The U.S. Food and Drug Administration (FDA) issued a warning this week about several popular baby formulas made by Abbott Laboratories after reported illnesses across the United States.
Chicago-based Abbott Laboratories said it is recalling its Similac, Alimentum, and EleCare formulas that were manufactured in its Sturgis, Michigan, plant, according to a statement posted Thursday.
The FDA announced it is investigating the matter, saying there have been reports of Cronobacter sakazakii and Salmonella Newport bacterial infections associated with the products.
“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, in a statement Thursday.
The official added: “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.”
So far, four known illnesses from the bacteria have been reported, and the bacteria from the formula may have “contributed to a death” in one case, the FDA said. Those illnesses were reported in Ohio, Texas, and Minnesota.
Products made at the factory in Sturgis were distributed across the United States and were likely exported to other countries, the FDA said.
“Products that do not contain the information listed above are not impacted,” the health regulator added. “The FDA advisory does not include liquid formula products or any metabolic deficiency nutrition formulas. Consumers should continue to use all products not covered by the advisory.”
Abbott, meanwhile, said that it tests for pathogens including Salmonella and Cronobacter before its products are distributed and sold.
“We know parents depend on us to provide them with the highest quality nutrition formulas,” Joe Manning, executive vice president of nutritional products at Abbott, said in a statement. “We’re taking this action so parents know they can trust us to meet our high standards, as well as theirs.”
Health agencies say that Cronobacter can cause severe, life-threatening infections, including inflammation of membranes around the spine and brain. Among infants, such infections can be deadly, says the Centers for Disease Control and Prevention. Salmonella can also cause digestive sickness and fever.
According to Abbott, products that were recalled have a code in which the first two digits are 22 through 37. The code also contains K8, SH, or Z2, and the products have an expiration date of April 1, 2022, or later.