Cronobacter: CDC Find No Connection to Infant Formula

There is no evidence linking four ongoing Cronobacter sakazakii infections in infants across four states, the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) announced in a joint news release Friday.

Based on test results to date, there is no need for a recall of infant formula and parents may continue to use powdered infant formula, following the manufacturer’s directions on the printed label.

The ongoing investigation includes laboratory testing of various types and brands of powdered infant formula, nursery water and, when available, clinical samples from the infants. The investigation also includes the inspection of manufacturing facilities for infant formula and nursery water.

The following results have been confirmed from completed laboratory tests, although additional lab results are pending release:

• CDC’s laboratory conducted DNA fingerprinting of the bacteria from two recent cases of Cronobacter infection in infants (Missouri and Illinois). The results show that the Cronobacter bacteria differ genetically, suggesting that they are not related. (Bacteria from cases in Oklahoma and Florida are not available for analysis.) 

• CDC laboratory tests of samples provided by the Missouri Department of Health and Senior Services found Cronobacter bacteria in an opened container of infant formula, an opened bottle of nursery water and prepared infant formula.  It is unclear how the contamination occurred.

• The FDA tested factory sealed containers of powdered infant formula and nursery water with the same lot numbers as the opened containers collected from Missouri and no Cronobacter bacteria were found.

The FDA has inspected the facilities that manufactured the infant formula and the nursery water that tested positive for Cronobacter bacteria.  Those manufacturers have programs that test their products before they are distributed.  The lots in question were tested and found negative for Cronobacter. There is currently no evidence to conclude that the infant formula or nursery water was contaminated during manufacturing or shipping.

The FDA, CDC and state agencies continue to investigate the cause of the infections using epidemiological and laboratory methods.  Currently CDC and FDA laboratories are testing infant formula, water and other environmental samples related to the ill infants from Illinois and Oklahoma; the results are pending.  Additional steps include: completion of inspections of manufacturers, additional laboratory testing of samples, and additional DNA fingerprinting investigation.