ByHeart, Inc., Infant Formula
Centralized before Judge Arun Subramanian in the Southern District of New York in April 2026, the ByHeart, Inc., Infant Formula litigation consolidates federal claims arising from a nationwide recall of ByHeart infant formula following contamination findings linked to reports of infant illness. With only 22 total actions filed as of the JPML's September 2026 report, this is one of the youngest active dockets in the federal MDL system, combining marketing and sales-practices allegations with a products-liability theory tied to the underlying contamination event.
At this earliest phase, the structural questions that will shape the litigation's path forward remain open: no case-management order, leadership structure, or master complaint framework has had time to mature, and the docket has not yet developed a general-causation or product-identification record tying specific formula lots to specific illnesses. Duration and eventual scale will depend heavily on how many additional claims are filed or transferred in as the recall's full scope becomes clearer and as affected families identify and pursue claims.
Infant-formula contamination litigation of this kind typically turns on a combination of regulatory-record evidence — recall notices, FDA or manufacturer contamination findings, and internal quality-control records — and individualized medical proof connecting a specific consumed lot to a specific infant's illness. How efficiently those two categories of proof come together will shape whether this docket can develop a coordinated resolution path or requires more individualized case-by-case litigation. Criterica Intelligence's platform tracks this kind of early-stage contamination-recall MDL formation across every active docket, providing a consistent structural read on a litigation's earliest development without projecting any causation finding for this or any individual claim.
The litigation consolidates claims arising from a nationwide recall of ByHeart infant formula following contamination findings linked to reports of infant illness.
Very early — centralized in April 2026 with only 22 total actions filed as of the JPML's September 2026 report, with no case-management order, bellwether process, or causation record yet established.
Regulatory-record evidence such as recall notices and contamination findings, combined with individualized medical proof connecting a specific consumed formula lot to a specific infant's illness.
How many additional claims are filed or transferred in as the recall's full scope becomes clearer and as affected families identify and pursue claims will be the key driver of the docket's eventual scale.
Statistics shown reflect historical or illustrative model outputs derived from real case data. They are not predictions or guarantees of any individual outcome. Litigation results depend on facts, jurisdiction, judge, and counsel, and vary case by case. Model accuracy is subject to selection effects and changing legal dynamics.