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The Food and Drug Administration (FDA) announced that Michigan-based Abbott is initiating a proactive, voluntary recall of powder formula that includes Similac, Alimentum, and EleCare.
In a press release, the FDA announced it is investigating multiple consumer complaints of Cronobacter sakazakii and Salmonella Newport infections that resulted in four infant illnesses and hospitalizations in three states.
Cronobacter may have contributed to a death in one case, according to the report.
According to the FDA, consumers have been advised not to use those products if: “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.”
Parents have been instructed to discard any affected formula by the FDA.
The agency said that as part of the process, they’ve been “conducting routine testing for Cronobacter sakazakii and other pathogens in (Abbott’s) manufacturing facilities,” and the investigation is ongoing.
“Importantly, no distributed product has tested positive for the presence of either of these bacteria, and we continue to test,” according to the company. "Abbott conducts extensive quality checks on each completed batch of infant formula, including microbiological analysis prior to release.”
According to the FDA, Cronobacter bacteria can cause life-threatening infections such as sepsis or meningitis.
“Symptoms of sepsis and meningitis may include poor feeding, irritability, temperature changes, jaundice (yellow skin and whites of the eyes), grunting breaths, and abnormal movements. Cronobacter infection may also cause bowel damage and may spread through the blood to other parts of the body," officials said.
"Parents and caregivers of infants who have used these products, and are concerned about the health of their child, should contact their child's health care provider.”
The recalled items were sold across the country.
"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,” FDA deputy commissioner for food policy and response Frank Yiannas said in a press release.
"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."
The complete announcement from the FDA can be found here.
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