Baby Formula Recall

Abbott Laboratories issued a baby formula recall for 26 Similac, 10 Alimentum and 13 EleCare varieties of formula. The recalls are related to an investigation of Cronobacter bacteria contamination that potentially led to the illness and death of infants.

Last Modified: March 1, 2023
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Why Have Abbott Baby Formulas Been Recalled?

Abbott issued a voluntary recall for certain lots of its baby formulas because of reports that babies got sick from Cronobacter sakazakii infection. All of the infected babies were hospitalized and two died.

Cronobacter infections are especially dangerous for newborns, though they are rare. The bacteria can cause life-threatening blood infections (sepsis) and swelling in the membranes surrounding the spinal cord and brain (meningitis).

In June 2022, the U.S. Food and Drug Administration received another report of an infant death that occurred in January and could be linked to bacterial infection from Abbott’s baby formula.

Parents have been filing baby formula lawsuits against formula manufacturers Abbott and Mead Johnson, but these are unrelated to the Abbott Cronobacter recall. These lawsuits allege that Abbott and Mead Johnson knew their cow’s milk baby formulas could increase the risk of necrotizing enterocolitis or NEC, a potentially fatal intestinal disease, in premature babies.

Which Baby Formulas Are Recalled?

In February 2022, Abbott Laboratories recalled certain lots of its Similac, EleCare and Alimentum baby formulas manufactured at its Sturgis, Michigan, factory. The company recalled the lots for potential bacterial contamination.

The FDA is still evaluating the findings of an Abbott facility inspection it completed in March 2022. Investigators found five different strains of Cronobacter sakazakii at the facility, but samples of product collected by the FDA were negative for Cronobacter.

The following products are included in the recall:

Similac Products
  • Abbott Similac 360 Total Care Infant Formula with Iron
  • Abbott Similac Advance
  • Abbott Similac Advance Step-1
  • Abbott Similac Advance Step-2
  • Abbott Similac Advance Infant Formula with Iron
  • Abbott Similac Human Milk Fortifier
  • Abbott Similac Organic
  • Abbott Similac Organic with A2 Milk Infant Formula with Iron
  • Abbott Similac Organic with A2 Milk Toddler Drink
  • Abbott Similac Organic Toddler with A2 Milk Infant Formula with Iron
  • Abbott Similac Pro-Advance
  • Abbott Similac Pro-Advance Infant Formula with Iron
  • Abbott Similac Pro-Sensitive Infant Formula with Iron
  • Abbott Similac Pro-Total Comfort Infant Formula with Iron
  • Abbott Similac Sensitive
  • Abbott Similac Sensitive Infant Formula with Iron
  • Abbott Similac Sensitive Lactose Sensitivity
  • Abbott Similac for Supplementation
  • Abbott Similac For Spit Up Infant Formula with Iron
  • Abbott Similac Total Comfort
  • Abbott Similac Total Comfort Infant Formula with Iron
  • Abbott Similac EleCare HMO
  • Abbott Similac EleCare
  • Abbott EleCare Similac Gold
  • Abbott EleCare Similac
  • Abbott Similac PM 60/40 - only lot code 27032K80 (can) / 27032K800 (case)
Alimentum Products
  • Abbott Infant Formula Powder
  • Abbott Similac Alimentum
  • Abbott Similac Alimentum Allergies & Colic Hypoallergenic Infant Formula
  • Abbott Similac Alimentum with 2'-FL HMO
  • Abbott Similac Alimentum Eye Q Plus
  • Abbott Similac Alimentum HMO
  • Abbott Alimentum HMO
  • Abbott Similac Alimentum infant formula
  • Abbott Similac Alimentum Infant Formula with Iron
  • Abbott Similac Alimentum Toddler Drink
EleCare Products
  • Abbott EleCare
  • Abbott EleCare Amino Acid-Based Powder Infant Formula with Iron
  • Abbott EleCare Infant Formula Unflavoured
  • Abbott EleCare Junior Vanilla
  • Abbott EleCare Jr Similac Vanilla
  • Abbott EleCare Jr Amino Acid-Based Nutrition Powder Unflavored
  • Abbott EleCare Jr Amino Acid-Based Nutrition Powder Banana
  • Abbott EleCare Jr Amino Acid-Based Nutrition Powder Chocolate
  • Abbott EleCare Similac
  • Abbott EleCare Similac Gold
  • Abbott Similac EleCare HMO
  • Abbott Similac EleCare
  • EleCare LCP Hypoallergenic

The Abbott facility which produces the recalled baby formula also makes other special infant medical foods that have not been included in the recall. These products haven’t been recalled because the FDA has determined that medical conditions may worsen without them.

Nevertheless, the agency warns that there may be some risk of Cronobacter contamination with these products and recommends parents check with their medical provider for alternatives.

Is your premature baby suffering from necrotizing enterocolitis (NEC) after being fed Similac or Enfamil?

Checking Your Baby Formula

Not all of the lots from the listed brands above are part of the recall, and you can check your baby formula package to see if it’s included in the recall.

Check to see if the first two digits of the code printed on the bottom of the container are 22 through 37 and if the code contains K8, SH or Z2. Look to see if the expiration date listed is April 2022 or later. The recalled products have all three of these conditions.

Powder Infant Formation container with Product Coding

Parents or caregivers can also enter the code on Abbott’s website to check if their formula is recalled. The FDA warns parents and caregivers not to use any Similac, EleCare or Alimentum formulas included in the recall.

What to Do If Your Baby Consumed Recalled Formula

If your baby consumed recalled formula, the FDA recommends stopping its use and asking your pediatrician about switching formulas. Watch for symptoms of potential Cronobacter infection, including: Irritability, jaundice, changes in temperature, poor feeding, grunting breaths, excessive crying or abnormal body movements.

If your baby shows any Cronobacter infection symptoms, contact your pediatrician or seek medical attention right away. You can fill out a MedWatch form online to report an illness or baby formula side effect to the FDA or call a Consumer Complaint Coordinator.

Mothers who have been supplementing breastfeeding with formula may be able to exclusively breastfeed. When it comes to choosing breastfeeding or formula, experts agree breast milk is preferred for babies.

Alternatives to Recalled Baby Formula

Parents or caregivers should ask their baby’s medical provider for alternatives to recalled baby formula. These include other store or name brand formulas that have not been recalled. The Abbott baby formula recall has led to a formula shortage, and the company has increased production at its other plants to try and make up for the demand.

Breastfeeding is always a great alternative to formula feeding, but if a mother isn’t producing her own milk or can’t breastfeed, parents and caregivers may decide to try human milk banks. Typically, hospitals receive priority and supplies may be low, but individuals may contact a milk bank for pasteurized donor human milk. Check the Human Milk Banking Association of America for a donor bank in your state.

It may be tempting to try and make homemade baby formula from recipes you find online, but experts say it’s dangerous because the recipes might not be safe and won’t provide adequate nutrition. Don’t dilute formula you currently have to make it last longer. This could also result in lack of nutrients for the baby and result in severe, life-threatening consequences.

Don’t buy baby formula from third party distributors online, especially if it’s from outside the U.S. because the formula may be counterfeit or not follow the FDA’s guidelines for proper nutrition.

Please seek the advice of a medical professional before making health care decisions.