Abbott Powder Infant Formula - expanded recall due to consumer complaints regarding Cronobacter & Salmonella

United States

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.

Importantly, no distributed product has tested positive for the presence of Cronobacter sakazakii. Additionally, recently tested retained product samples of Similac PM 60/40 Lot # 27032K80 (can) / Lot #27032K800 (case) were negative for Cronobacter. 02.17.2022 Abbott initiated a proactive, voluntary recall of powder formulas, including Similac, Alimentum and EleCare, manufactured in Sturgis, Michigan, 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, as part of Abbott's quality processes, they conduct routine testing for Cronobacter sakazakii and other pathogens in their manufacturing facilities. During testing in the Sturgis, Michigan, facility, they found evidence of Cronobacter sakazakii in the plant in non-product contact areas. There was 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 they continue to test.

Abbott conducts extensive quality checks on each completed batch of infant formula, including microbiological analysis prior to release. All finished  infant formula powder products are tested for Cronobacter, Salmonella, and other pathogens, and they must test negative before the product is released. Additionally, retained samples related to the three complaints for Cronobacter sakazakii tested negative for Cronobacter. And the retained sample related to the complaint for Salmonella Newport tested negative for Salmonella.  While Abbott's testing of distributed product detected no pathogens, they are taking action by recalling the powder formula manufactured in this facility with an expiration of April 1, 2022, or later.

No Abbott liquid formulas are included in the recall, nor are powder formulas or nutrition products from other facilities. If your infant is experiencing symptoms related to Cronobacter or Salmonella infection, such as poor feeding, irritability, temperature changes, jaundice, grunting breaths, abnormal movements, lethargy, rash, or blood in the urine or stool; contact your health care provider for immediate care and report their symptoms.

Company name: Abbott
Brand name: Similac, Alimentum, and EleCare
Product recalled: Powder Infant Formula
Reason of the recall: Consumer complaints regarding Cronobacter sakazakii, Cronobacter Newport
FDA Recall date: March 07, 2022

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

Source: FDA