FDA Expands Recall of Abbott Baby Formula

March 1, 2022

The U.S. Food and Drug Administration expanded its recall of Abbott baby formula after a second infant became sick with a bacterial infection and died after consuming formula.

The newest recall is for Similac PM 60/40 formula, a specialty formula for infants who need lowered mineral intake, the FDA said in a Monday news release. It comes from the same Sturgis, MI., factory where other recalled formulas were made, the FDA said.

In the latest case, the baby who consumed Similac PM 60/40 formula became infected with Cronobactersakazakii and died, the FDA said, noting that the infection “may have been a contributing cause of death for this patient.” Details about the location and date of the death were not released.

“At this time, Similac PM 60/40 with lot code 27032K80 (can) / 27032K800 (case) are the only type and lots of this specialty formula being recalled,” the FDA said.

​​“This case is under investigation, and at this time the cause of the infant’s Cronobacter sakazakii infection has not been determined,” Abbott said on its website. “We want to extend our heartfelt sympathies to the family.”

Abbott said no distributed product has tested positive for the presence of Cronobacter sakazakii and recently tested product samples of Similac PM 60/40 from the designated lot numbers were negative for the bacteria.

With the newest case, a total of five infants are known to have gotten sick and two have died after consuming Abbott formula.

In mid-February, the FDA said parents should stop using three powdered baby formulas — Similac, Alimentum, and EleCare — that were made at the Sturgis factory that were linked to reports of bacterial infections in infants.

For the earlier recall, the FDA said formula should not be used if all three of these conditions are met: 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.

To find out if your formula has been recalled, go to this website and enter the product code on the bottom of the package.