02.28.2022 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. We want to extend our heartfelt sympathies to the family.
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.
Abbott (NYSE: ABT) is initiating a proactive, voluntary recall of 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, as part of Abbott's quality processes, the company conduct routine testing for Cronobacter sakazakii and other pathogens in their manufacturing facilities. During testing in the Sturgis, Mich., facility, evidence was found of Cronobacter sakazakii in the plant in non-product contact areas. No evidence of Salmonella Newport was found. This investigation is ongoing.
Importantly, no distributed product has tested positive for the presence of either of these bacteria, and testing continues. Abbott conducts extensive quality checks on each completed batch of infant formula, including microbiological analysis prior to release. 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, the company is 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.
"We know parents depend on us to provide them with the highest quality nutrition formulas," said Joe Manning, executive vice president, nutritional products, Abbott. "We're taking this action so parents know they can trust us to meet our high standards, as well as theirs. We deeply regret the concern and inconvenience this situation will cause parents, caregivers and health care professionals."
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, visit similacrecall.com and type in the code on the bottom of the package, or call +1-800-986-8540 (U.S.) and follow the instructions provided. No action is needed for previously consumed product. If you have questions about feeding your child, contact your healthcare professional.
Some product was distributed to countries outside the U.S. A list of these products can be found at similacrecall.com
Original recall and updates at FDA