The Food and Drug Administration on Monday announced that Abbott Nutrition would voluntarily recall certain batches of its Similac powdered infant formula after a second infant death.
The FDA had, in mid-February, warned parents not to use three popular powdered infant formulas – certain lots of Similac, Alimentum and EleCare with expiration dates of April 1, 2022, or later – manufactured at an Abbott plant in Michigan due to possible bacterial contamination.
At the time, the agency said it was investigating four reports of infants who were hospitalized after consuming formula manufactured at the plant, including one who died. The agency said one of the cases involved salmonella and three involved Cronobacter sakazakiim, a rare but dangerous germ that can cause blood infections and other serious complications.
Officials on Monday said they had identified a fourth case of cronobacter in an infant after being exposed to formula from the Abbott facility. That infant was hospitalized and later died. All five infections – four caused by cronobacter and one by salmonella – led to hospitalizations, and the former may have contributed to death in two patients.
In response, Abbott Nutrition on Monday recalled additional Similac PM 60/40 products with the lot code 27032K800, which is a “specialty formula for certain infants who would benefit from lowered mineral intake and was not included in the previous recall,” per the FDA.
“This case is under investigation, and at this time the cause of the infant’s Cronobacter sakazakii infection has not been determined,” a statement from Abbott Nutrition read in part. “We want to extend our heartfelt sympathies to the family.”
The FDA initiated an investigation after the initial reports of infant illness, inspecting Abbott’s plant in Sturgis, Michigan, where environmental samples tested positive for the Cronobacter bacteria. Inspectors also uncovered potential manufacturing problems, and past records showing the destruction of formula due to bacterial contamination.
The FDA said it is working with federal and local authorities in Minnesota, Ohio and Texas — the states where the infant infections were reported. The infections occurred between Sept. 16, 2021 and Jan. 4, 2022.
The potentially-contaminated batches of specialty Similac formula were shipped around the United States and to Israel. Concerned parents can search their products’ lot codes on Abbott’s website to see if they are included in the recall.
