Drug Safety Alerts

Abbott Formulas Recall

2/18/2022

On February 18, 2022, Abbott issued a recall of certain powder formulas, including Similac®, Alimentum® and EleCare®. This recall was issued due to four consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants who had consumed powder infant formula manufactured in the Sturgis, Michigan, facility.

On February 28, 2022, Abbott issued another recall, of Similac® PM 60/40 powder. This recall was issued due to the death of an infant who tested positive for Cronobacter sakazakii after reportedly consuming Similac PM 60/40. According to Abbott, this case is under investigation, and at this time the cause of the infant’s Cronobacter sakazakii infection has not been determined.

No Abbott liquid formulas are impacted by this recall. Additionally, no powder formulas or nutrition products produced in any other facility are impacted by the recall.

This may represent a potential health hazard or safety risk to patients using products affected by these recalls.

Abbott has reported that during testing in its Sturgis, Michigan facility, it found evidence of Cronobacter sakazakii in the plant in non-product contact areas. Abbott has advised, however, that no distributed product has tested positive for the presence of either of Cronobacter sakazakii or Salmonella Newport, and that it conducts extensive quality checks on each completed batch of infant formula. Abbott has further advised that infant formula powder finished products are tested for Cronobacter sakazakii, Salmonella Newport and other pathogens and they must test negative before any product is released. 

While Abbott reports that its testing of finished 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, powder 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.

A list of the affected products is provided here.

Information on determining whether product is from an impacted lot number is available at similacrecall.com.

CVS Caremark Response: CVS Caremark is in the process of contacting patients and prescribers to advise them of this recall. We are encouraging patients who are using to contact their prescriber.

For more information, please call Abbott at 1-800-986-8540 or visit similacrecall.com.You may also call the U.S. Food and Drug Administration (FDA) consumer inquiry line at 1-888-INFO-FDA (1-888-463-6332) or visit https://www.fda.gov.