The Centers for Disease Control and Prevention and the U.S. Food and Drug Administration are investigating reports and complaints of infant disease related to formula from the Abbott facility in Sturgis, Michigan.
The FDA said Monday that a child consumed Similac PM 60/40 before contracting Cronobacter sakazakii and dying. The agency said the infection “may have been the cause of the child’s death”.
Abbott recalled the formula with batch code 27032K800 on Monday. The company said that no product distributed had tested positive for Cronobacter sakazakii.
“We appreciate the trust our parents place in high-quality and safe nutrition, and we will do whatever it takes to maintain that trust,” Abbott said in a statement emailed to CNN on Monday.
Other Abbott products should not be used if the first two digits of the batch code are 22 to 37; the container code contains K8, SH or Z2; and the expiration date is April 1, 2022 or later.
“The withdrawal does not include liquid formula products,” the FDA said. “Users must continue to use all products not included in the downloads.”
Cronobacter bacteria can cause severe, life-threatening infections or inflammation of the membranes that protect the brain and spine. Symptoms include unusual movements, wheezing, irritability, jaundice, lethargy, poor diet, rash, temperature changes, or blood in the urine or stool, according to the FDA.
The reports come as the United States faces a shortage of baby formula. Manufacturers have said they are producing at full capacity and making more formula than ever, but that is still not enough to meet current demand.
CNN’s Katherine Dillinger contributed to this report.