Abbott Nutrition, a popular baby food manufacturer, announced on Thursday that it was voluntarily recalling to types of infant formula after one baby died and three others became ill with bacterial infections.
The recall includes formula sold under the Similac, Alimentum, and EleCare brands, all of which were produced at the same factory in Sturgis, Michigan. The company was alerted after four separate complaints reached the FDA, from Minnesota, Ohio, and Texas; the FDA then issued a warning to parents.
Upon investigation, it emerged that three of the complaints related to contamination with a bacteria called Cronobacter sakazakii which can affect the membranes of the brain, the spine, and the bowels. The fourth report concerned contamination with Salmonella Newport.
“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, senior director of global public affairs at Abbott Nutrition, said in a statement on Friday night.
The affected lots all expire on April 1, 2022 or later, and the numbers on the bottom of the containers all begin with the digits 22 through 37 and contain K8, SH, or Z2.
Abbott issued a statement claiming that it “found evidence of Cronobacter sakazakii in the plant in non-product contact areas,” and adding that it routinely tests for the bacteria of concern along with other pathogens and that it had found no evidence of any contamination with Salmonella Newport.
“No distributed product has tested positive for the presence of either of these bacteria,” Abbott said.
However, the FDA said in a statement that its own own-site inspection of the plant had led to the finding of several environmental samples that tested positive for Cronobacter. Inspectors apparently also uncovered potential manufacturing problems, and a review of the company’s records revealed the company’s past destruction of products due to bacterial contamination, the agency said.
The FDA is now working with the Centers for Disease Control and Prevention (CDC) along with federal and local authorities in Minnesota, Ohio and Texas in its investigation.