Category Archives: Food Inspections

On February 17, Abbott recalledexternal icon three brands of formula produced at its manufacturing facility in Sturgis, Michigan.

Recalled Similac, Alimentum, or EleCare powdered formula have all three of these conditions:

• First two digits of the code are 22 through 37, AND
• Code on the container contains “K8,” “SH,” or “Z2,” AND
• Use-by date is 4-1-2022 (APR 2022) or later.

To find out if the product you have is included in this recall, review these codes in the bottom of the package. See the recall noticeexternal icon for more information.

Do not feed your baby any recalled powdered formula.

• Check to see if your powdered formula is recalled using one of these three ways:
  • Compare the code and use-by date on the bottom of the package to the recall information.
  • Visit Abbott’s websiteexternal icon and type in the code on the bottom of the package.
  • Call 1-800-986-8540 and follow the instructions provided.
• If you have any recalled powdered formula, immediately stop feeding it to your baby and return it for a refund at the store where you bought it. You can also return it to Abbott.external icon
• If you can’t find the code on the powdered formula package, do not use it.
• Parents and caregivers should never dilute powdered infant formula (by adding more water than recommended or another solvent to it) and should not make or feed homemade infant formula to infants.
• Do not buy formula online that comes from outside the United States. This formula could be counterfeitexternal icon—for example, it might have a fake label with a wrong use-by date.
• If you get infant formula through WIC, call your local WIC clinic for more guidance. Also see:
  • WIC Infant Formula Recall Waivers | Food and Nutrition Service (usda.gov)external icon
  • Toll-Free Numbers for WIC State Agenciesexternal icon
  • USDA Contact Mapexternal icon

Contact your baby’s healthcare provider if:

• Your baby has symptoms of Cronobacter illness (fever and poor feeding, excessive crying, or very low energy).
• Your regular formula is not available, and you need recommendations on other ways to feed your baby.

• The first symptom of Cronobacter infection in infants (0–1 year old) is usually a fever, accompanied by poor feeding, excessive crying, or very low energy. Some infants may also have seizures. Infants with these symptoms should be seen by a medical provider as soon as possible.
• Cronobacter germs can cause a dangerous blood infection (sepsis) or make the linings surrounding the brain and spinal cord swell (meningitis). Infections in infants usually occur in the first days or weeks of life. Infants 2 months of age and younger are most likely to develop meningitis if they are infected with Cronobacter.

• If a Cronobacter infection is diagnosed by a laboratory culture, CDC encourages clinicians and laboratories to inform their local or state health department.
• Cronobacter can be detected in the blood or cerebrospinal fluid (CSF) of patients with meningitis or sepsis caused by these bacteria. Cronobacter bacteria grow on routine culture media and microbiological laboratories can detect Cronobacter from blood or CSF samples.
• CDC does not recommend testing infants for Cronobacter infection unless they have symptoms of meningitis or sepsis, even if they consumed recalled formula.
• CDC does not recommend testing stool for Cronobacter. Cronobacter infection does not typically cause diarrhea in infants.
• CDC does not recommend testing formula for Cronobacter contamination unless an infant has a diagnosed Cronobacter infection.

On February 10, 2022, CDC was notified of FDA’s investigation of consumer complaints of infant illness related to products from Abbott Nutrition in Sturgis, Michigan. These complaints include three reports of Cronobacter sakazakii infections and one report of Salmonella Newport infection in infants. CDC and FDA are conducting additional laboratory testing and investigation to better understand these cases.

The most recent investigation details are summarized below:

From September 16, 2021, to January 5, 2022, CDC received reports of three Cronobacter cases in infants that were later found to be linked to this ongoing investigation:

• Three infants in Minnesota, Ohio, and Texas consumed formula produced at the Sturgis, Michigan, facility before they got sick. Formula consumed included Similac Sensitive, Similac Pro-total Comfort, and Similac Advance. Cronobacter may have contributed to the death of an infant in Ohio.
• These are the same cases identified in the consumer complaints received by FDA.

On February 16, 2022, CDC asked clinicians and state and local health departments to provide information on other cases of Cronobacter associated with infant formula from November 2020 through the present. Since then, CDC has received reports of more possible cases of Cronobacter illnesses in infants who might have consumed recalled formula. CDC is investigating to determine if these cases are linked to formula products produced at the Abbott Nutrition facility in Sturgis, Michigan. CDC is performing whole genome sequencing on Cronobacter bacteria isolated from available patient samples to compare with the environmental samples taken at the facility to determine if there is any relation.

CDC’s routine outbreak surveillance has not detected an outbreak of Salmonella illnesses linked to the case reported to FDA.

Cronobacter sakazakii is a germ found naturally in the environment and can live in very dry places. The germs can live in dry foods, such as powdered infant formula, powdered milk, herbal teas, and starches. Cronobacter infection is not reportable in most states, meaning doctors are not required to report cases to their health department. Cronobacter illnesses are rare, but when infections happen, they can be deadly for infants. CDC typically receives reports of 2 to 4 infections in infants per year, but the total number of cases that occur in the United States each year is not known.

• At a production factory, Cronobacter could get into formula powder if contaminated raw materials are used to make the formula or if the formula powder touches a contaminated surface in the manufacturing environment.
• Powdered infant formula could also become contaminated at home or elsewhere after the container is opened. For example, Cronobacter could get into the formula if formula lids or scoops are placed on contaminated surfaces and later touch the formula or if the formula is mixed with contaminated water or in a contaminated bottle. See more information on how to safely prepare and store powdered infant formula.