Abbott Baby Formula Settlement

Medically reviewed | Published: | Evidence level: 1A
Abbott has agreed to pay approximately $385 million to resolve allegations concerning infant formula manufacturing, with no determination of liability. The September 14 announcement brings renewed attention to manufacturing safeguards and prevention of Cronobacter infection, a rare but potentially life-threatening illness in infants.
📅 Published:
Reviewed by iMedic Medical Editorial Team
📄 Pediatric Health

Quick Facts

Settlement Amount
Approximately $385 million
Higher-Risk Age
Under 2 months
Once Feeding Starts
Use within 1 hour

What does Abbott's baby formula settlement resolve?

Quick answer: The agreement resolves civil allegations about manufacturing compliance and government-funded purchases, with no determination of liability.

On September 14, the U.S. Department of Justice announced that Abbott would pay approximately $385 million to settle allegations involving powdered infant formula and nutritional products manufactured in Sturgis, Michigan, and Casa Grande, Arizona. The claims concerned purchases funded through federal and state programs between 2018 and 2022. Prosecutors alleged that conditions including leaking roofs and damaged manufacturing equipment increased contamination risks. The department explicitly stated that the resolved claims remain allegations and that liability has not been determined. [Justice Department announcement](https://www.justice.gov/opa/pr/abbott-agrees-pay-over-384m-settle-allegations-related-contaminated-infant-formula).

Abbott said the agreement relates to its manufacturing and the 2022 powdered formula recall, emphasizing that the settlement establishes no finding of fault. It also said unopened products collected from affected infants' homes tested negative for Cronobacter. Separately, CDC's investigation found that bacteria from the two available infant samples were not closely genetically related to strains recovered from the Sturgis facility. Those findings limit conclusions about the source of the investigated infections; they do not establish that manufacturing safeguards were adequate. [Abbott statement](https://abbott.mediaroom.com/2026-09-14-Abbott-reaches-agreement-with-Department-of-Justice-to-resolve-claims-relating-to-2022-infant-formula-recall), [CDC investigation findings](https://www.cdc.gov/cronobacter/outbreaks/formula-2022/index.html).

Why is Cronobacter a concern in infant formula?

Quick answer: Cronobacter can survive in powdered formula and occasionally cause severe infections, particularly in very young or medically vulnerable infants.

Cronobacter bacteria occur naturally in the environment and can contaminate formula during manufacturing or after a container is opened. Powdered infant formula is not sterile. Contaminated surfaces, scoops, water or feeding equipment can introduce bacteria during preparation. Although infections are rare, affected infants can develop sepsis, a life-threatening response to infection, or meningitis, inflammation of the membranes surrounding the brain and spinal cord. [CDC explanation of Cronobacter](https://www.cdc.gov/cronobacter/about/index.html).

CDC identifies infants younger than 2 months, babies born prematurely and those with weakened immune systems as higher-risk groups. Warning signs include fever, poor feeding, unusual crying or markedly reduced energy; some infants develop seizures. A baby with these symptoms needs immediate medical assessment. These signs cannot identify Cronobacter specifically, and clinicians may need blood or spinal-fluid testing to establish the diagnosis. [CDC symptoms, risk groups and diagnosis](https://www.cdc.gov/cronobacter/about/index.html).

How can parents reduce infection risks when preparing formula?

Quick answer: Use an appropriate formula, follow preparation and storage instructions, and take additional precautions for infants at higher risk.

CDC recommends considering liquid ready-to-feed formula when possible, especially for higher-risk infants, because liquid formula is manufactured to be sterile. Handling still matters after opening. When powdered formula is needed for a higher-risk baby, CDC advises boiling water, waiting about five minutes, then mixing while the water remains very hot. Measure water and powder exactly as directed and cool the prepared bottle before feeding to prevent burns. Families using prescribed specialty formula should discuss preparation with their baby's clinical team. [CDC prevention advice](https://www.cdc.gov/cronobacter/prevention/index.html), [CDC formula preparation guidance](https://www.cdc.gov/infant-toddler-nutrition/formula-feeding/preparation-and-storage.html).

Wash hands and clean preparation surfaces and feeding equipment. Keep scoops and container lids clean and dry. Use prepared formula within two hours of preparation and within one hour after feeding begins, whichever deadline comes first. Discard leftovers from a used bottle. If a freshly prepared bottle will not be used promptly, refrigerate it immediately and use it within 24 hours. Always check expiration dates and recall notices. [CDC handling and storage recommendations](https://www.cdc.gov/cronobacter/prevention/index.html).

The settlement concerns earlier manufacturing and recall events; it does not itself announce a new product recall. Decisions about a container should follow the applicable recall notice and its product identifiers. If a usual formula becomes unavailable, contact the baby's healthcare provider for an appropriate alternative. Never stretch supplies by adding extra water or making homemade formula. [Abbott settlement statement](https://abbott.mediaroom.com/2026-09-14-Abbott-reaches-agreement-with-Department-of-Justice-to-resolve-claims-relating-to-2022-infant-formula-recall), [CDC advice for caregivers](https://www.cdc.gov/cronobacter/outbreaks/formula-2022/index.html).

Frequently Asked Questions

No. The Justice Department states that the settlement resolves allegations without a determination of liability. CDC also reported that the two available infant bacterial samples were not closely genetically related to strains recovered from the facility. [CDC investigation](https://www.cdc.gov/cronobacter/outbreaks/formula-2022/index.html).

No. Powdered formula can contain germs or become contaminated after opening. CDC recommends considering liquid ready-to-feed formula, especially for higher-risk babies. [CDC prevention guidance](https://www.cdc.gov/cronobacter/prevention/index.html).

CDC says most babies can receive powdered formula prepared according to the container instructions using safe water. It recommends extra precautions for babies younger than 2 months, born prematurely or with weakened immune systems. Follow applicable local guidance and your clinical team's advice. [CDC preparation guidance](https://www.cdc.gov/infant-toddler-nutrition/formula-feeding/preparation-and-storage.html).

Fever, poor feeding, unusual crying, very low energy or seizures in an infant warrant immediate medical assessment. These symptoms can signal serious infection and should not be assessed solely by checking a formula label. [CDC symptoms guidance](https://www.cdc.gov/cronobacter/about/index.html).

CDC's guidance from the investigation does not recommend routine Cronobacter testing for infants without symptoms of meningitis or sepsis, even after recalled formula exposure. Stop using recalled products and seek prompt assessment if symptoms develop. [CDC testing guidance](https://www.cdc.gov/cronobacter/outbreaks/formula-2022/index.html).

References

  1. U.S. Department of Justice. [Abbott Agrees to Pay Over $384M to Settle Allegations Related to Contaminated Infant Formula](https://www.justice.gov/opa/pr/abbott-agrees-pay-over-384m-settle-allegations-related-contaminated-infant-formula). September 14, 2026.
  2. Abbott. [Abbott reaches agreement with Department of Justice to resolve claims relating to 2022 infant formula recall](https://abbott.mediaroom.com/2026-09-14-Abbott-reaches-agreement-with-Department-of-Justice-to-resolve-claims-relating-to-2022-infant-formula-recall). September 14, 2026.
  3. Centers for Disease Control and Prevention. [Cronobacter Outbreak Linked to Powdered Infant Formula](https://www.cdc.gov/cronobacter/outbreaks/formula-2022/index.html). September 29, 2025.
  4. Centers for Disease Control and Prevention. [About Cronobacter Infection](https://www.cdc.gov/cronobacter/about/index.html). September 29, 2025.
  5. Centers for Disease Control and Prevention. [Preventing Cronobacter in Infants](https://www.cdc.gov/cronobacter/prevention/index.html). September 29, 2025.
  6. Centers for Disease Control and Prevention. [Infant Formula Preparation and Storage](https://www.cdc.gov/infant-toddler-nutrition/formula-feeding/preparation-and-storage.html). May 14, 2026.