All cases are reported to have consumed powdered infant formula produced from Abbott Nutrition’s Sturgis, MI facility. These complaints include three reports of Cronobacter sakazakii infections and one report of Salmonella Newport infection in infants.
The FDA said all four cases related to these complaints were hospitalized and Cronobacter may have contributed to a death in one case. The cases were in Minnesota, Ohio, and two in Texas.
The FDA has initiated an onsite inspection at the facility. Findings to date include several positive Cronobacter results from environmental samples taken by FDA, and adverse inspectional observations by FDA investigators. A review of the firm’s internal records also indicate environmental contamination with C. sakazakii and the firm’s destruction of product due to the presence of Cronobacter.
On February 17, Abbott Nutrition initiated a voluntary recall of certain powdered infant formulas. Products made at the Sturgis facility can be found across the US and were likely exported to other countries as well. Canadian health officials have also issued a recall warning.
The FDA is advising consumers not to use recalled Similac, Alimentum, or EleCare powdered infant formulas. Recalled products can be identified by the 7 to 9 digit code and expiration date on the bottom of the package. Products are included in the recall if all of these conditions are met: the first two digits of the code are 22 through 37 and the code on the container contains K8, SH, or Z2, and the expiration date is 4-1-2022 (APR 2022) or later.
The recall does not include liquid formula products or any metabolic deficiency nutrition formulas.
According to the company, recalled products were distributed to the following countries:
Australia, Bahrain, Barbados, Bermuda, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, Egypt, Guam, Guatemala, Hong Kong, India, Indonesia, Israel, Jordan, Kuwait, Lebanon, Malaysia, Mexico, New Zealand, Oman, Peru, Puerto Rico, Qatar, Saudi Arabia, Singapore, South Africa, Sudan, Taiwan, Thailand, UAE, UK, and Vietnam ANI South
Abbott said its recall does not include any metabolic deficiency nutrition formulas.
As part of Abbott's quality processes, the company said it conducts routine testing for C. sakazakii and other pathogens in its manufacturing facilities. During testing in the Sturgis, Mich., facility, Abbott said it found evidence of C. sakazakii in the plant in non-product contact areas, but found no evidence of Salmonella Newport. The investigation is ongoing.
Abbott added no distributed product has tested positive for the presence of either of these bacteria, and it continues to test.
It said all finished products are tested for C. 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 C. sakazakii tested negative for C. 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 said it is recalling the powder formula manufactured in the facility, which has 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.
C. 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."
Some product was distributed to countries outside the US.
While Chinese authorities said the affected formula products were not offered directly in China, China Customs has advised anyone who purchased them through cross-border e-commerce should stop using them. Authorities in Singapore, Saudi Arabia, Oman and Bahrain have issued similar warnings.