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

The Abbott Nutrition facility that produces recalled infant formulas also produces all Abbott Nutrition metabolic and other medical specialty infant formulas for infants with inborn errors of metabolism and other medical needs, as well as medical foods. These products, with the exception of one lot of Abbott Similac PM 60/40, have not been recalled because the FDA has determined that the risk of not having these specialty products available could significantly worsen underlying medical conditions. These products are all produced in the Sturgis, MI facility.

The FDA wants to be sure that parents and caregivers who use these specialty products are aware that there may be some risk of Cronobacter contamination. If possible, parents and caregivers should work with their medical provider to consider whether comparable products may be appropriate. If comparable alternative products are not available or appropriate, parents and caregivers should take extra care to follow the CDC’s updated advice for parents on how to reduce the risk of Cronobacter contamination of formula during preparation of powdered product, whether that contamination comes from the product itself or from other contamination sources in the home. 

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 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

March 31, 2022

The U.S. Food and Drug Administration (FDA), along with the Centers for Disease Control and Prevention (CDC) and state and local partners are investigating consumer complaints and/or reports, received from 9/20/2021 to 1/11/2022, of infant illness related to products from Abbott Nutrition’s Sturgis, MI, facility. The four ill patients are reported to have consumed powdered infant formula produced from Abbott Nutrition’s Sturgis, MI, facility.

The FDA investigators at the Abbott Nutrition facility in Sturgis, MI, collected numerous product and environmental samples:

• Five environmental subsamples collected from the Sturgis, MI facility were positive for Cronobacter sakazakii; four were detected by the FDA and one was detected through firm-initiated testing. The positive Cronobacter sakazakii environmental samples at the Sturgis, MI, facility have been analyzed using Whole Genome Sequencing (WGS), revealing five different strains of Cronobacter sakazakii.

• Product samples collected by FDA at the facility were analyzed for Cronobacter by FDA and were found negative.

There are no additional FDA samples pending analysis at this time. On March 18, 2022, the FDA inspection at the Abbott Nutrition facility in Sturgis, MI, was completed and a Form 483 was issued that included four observations. The inspectional observations in this Form 483 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 we continue to evaluate the 2022 inspectional findings.

At this time, CDC has completed laboratory testing for two clinical samples received related to this investigation. Analysis performed by WGS did not find these samples from patients to be a genetic match to the multiple strains of Cronobacter found in the environmental samples obtained from Abbott Nutrition’s Sturgis, MI, facility or to any other clinical isolates in the National Center for Biotechnology Informatics (NCBI) database.

The FDA is working with Abbott Nutrition to better assess the impacts of the recall and understand production capacity at other Abbott facilities that produce some of the impacted brands. We are also working with Abbott Nutrition on safe resumption of production at the Sturgis, MI, facility. We will continue discussion with Abbott Nutrition and other infant formula manufacturers and consider all tools available to support the supply of infant formula products. We are also partnering with the United State Department of Agriculture’s Food and Nutrition Service (FNS) to monitor the impact of the recall on The Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) Program.

March 22, 2022

The 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. The FDA will take appropriate action in the future - if warranted - as we continue 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.

Once the immediate public health risk is minimized, the FDA will conduct a programmatic review to ensure the maximum effectiveness of agency programs and policies related to infant formula and special medical food complaints, illnesses, and recalls.

Conducting this review is a top priority for the FDA and will be done as efficiently as possible, and we can ensure this effort will not interfere with the immediate recall response activities. We will and must continue focusing on taking all steps possible to protect the health of those who rely on safe powdered infant formula.

March 15, 2022

To provide clarity about which products are included in the Abbott Nutrition recall, FDA is publishing a full list of recalled brands that have been included in the initial and expanded recall. Recalled products should no longer be available for sale, but if consumers have these products in their homes, they should check the lot code on the bottom of the package to determine if it is included in the recall.

The FDA is also providing additional information for parents and caregivers of infants receiving medical specialty infant formula and individuals using certain medical foods.

March 9, 2022

The Salmonella Newport illness previously included in this investigation of complaints and illnesses has been removed. In the early stages of this investigation, FDA included all consumer complaints of illness with exposure to products from the Sturgis, MI, facility. After further investigation, the FDA has determined that there is not enough information to definitively link this illness to powdered infant formula. CDC confirmed that this single Salmonella illness is not linked to an outbreak. The FDA and CDC are continuing to monitor for Salmonella cases and consumer complaints that may be related to this incident.

February 28, 2022

As of February 28, CDC has announced one additional illness of Cronobacter sakazakii with exposure to powdered infant formula produced at Abbott Nutrition’s Sturgis, MI facility. Cronobacter infection may have been a contributing cause of death for this patient. In total, this investigation includes four reports of Cronobacter sakazakii infections in infants (three from FDA complaints and one from a CDC case finding) and one complaint of a Salmonella Newport infection in an infant. All five (four Cronobacter infections and one Salmonella Newport infection) illnesses resulted in hospitalization and Cronobacter may have contributed to death in two patients.

The most recent patient was reported to have consumed Abbott Nutrition’s Similac PM 60/40 product with the lot code 27032K800 prior to Cronobacter sakazakii infection. FDA and CDC informed the firm of these findings and on February 28, 2022, Abbott Nutrition voluntarily recalled Similac PM 60/40 powdered infant formula with the lot code 27032K800. This is a specialty formula for certain infants who would benefit from lowered mineral intake and was not included in the previous recall. At this time, Similac PM 60/40 with lot code 27032K80 (can) / 27032K800 (case) are the only type and lots of this specialty formula being recalled.

This particular lot of Similac PM 60/40 was distributed to the U.S. and Israel. If your regular formula is not available, contact your child’s healthcare provider for recommendations on changing feeding practices.

We understand that infant formula is the sole source of nutrition for many infants and is an essential product. FDA is working with Abbott Nutrition to better assess the impacts of the recall and understand production capacity at other Abbott facilities that produce some of the impacted brands. We are also working with Abbott Nutrition on safe resumption of production at the Sturgis, MI facility. FDA is continuing to investigate and will update this advisory should additional consumer safety information become available.

February 25, 2022

As a result of the ongoing investigation, Abbott Nutrition has recalled certain powdered infant formula products and the FDA is advising consumers not to use recalled Similac, Alimentum, or EleCare powdered infant formulas produced in the Sturgis, MI facility.

We recognize that the Abbott Nutrition recall resulted in consumers seeking alternative brands or types of infant formula and that the recall has created new concerns about the availability of certain types of infant formula, particularly given the overall strains on supply chains experienced during the COVID-19 pandemic.

We understand that infant formula is the sole source of nutrition for many infants and is an essential product.

FDA is working with Abbott Nutrition to better assess the impacts of the recall and understand production capacity at other Abbott facilities that produce some of the impacted brands. We are also working with Abbott Nutrition on safe resumption of production at the Sturgis, MI facility. Throughout the pandemic, FDA has also been monitoring potential supply chain risks for this category of products and has been reaching out to infant formula manufacturers and their trade groups. As Abbott Nutrition was initiating its recall, FDA intensified this outreach to infant formula manufacturers to inquire about their capacity and potential impacts given this developing situation. We will continue discussion with Abbott Nutrition and other infant formula manufacturers and consider all tools available to support the supply of infant formula products.

We are also partnering with the United State Department of Agriculture’s Food and Nutrition Service (FNS) to monitor the impact of the recall on the WIC Program.

February 20, 2022

On 2/17/2022, Abbott Nutrition initiated a voluntary recall of certain powdered infant formulas. Products made at the Sturgis facility can be found across the United States and were likely exported to other countries/locations as well. Canadian health officials have also issued a recall warning.

February 17, 2022

The FDA, along with CDC and state and local partners are investigating four consumer complaints of infant illness related to products from Abbott Nutrition’s Sturgis, MI facility received from 9/20/2021 to 12/18/2021. All of the cases are reported to have consumed powdered infant formula (IF) 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. All four cases related to these complaints were hospitalized and Cronobacter 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 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.

FDA is issuing this advisory to alert consumers to avoid purchasing or using certain powdered infant formula produced in the Sturgis, MI facility.

This is an ongoing investigation and the firm is working with the FDA to initiate a voluntary recall of potentially affected product. FDA is continuing to investigate and will update this advisory should additional consumer safety information become available.