Abbott Nutrition, a popular baby-food manufacturer, announced on Thursday that it was voluntarily recalling three types of infant formula after four babies became sick with bacterial infections after consuming the products.
The recall includes select lots of Similac, Alimentum and EleCare formulas that were manufactured at an Abbott facility in Sturgis, Mich. It comes after the Food and Drug Administration received four consumer complaints of bacterial infections related to the formulas.
Three of the complaints concerned Cronobacter sakazakii, a bacterium that can cause severe, life-threatening infections or inflammation of the membranes that protect the brain and spine. Cronobacter infection may also cause bowel damage and may spread through the blood to other parts of the body, according to the F.D.A.
The F.D.A. had posted a recommendation on Thursday to parents warning them about the products after illnesses in Minnesota, Ohio and Texas resulted in the hospitalization of four infants. The bacterium may have contributed to a death in one case, the agency said.
“We value the trust parents place in us for high quality and safe nutrition and we’ll do whatever it takes to keep that trust and resolve this situation,” Vicky Assardo, the senior director of global public affairs at Abbott Nutrition, said in a statement on Friday night.
The recall, which comes during a drastic baby-food shortage, affects certain lots of Similac, Alimentum and EleCare with expiration dates of April 1, 2022, or later. Products affected by the recall will also have a long sequence of numbers on the bottom of the container that starts with the first two digits 22 through 37, and contains K8, SH or Z2.
The recall does not apply to Abbott products manufactured in other facilities, the company said.
In its announcement, Abbott did not specify how many units the recall affected, but Similac baby formulas are highly popular in the United States and abroad.
In its statement announcing the recall, Abbott said that it conducts “routine testing for Cronobacter sakazakii and other pathogens.”
In tests of the Sturgis facility, the company said, it “found evidence of Cronobacter sakazakii in the plant in non-product contact areas,” but no evidence of Salmonella Newport, the bacterium cited in the fourth consumer complaint.
“No distributed product has tested positive for the presence of either of these bacteria,” Abbott said.
But the F.D.A said it had initiated an on-site inspection of the plant in which environmental samples tested positive for Cronobacter. Inspectors have also uncovered potential manufacturing problems, and a review of internal records revealed the company’s past destruction of product because of bacterial contamination, the agency said.
Frank Yiannas, the F.D.A. deputy commissioner for food policy and response, said he was “deeply concerned” about the reports, since formula is a “product used as the sole source of nutrition for many of our nation’s newborns and infants.”
The F.D.A is working with the Centers for Disease Control and Prevention along with federal and local authorities in Minnesota, Ohio and Texas in its investigation.
The F.D.A recommends that parents and caregivers of infants who have used the recalled products contact their child’s health care provider if they are concerned about the health of their child should.