FDA updated its report today. Here are the key facts:
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
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.
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.
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.
I still have questions:
Question 1: Given that illnesses began in early September 2021, did that fact that Cronobacter sakazakii is only reportable in Minnesota hamper the investigation and delay the outbreak announcement and recall?
Question 2: With illnesses occurring (that we know about) beginning September 6 2021 to at least December 18, 2021, why was the first recall not announced until February 17, 2022 and the expanded recall on February 28, 2022?
Question 3: Why were no FDA inspections performed at the Abbott facility for two years before the outbreak and recall? COVID-19?
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 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.
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.
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:
More information on Cronobacter and infant formula is available on CDC’s website.
Recalled powdered infant formulas have the potential to be contaminated with Cronobacter, a bacterium that can cause severe foodborne illness primarily in infants. Cronobacter infections are rare but are especially high risk for newborn infants (see symptoms below).
Cronobacter bacteria can cause severe, life-threatening infections (sepsis) or meningitis (an inflammation of the membranes that protect the brain and spine). Symptoms of sepsis and meningitis may include poor feeding, irritability, temperature changes, jaundice (yellow skin and whites of the eyes), grunting breaths, and abnormal body movements. Cronobacter infection may also cause bowel damage and may spread through the blood to other parts of the body.
If your child is experiencing any of these symptoms, you should notify your child’s healthcare provider and seek medical care for your child immediately. Healthcare providers and health departments are encouraged to report any confirmed cases of Cronobacter sakazakii to CDC.