ByHeart Formula Infant Botulism Lawsuits Consolidated in New York

At least 19 families are currently pursuing infant botulism lawsuits against the makers of ByHeart formula, following a recall issued late last year due to contamination problems.

A panel of judges has determined that all federal ByHeart infant formula lawsuits should be consolidated before one judge in the U.S. District Court for the Southern District of New Jersey, for coordinated discovery and pretrial proceedings in the claims, which each raise similar allegations that the recalled formula is responsible for a nationwide outbreak of infant botulism last year.

The infant botulism outbreak was first detected in November 2025 and subsequently linked to 51 infant illnesses nationwide by the middle of January. The U.S. Food and Drug Administration (FDA) and the U.S. Centers for Disease Control and Prevention (CDC) tracked the illnesses back to contaminated ByHeart formula, ultimately resulting in a ByHeart infant formula recall on November 8, 2025. 

Initially limited to two batches, the ByHeart recall was expanded just days later, pulling all batches of ByHeart Whole Nutrition Infant Formula Cans and Anywhere Packs from the U.S. market.

This has sparked multiple individual and class action ByHeart infant formula recall lawsuits nationwide by parents and caregivers, each alleging that the company failed to properly manufacture the recalled formula in a way that made it safe for infants. 

Individual lawsuits have been filed by families whose children were injured during the outbreak, while separate class action claims argue that parents whose children did not become ill should be refunded for the formula, alleging they would not have purchased or used the product had they known it carried a risk of infant botulism.

In January, a group of plaintiffs filed a motion with the U.S. Judicial Panel on Multidistrict Litigation (JPML), requesting that all federal ByHeart formula lawsuits be consolidated in the Southern District of New York as a multidistrict litigation (MDL) under U.S. District Judge Denise L. Cote for coordinated discovery and pretrial proceedings.

In complex consumer product litigation, when large numbers of claims may be filed by users of the same product who suffered similar injuries or damages, it is common for the JPML to centralize cases. This is intended to reduce duplicative discovery on shared issues, avoid conflicting pretrial rulings, and promote efficiency for witnesses and parties involved in the litigation.

JPML Approves ByHeart Lawsuits MDL

The JPML agreed with the plaintiffs and approved the request in a transfer order (PDF) issued on April 2, several days after the panel heard oral arguments on centralization, during which ByHeart reportedly supported the motion. The panel also selected the Southern District of New York as the venue and appointed U.S. District Judge Arun S. Subramanian to oversee the litigation.

According to the order, ByHeart currently faces nine individual injury claims, as well as 10 class action lawsuits.

“The actions will share factual questions regarding the root cause of the alleged contamination, ByHeart’s manufacturing process, and ByHeart’s compliance with applicable FDA and other regulations.”

– U.S. Judicial Panel on Multidistrict Litigation

Now that the cases have been consolidated, it is expected that Judge Subramanian will instruct the parties to begin preparing a series of representative cases to serve as early test “bellwether” trials in the coming months and years. These trials will give the parties an opportunity to see how a jury responds to the strengths and weaknesses of arguments, evidence and testimony likely to be repeated throughout the litigation.

However, if the bellwether trials and pretrial proceedings end with the parties failing to negotiate a settlement or reach another resolution, each individual claim may be later remanded back to the U.S. District Court where it was originally filed for trial.

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