The U.S. Food and Drug Administration (FDA) is investigating consumer complaints of Cronobacter sakazakii and Salmonella Newport infections. All of the infants in the cases are reported to have consumed powdered infant formula produced from Abbott Nutrition’s Sturgis, Michigan facility. As a result of the ongoing investigation, along with the U.S. Centers for Disease Control and Prevention (CDC) and state and local partners, FDA is alerting consumers to avoid purchasing or using certain powdered infant formula products produced at this facility. This is an ongoing investigation, and the firm is working with FDA to initiate a voluntary recall.
Abbott announced that the company initiated a voluntary recall of potentially affected products, including Similac, Alimentum, and EleCare powdered formulas manufactured in its Sturgis, Michigan facility. Products made at this facility can be found across the U.S. and were likely exported to other countries, as well. Canadian health officials have also issued a recall warning. Additional recall information is available on the FDA website. Parents and caregivers can also enter their product lot code on the company’s website to check if it is part of the recall.
The FDA is advising consumers not to use Similac, Alimentum, or EleCare powdered infant formulas if:
- The first two digits of the code are 22 through 37
- The code on the container contains K8, SH, or Z2
- The expiration date is 4-1-2022 (APR 2022) or later.
FDA is investigating complaints of four infant illnesses from three states. All four cases related to these complaints were hospitalized, and Cronobacter sakazakii may have contributed to a death in one case. FDA has initiated an onsite inspection at the facility. Findings to date include several positive Cronobacter sakazakii 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 Cronobacter sakazakii and the firm’s destruction of product due to the presence of Cronobacter.
“As this is a product used as the sole source of nutrition for many of our nation’s newborns and infants, the FDA is deeply concerned about these reports of bacterial infections,” said Frank Yiannas, FDA Deputy Commissioner for Food Policy and Response. “We want to reassure the public that we’re working diligently with our partners to investigate complaints related to these products, which we recognize include infant formula produced at this facility, while we work to resolve this safety concern as quickly as possible.”
Update, May 17, 2022: FDA filed a consent decree of permanent injunction with Abbott Nutrition, which is subject to court approval and entry.
Update, May 12, 2022: CDC announced that its investigation of of illnesses among infants who were reported to have consumed powdered infant formula products from Abbott Nutrition’s Sturgis, MI, facility is closed, with no additional cases identified as part of the investigation.
Update, May 3, 2022: While Abbott Nutrition conducts enhanced testing of stored product batches, FDA has informed Abbott Nutrition that the agency has no objection to the company immediately releasing product to individuals who need urgent, life-sustaining supplies of the specialty and metabolic formulas listed here, on a case-by-case basis.
Update, April 1, 2022: FDA confirmed the presence of five different Cronobacter sakazakii strains at the Abbott Nutrition production plant in Sturgis, Michigan. None of these strains, however, match the two available samples from sick infants. CDC conducted whole genome sequencing on the two available patient samples. FDA continues to urge consumers not to use Similac, Alimentum, or EleCare powdered infant formulas that match the identifying information included in the recall initiated by Abbott Nutrition.
Update, March 23, 2022: FDA is releasing the FDA Form 483s from three inspections conducted at Abbott Nutrition’s facility on Sept. 16–24, 2019, Sept. 20–24, 2021, and Jan. 31–March 18, 2022. The inspectional observations in these Form 483s do not constitute final FDA determinations of whether any condition was or is in violation of the Federal Food, Drug, and Cosmetic Act or any of its implementing regulations. FDA will take appropriate action in the future, if warranted, as it continues to evaluate the 2022 inspectional findings.
Important observations noted in the 2022 Form 483 include, but are not limited to:
- [Abbott Nutrition] did not establish a system of process controls covering all stages of processing that was designed to ensure that infant formula does not become adulterated due to the presence of microorganisms in the formula or in the processing environment.
- [Abbott Nutrition] did not ensure that all surfaces that contacted infant formula were maintained to protect infant formula from being contaminated by any source.
Update, March 1, 2022: Abbott Nutrition has expanded its recall due to the report of an additional death in this outbreak.
The most recent infant who died consumed Abbott Nutrition's Similac PM 60/40 product with the lot code 27032K800 prior to the infant’s Cronobacter sakazakii infection.
FDA and CDC informed the company of this, and Abbott Nutrition has voluntarily recalled the Similac product in question.