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Why Is There a Recall on Baby Formula?

There have been several baby formula recalls involving different manufacturers since early 2022. These recalls were issued following reports of contaminated baby formula.

Most recently, on Dec. 11, 2022, baby formula company ByHeart voluntarily recalled five batches of its products after a third-party facility it uses for manufacturing tested positive for the harmful bacteria Cronobacter sakazakii. None of ByHeart’s distributed products have tested positive for bacteria, however, and the company hasn’t received complaints of illness.

Earlier in 2022, a major infant formula recall touched off a significant national baby formula shortage. On Feb. 17, 2022, Abbott launched a preemptive and voluntary recall of powder formulas from its various brands. The recall was issued after four consumer complaints related to Cronobacter sakazakii or Salmonella Newport.

Which Baby Formulas Have Been Recalled?

Some of the most popular brands of baby formulas have been recalled, including Similac, EleCare and Alimentum. ByHeart formula has also been recalled. The recalls are not connected to reports of necrotizing enterocolitis in premature babies who were fed cow’s milk-based baby formulas.

With headlines about recalls, the persistent infant formula shortage and cases of formula causing illnesses, there has been some confusion about which brands were recalled and why. Both the Abbott baby formula recall and the ByHeart recall were related to contamination at production facilities where Cronobacter sakazakii or Salmonella Newport were detected.

These cases of NEC, a severe gastrointestinal condition that primarily affects premature infants and those who are medically fragile, have led to lawsuits against manufacturers Abbott Laboratories and Mead Johnson. Parents have launched these lawsuits against baby formula manufacturers, claiming the companies failed to warn parents and medical providers about the risk of NEC associated with their baby formulas.

Abbott

The largest Abbott brands involved in the Feb. 17, 2022, recall included Similac and Alimentum, manufactured in Abbott’s Sturgis, Michigan, facilities. The recall only affected specific lots of the products.

The following products are included in the recall if they have all three items below:
  • First two digits of the code are 22 through 37, and
  • Code on the container contains K8, SH or Z2, and
  • Expiration date is 4-1-2022 (APR 2022) or later

As the CDC advises, review the codes on the bottom of your formula package to see if it’s included in the recall. You can also check online at the manufacturer’s website to confirm recalled products. Abbott offers a product lookup on its site to help consumers.

Recalled Abbott formulas:

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 CDC strongly advises against feeding babies any of the recalled powdered formula. Recalled products can be returned to the store for a refund or exchange. Abbott also has a hotline you can call for more information about the recall – 1-800-986-8540.

Enfamil

Enfamil formulas were not part of any recall. All Enfamil, Nutramigen and PurAmino branded products continue to be safe to use. Reckitt-Mead Johnson manufactures Enfamil products and is not connected to the companies involved in recalls.

Mead Johnson products are, however, named in some lawsuits related to NEC. Speak with your child’s pediatrician if you have questions or concerns about the safety of any formula product.

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How Do I Know If My Baby Formula Is Recalled?

In order to tell if your powdered infant formula has been recalled, the FDA recommends looking at the lot code, a multidigit number on the formula container.

Do not use the formula if:
  • First two digits of the code are 22 through 37, and
  • Code on the container contains K8, SH or Z2, and
  • Expiration date is 4-1-2022 (APR 2022) or later

In addition to the products listed above, Abbott has recalled Similac PM 60/40 with lot codes of 27032K80 (can) and 27032K800 (case).

What Should Parents Do if Their Baby Formula Is Recalled?

If the baby formula you use has been recalled, speak with your child’s pediatrician. They may have sourcing information and can recommend the best substitutions for your baby’s needs.

Don’t buy imported formula online because it is not approved by the U.S. Food and Drug Administration. It’s also very important that parents don’t try to make their own formula or dilute the formula they have with water as this can lead to serious health hazards. Toddler formula should not be used if your baby is under 1 year of age.

If your baby is 12 to 15 months old, talk to your pediatrician about transitioning them to milk or a dairy alternative with sufficient calcium. Some alternative options include soy, oat and rice milk. Discuss any of your child’s specific food intolerance and nutritional needs with their pediatrician.

Please seek the advice of a qualified professional before making decisions about your health or finances.
Last Modified: July 26, 2023

6 Cited Research Articles

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  1. FDA. (2022, December 5). Powdered Infant Formula Recall: What to Know. Retrieved from https://www.fda.gov/consumers/powdered-infant-formula-recall-what-know
  2. Simon, S. (2022, October 21). Baby Formula Lawsuit Update January 2023. Retrieved from https://www.forbes.com/advisor/legal/product-liability/baby-formula-lawsuit/
  3. Reckitt-Mead Johnson. (2022, October 17). Reckitt-Mead Johnson formulas were not impacted by the recall and are safe to consume. Retrieved from https://www.hcp.meadjohnson.com/s/hcpm-subpage/a4b4J000000JJfyQAG/enfamil-formula-safety
  4. FDA. (2022, October 1). FDA Investigation of Cronobacter Infections: Powdered Infant Formula (February 2022). Retrieved from https://www.fda.gov/food/outbreaks-foodborne-illness/fda-investigation-cronobacter-infections-powdered-infant-formula-february-2022
  5. Ramierez, L. (2022, May 19). Where to buy baby formula – these retailers have stock. Retrieved from https://www.tomsguide.com/deals/where-to-buy-baby-formula
  6. Medaris, A. (2022, May 18). An ER doctor says he’s treating infants at risk for life-threatening seizures after they consumed diluted baby formula and urges parents not to take a risk with homemade versions. Retrieved from https://www.insider.com/er-doc-says-watered-down-homemade-formulas-putting-infants-danger-2022-5