Baby Formula Lawsuits 2026: NEC, Safety Concerns & What Parents Should Know

Understanding formula-related lawsuits, recalls, and how to keep your baby safe.

Current Status (2026)

NEC Lawsuits: Thousands of cases pending against Similac & Enfamil for premature infant formulas

2022 Recall: Similac, Alimentum, EleCare recall resolved; production resumed

Current Safety: All major formula brands meet FDA safety standards

Key takeaway: These lawsuits primarily involve premature babies in NICUs, not typical infant formula use

Understanding the NEC Formula Lawsuits

What is NEC?

Necrotizing Enterocolitis (NEC) is a serious intestinal disease that primarily affects premature babies. The intestinal tissue becomes inflamed and can die, leading to:

  • Severe infection
  • Need for emergency surgery
  • Long-term digestive problems
  • In severe cases, death

The Lawsuits

Parents of premature infants who developed NEC have filed lawsuits against Abbott (Similac) and Mead Johnson (Enfamil), claiming:

  • Cow's milk-based formulas increase NEC risk in premature babies
  • Manufacturers failed to warn about this risk
  • Hospitals should have used donor breast milk instead

Important Context

These lawsuits involve:

  • Premature babies (born before 37 weeks)
  • Very low birth weight infants (under 3.3 lbs)
  • Babies in NICUs receiving specialized formulas

These lawsuits do NOT involve:

  • Full-term, healthy babies
  • Standard infant formulas for home use
  • Typical formula feeding scenarios

The 2022 Formula Recall

What Happened

In February 2022, Abbott issued a voluntary recall of powdered formulas made at its Sturgis, Michigan facility:

  • Products: Similac, Alimentum, EleCare
  • Reason: Potential Cronobacter sakazakii contamination
  • Impact: Contributed to the 2022 formula shortage

Current Status (2026)

  • Sturgis facility reopened and passed FDA inspection
  • All recalled products removed from market
  • Enhanced safety protocols implemented
  • Formula supply has normalized

How to Check for Recalls

  1. Visit FDA Recalls page
  2. Sign up for formula manufacturer alerts
  3. Check the lot number on your formula can
  4. Follow FormulaCompare for updates

Is Baby Formula Safe?

The Short Answer: Yes

For healthy, full-term babies, commercial infant formula is:

  • FDA regulated with strict nutritional requirements
  • Extensively tested for safety and nutrition
  • A complete nutrition source when breast milk isn't available
  • Used safely by millions of babies every year

Formula Safety Record

Despite headlines, formula-related illness is rare:

  • Cronobacter infections: ~2-4 cases per year in the US
  • Most contamination issues are from improper preparation at home
  • Manufacturing issues are rare and quickly addressed

How to Keep Your Baby Safe

Formula Preparation Safety

  • Wash hands thoroughly before preparing formula
  • Use clean, sterilized bottles and nipples
  • Follow package instructions exactly
  • Use within 2 hours at room temperature or 24 hours refrigerated
  • Discard any formula baby doesn't finish within 1 hour

For Premature or High-Risk Babies

  • Discuss feeding options with your NICU team
  • Ask about donor breast milk availability
  • Use ready-to-feed formula (sterile) when possible
  • If using powder, prepare with water heated to 158°F (70°C)

Storage Best Practices

  • Store unopened formula in cool, dry place
  • Use opened powder within 1 month
  • Check expiration dates before use
  • Don't buy dented or damaged containers

Should You Be Worried?

If You Have a Full-Term, Healthy Baby

No. The NEC lawsuits and safety concerns primarily affect premature infants in medical settings. Standard infant formula from major brands is safe for typical use.

If You Have a Premature Baby

Discuss feeding options with your healthcare team. They can advise on:

  • Breast milk vs. formula for your specific situation
  • Donor milk programs
  • Which formulas are appropriate
  • NEC risk factors for your baby

Frequently Asked Questions

Am I eligible for the NEC lawsuit?

Eligibility typically requires:

  • Baby was born premature (before 37 weeks)
  • Baby was fed cow's milk formula in NICU
  • Baby developed NEC
  • Diagnosis was within statute of limitations

Consult a lawyer specializing in these cases for evaluation.

Is Similac safe to use?

Yes. Current Similac products on shelves are safe. The 2022 recall has been resolved, and all products meet FDA safety standards.

Is Enfamil safe to use?

Yes. Enfamil products are FDA-regulated and safe for typical infant use.

Should I switch to European formula?

European formulas (HiPP, Holle, Kendamil) have different regulations but aren't necessarily "safer." All formulas sold legally in the US must meet FDA standards.

Is organic formula safer?

Organic formulas avoid synthetic pesticides in ingredients but aren't inherently "safer" from a contamination standpoint. Choose organic based on ingredient preferences, not safety fears.

Timeline of Major Formula Events

YearEvent
2022Abbott Sturgis plant recall; formula shortage begins
2022NEC lawsuits consolidated in MDL court
2022Abbott Sturgis plant reopens
2023Formula supply normalizes
2024First NEC bellwether trials begin
2025-26Ongoing NEC litigation; enhanced FDA oversight

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