR 2022) or later
Additionally, Abbott has recalled cans of Similac PM 60/40 package features a lot code of 27032K80 and cases featuring a lot code of 27032K800.
You can also enter your product lot code on the company’s website to check if it is part of the recall.
How many babies have been affected?
The FDA investigation found four reports of Cronobacter sakazakii infections in infants and one complaint of a Salmonella newport infection in an infant. The illnesses occurred in Minnesota, Ohio and Texas between Sept. 16, 2021, and Jan. 4, 2022.
The agency added that Cronobacter infections may have contributed to the deaths of two infants. It is unclear whether the recalled baby formulas were the cause of the infections.
In a statement to TODAY, Abbott wrote: "The cases are under investigation and at this time the cause of the infants’ infections have not been determined. All infant formula products are tested for Cronobacter sakazakii, Salmonella and other pathogens and they must test negative before any product is released. In addition, retained samples related to the complaints for Cronobacter sakazakii tested negative for Cronobacter sakazakii. And the retained sample related to the complaint for Salmonella tested negative for Salmonella."
What are the symptoms of Cronobacter sakazakii and Salmonella newport infections in infants?
Symptoms include poor feeding, irritability, temperature changes, jaundice, grunting breaths, abnormal movements, lethargy, rash or blood in the urine or stool, according to the FDA.
If your infant is experiencing symptoms related to Cronobacter or Salmonella infection, contact your child’s health care provider immediately.