Safety Report: Abbott Powder Infant Formula - recalled due to Cronobacter & Salmonella, USA

United States

*Update* March 07, 2022
EXPANDED: Abbott is voluntarily recalling one lot of Similac PM 60/40 (Lot # 27032K80 (can) / Lot # 27032K800 (case)) manufactured in Sturgis, Michigan. This is in addition to lots of Similac®, Alimentum® and EleCare® powder formula that were voluntarily recalled on Feb. 17. The action comes after learning of the death of an infant who tested positive for Cronobacter sakazakii and who we were informed had consumed Similac PM 60/40 from this lot. This case is under investigation, and at this time the cause of the infant’s Cronobacter sakazakii infection has not been determined.

Feb 17th, 2022
The FDA announced the recall of Abbott powder formulas, including Similac, Alimentum and EleCare manufactured in Sturgis, Mich., one of the company's manufacturing facilities. The recall does not include any metabolic deficiency nutrition formulas.

Abbott is voluntarily recalling these products after four consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants who had consumed powder infant formula manufactured in this facility. Additionally, they conduct routine testing for Cronobacter sakazakii and other pathogens in our manufacturing facilities. During testing in Sturgis, Mich., facility, they found evidence of Cronobacter sakazakii in the plant in non-product contact areas. They found no evidence of Salmonella Newport. This investigation is ongoing.

Importantly, no distributed product has tested positive for the presence of either of these bacteria, and we continue to test. All finished products are tested for Cronobacter sakazakii, Salmonella Newport and other pathogens and they must test negative before any product is released. Additionally, retained samples related to the three complaints for Cronobacter sakazakii tested negative for Cronobacter sakazakii. And the retained sample related to the complaint for Salmonella Newport tested negative for Salmonella Newport.

While Abbott's testing of finished product detected no pathogens, they recalled the powder formula manufactured in this facility with an expiration of April 1, 2022, or later. No Abbott liquid formulas, or nutrition products from other facilities are impacted by the recall.

Cronobacter sakazakii is commonly found in the environment and a variety of areas in the home. It can cause fever, poor feeding, excessive crying or low energy as well as other serious symptoms. It's important to follow the instructions for proper preparation, handling and storage of powder formulas.

What parents and caregivers should do: the products under recall have a multidigit number on the bottom of the container starting with the first two digits 22 through 37, contains K8, SH, or Z2 and with an expiration date of April 1, 2022, or after. To find out if the product you have is included in this recall, check the link below. Some product was distributed to countries outside the U.S.

Company name: Abbott
Brand name: Similac, Alimentum, and EleCare
Product recalled: Powder Infant Formula
Reason of the recall: Consumer complaints regarding Cronobacter sakazakii, Salmonella Newport.
FDA Recall date: February 17, 2022

Check the full recall details on www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/abbott-voluntarily-recalls-powder-formulas-manufactured-one-plant

Source: FDA