Plaintiffs allege ByHeart's manufacturing facility failed to maintain adequate sanitation protocols, resulting in Cronobacter sakazakii contamination of powdered infant formula. Cronobacter causes life-threatening bloodstream infections and meningitis in neonates. FDA inspection reports documented deficiencies in environmental monitoring and pathogen testing procedures at ByHeart's manufacturing partner facilities.

Defendants

Entity	Role	Note
ByHeart Inc.	Manufacturer	Sole manufacturer of ByHeart Whole Nutrition infant formula
Reading Scientific Services Ltd.	Testing Laboratory	Third-party quality testing contractor for ByHeart products

Litigation Timeline

2023

ByHeart launches direct-to-consumer infant formula product

2024

First adverse event reports of infant illness linked to ByHeart formula

Early 2025

FDA inspection of ByHeart manufacturing partner — deficiencies noted

Mid 2025

Initial lawsuits filed in federal courts alleging contamination

Jan 2026

JPML motion filed to consolidate cases into MDL

Mar 26, 2026

JPML hearing scheduled in Birmingham, AL

Intelligence Signals

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Key Facts

Status: active

Geographic Exposure

·JPML consolidation pending (Birmingham hearing Mar 26, 2026)

·S.D.N.Y. (initial filings)

·E.D. Pa. (related filings)

·Nationwide — cases filed in multiple federal districts

Eligibility Criteria

✓Infant who consumed ByHeart Whole Nutrition formula
✓Diagnosed with Cronobacter sakazakii infection, sepsis, or meningitis
✓Illness occurred during or shortly after formula consumption
✓Formula from lot numbers identified in contamination reports

Sources

JPML Hearing Calendar FDA Infant Formula Recalls CDC Cronobacter Information