Feb. 18, 2022 — The FDA says parents should not use three powdered baby formulas — Similac, Alimentum, and EleCare — that were made at an Abbott factory in Sturgis, MI, and are linked to reports of bacterial infections in four infants, including one who died.
Abbott is voluntarily recalling those formulas. More information about the recall can be found on the company’s website.
The formula should not be used if the first two digits of the product code are 22 through 37; the code on the container contains K8, SH, or Z2; and the expiration date is April 1, 2022, or later, the FDA said in a news release.
“As a result of the ongoing investigation, along with the U.S. Centers for Disease Control and Prevention and state and local partners, the FDA is alerting consumers to avoid purchasing or using certain powdered infant formula products produced at this facility,” the agency said.
The FDA is investigating four cases of infant illness related to the formulas, three for Cronobacter sakazakii and one forSalmonellaNewport, in Minnesota, Ohio, and Texas. The FDA didn’t say where the infant death occurred.
“All four cases related to these complaints were hospitalized, and Cronobacter may have contributed to a death in one case,” the FDA said.
Cronobacter bacteria can cause severe infections, including sepsis and meningitis, the FDA said. Symptoms of sepsis and meningitis in babies may include poor feeding, crankiness, temperature changes, jaundice, and abnormal movements, the agency said.
Salmonella bacteria can cause digestive illnesses. Symptoms include diarrhea, a fever, and belly cramps.
In a news release posted on the FDA website, Abbott said the company tested for the bacteria and found evidence of Cronobacter sakazakii “in non-product contact areas” at the Sturgis factory but found no evidence of Salmonella Newport. No distributed product has tested positive for either of those bacteria, Abbott said.
“We’re taking this action so parents know they can trust us to meet our high standards, as well as theirs,” said Joe Manning, executive vice president, nutritional products, at Abbott. “We deeply regret the concern and inconvenience this situation will cause parents, caregivers and health care professionals.”
“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.
“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.”