U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. Food
  3. Recalls, Outbreaks & Emergencies
  4. Outbreaks of Foodborne Illness
  5. FDA Investigation of Cronobacter Infections: Powdered Infant Formula (February 2022)
  1. Outbreaks of Foodborne Illness

FDA Investigation of Cronobacter Infections: Powdered Infant Formula (February 2022)

Do not use recalled Similac, Alimentum, or EleCare powdered infant formulas produced at Abbott Nutrition’s Sturgis, MI, facility

Spanish (Español)

If you want to check if your powdered formula is part of the recall, you can enter the product lot code on the bottom of your package on the company’s website.

If you have questions or need information about the recall, you can Submit Questions/Get Assistance.

If your infant is experiencing symptoms related to Cronobacter infection, such as poor feeding, irritability, temperature changes, jaundice, grunting breaths, or abnormal body movements; contact your health care provider to report their symptoms and receive immediate care.

To report a complaint or adverse event (illness or serious allergic reaction), visit Industry and Consumer Assistance.

Update on Infant Formula Supplies: The FDA has announced that it will exercise enforcement discretion with respect to the specific infant formula products, to increase infant formula supplies in the United States.

The U.S. Food and Drug Administration (FDA)’s Coordinated Outbreak Response and Evaluation (CORE) Network, along with the Centers for Disease Control and Prevention (CDC) and state and local partners investigated consumer complaints and/or reports received by FDA from 9/20/2021 to 2/24/2022, of illnesses among infants who were reported to have consumed powdered infant formula products from Abbott Nutrition’s Sturgis, MI, facility. Although CORE is no longer investigating this incident, the FDA established an Incident Management Group (IMG) on April 1, 2022, to continue to work on supply chain and food safety issues.

Recommendation

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 (see image below). Products are included in the recall if they have all three items below:

  • 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.

In addition to products described above, Abbott Nutrition has recalled Similac PM 60/40 with a lot code 27032K80 (can) / 27032K800 (case). At this time, Similac PM 60/40 with lot code 27032K80 (can) / 27032K800 (case) is the only type and lot of this specialty formula being recalled. Additional recall information for the initial recall is available on the FDA website. Parents can also enter their product lot code on the company’s website to check if it is part of the recall.

Certain specialty and metabolic formulas have been tested and released by Abbott Nutrition on a case-by-case basis. Parents and caregivers of infants receiving this specialty and metabolic formula should not reference the recall product description above, but instead should enter the product lot code found at the bottom of their package by using the “Check Lot Number” feature at the bottom of the company’s webpage or by calling Abbott Nutrition at 1-800-881-0876.

Additional Information for Parents and Caregivers:

The recalls do not include liquid formula products.

Parents and caregivers should never dilute infant formula and should not make or feed homemade infant formula to infants. Consumers should also avoid purchasing imported formula through online sales, as it has the potential to be counterfeit.

If your regular formula is not available, contact your child’s healthcare provider for recommendations on changing feeding practices.

If you get infant formula through WIC, do not throw the formula out. Instead, you should take it to the store for a refund and exchange or call the company at 1-800-986-8540 to help you. WIC recipients should be able to obtain a different brand of similar formula. Call your local WIC clinic for more guidance. Also see, https://www.fns.usda.gov/wic. 

Product Images

Sample Product Image from the FDA Investigation of Cronobacter and Salmonella Complaints about Powdered Infant Formula (February 2022)
Sample Product Image from the FDA Investigation of Cronobacter and Salmonella Complaints about Powdered Infant Formula (February 2022)
Sample Product Image from the FDA Investigation of Cronobacter and Salmonella Complaints about Powdered Infant Formula (February 2022)

Case Counts

Total Adverse Events: 4
Hospitalizations: 4
Reported Deaths: 2*
Illness Onset Date Range: 9/6/2021 – 1/4/2022
States with Adverse Events: MN (1), OH (2), TX (1)
Product Distribution: Nationwide and International
* Two deaths have been reported. Cronobacter infection may have contributed to the cause of death for both patients.

Useful Links

Additional Investigation Information

For Industry

For Consumers

Recalled Products

Additional Information for Parents and Caregivers of Infants Receiving Medical Specialty Infant Formulas and Individuals Using Certain Medical Foods

Following the voluntary recall and hold of certain powdered infant formula products produced at the Abbott Nutrition facility in Sturgis, MI, Abbott has committed to completing enhanced testing of stored product batches prior to making release determinations. While the FDA recognizes that Abbott has conducted standard product testing, there were a limited number of samples tested. Additionally, although finished product testing does not eliminate the risk of contamination, the enhanced testing will provide for a greater chance to detect Cronobacter sakazakii, if present; however, this enhanced level of testing will take additional time.

In the meantime, the FDA has informed Abbott Nutrition that the agency has no objection to the company immediately releasing product to individuals needing urgent, life-sustaining supplies of the specialty and metabolic formulas listed below on a case-by-case basis. The FDA is concerned that the risk of not having certain specialty and metabolic products available could significantly worsen underlying medical conditions and in some cases pose life-threatening risks for infants and individuals who rely on these products. In these circumstances, the benefit of allowing parents, in consultation with their healthcare providers, to access these products may outweigh the potential risk of bacterial infection.

Abbott has confirmed with the FDA that the company will consider release of these products on a case-by-case basis, depending on product availability and the severity of the individual’s need. Patients and caregivers seeking access to these products should contact Abbott directly to request that a product be made available to them by calling 1-800-881-0876.

It is important for parents and caregivers to understand that any products released on a case-by-case basis at this time were made at Abbott Nutrition’s Sturgis, MI, facility, and that the processes, procedures, and conditions that the FDA observed during its inspection of the Sturgis MI production facility from January 31 – March 18, 2022, raise concerns that powdered infant formula produced at this facility prior to the FDA’s inspection carry a risk of contamination. Therefore, those seeking access should consult with their healthcare provider in considering whether the benefit of consuming such product outweighs the potential risk of bacterial infection in the user’s particular circumstances. Parents and caregivers should continue to work with their medical provider to consider whether comparable alternative products may be appropriate.

Should product released on a case-by-case basis be used, parents and caregiver should pay close attention to the user’s health status and alert a healthcare provider immediately of any change in health status. In the meantime, the FDA is continuing to work diligently to ensure the safe resumption of production of infant formula at Abbott Nutrition’s Sturgis, Michigan facility.

It is important to note that these specialty infant formulas and medical foods are not sold in traditional retail stores. These products often require a prescription and are sold through specialty pharmacies and other specialty distribution channels such as medical product suppliers.

Parents and caregivers of infants and children using these products should contact their child’s health care providers if they have questions about the use of these products.

International Product Distribution for Recalled Products

The recall impacts Alimentum, EleCare, and Human Milk Fortifier for markets outside the U.S. No other Abbott Nutrition products distributed outside of the U.S. are affected by this recall. According to the firm, recalled products were distributed to the following countries/locations: 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, United Arab Emirates, United Kingdom, and Vietnam ANI South.

For additional information, international officials and customers can visit the company’s recall page for contact information.

Cronobacter Surveillance

Cronobacter infection surveillance is not handled the same way as infection with more common foodborne pathogens, such as Salmonella or E. coli O157:H7. Cronobacter is not nationally notifiable and not reportable except in one state, which means doctors and labs are not required to report cases to their health department. Because Cronobacter is not a nationally notifiable pathogen, FDA relies on consumer complaints of illness sent to the Agency and on health care providers informing FDA directly about infants with Cronobacter infections. In addition, because Cronobacter is not nationally notifiable, whole genome sequencing (WGS) is rarely performed on these isolates. To date, no outbreaks of Cronobacter have been detected using WGS.

When single cases of Cronobacter are reported, the FDA conducts a thorough review of each complaint, conducts sampling of products, and initiates inspections as appropriate. FDA collaborates with CDC, which has developed a detailed questionnaire specifically for Cronobacter infections that is often used by state health departments in instances of Cronobacter sakazakii infection.

Previous Updates

Who to Contact

Consumers who have symptoms should contact their health care provider to report their symptoms and receive care.

To report a complaint or adverse event (illness or serious allergic reaction), 
visit Industry and Consumer Assistance.

Follow us on X

Get Email Notifications on Outbreak Investigations

Get email updates delivered to your inbox.

Back to Top