Public Health Advisory : Recall of Infant Formulas

Abbott is initiating a 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 firm conducts routine testing for Cronobacter sakazakii and other pathogens in its manufacturing facilities. During testing in the their 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 the firm continues to test. 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, 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.

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

For further information: Abbott Media: Vicky Assardo, (224) 668-1505; Jonathon Hamilton, (224) 667-8646; Ellen Wichman, (224) 667-8522; Spanish-speaking media in U.S.: John Koval, (224) 668-5355; Spanish-speaking media outside the U.S.: Jorge Solorzano, +52 55-3333-7604; Abbott Financial: Laura Dauer, (224) 667-2299

The Public Health and Food Protection Program is requesting all local health departments to contact retail food establishments within their jurisdictions that are likely to sell the above products and request them to immediately remove these products from their shelves.  PHFPP will issue a follow up message to you if FDA requests additional assistance or provides any updates.