JPML To Consider ByHeart Formula Recall Lawsuit Consolidation in March 2026

Infant botulism lawsuits have been filed throughout the federal court system, after recalled ByHeart infant formula was linked to illnesses among at least 51 infants across 19 states.

A panel of federal judges will hear oral arguments next month on whether to consolidate and centralize nearly 20 ByHeart formula infant botulism lawsuits before one judge for coordinated pretrial proceedings, which could lead to early trial dates and settlement talks.

The litigation emerged after the U.S. Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) warned the public of a multistate infant botulism outbreak in November 2025, leading to a ByHeart infant formula recall.

While the warnings were initially limited to only two batches of the formula, the recall was later expanded to include all batches of ByHeart Whole Nutrition Infant Formula Cans and Anywhere Packs from the U.S. market, amid growing reports of infant botulism among babies exposed to the formula.

Infant botulism is caused by Clostridium botulinum, a bacterium that produces a neurotoxin capable of disrupting normal nerve and muscle function. Because infants have immature gut flora and underdeveloped immune systems, they are more vulnerable than adults to this rare but serious illness. This can lead to loss of muscle tone, energy levels, the ability to feed and respiratory strength, resulting in constipation, lethargy, breathing problems and paralysis.

The CDC reports that the ByHeart infant botulism outbreak sickened and hospitalized 51 infants in 19 states before apparently ending in early December 2025, after which no new cases have been reported.

In the wake of the recall and outbreak, parents and caretakers began filing individual and class action ByHeart formula recall lawsuits, alleging that their children were sickened after consuming the recalled infant formula, or that they should be refunded for being misled into buying a product that could have caused severe harm to their children.

Last month, a group of plaintiffs filed a motion asking the U.S. Judicial Panel on Multidistrict Litigation (JPML) to establish a ByHeart formula lawsuits MDL, or multidistrict litigation, calling for claims brought in federal courts nationwide to be consolidated before U.S. District Judge Denise L. Cote in the Southern District of New York for coordinated discovery and pretrial proceedings.

The motion indicated that at least 18 ByHeart formula recall lawsuits have been filed, with eight in the Southern District of New York. The plaintiffs say consolidation, which is common in complex consumer product litigation, would reduce duplicative discovery, avoid conflicting pretrial rulings and promote efficiency for witnesses, parties and the Court.

On February 13, the JPML issued a Notice of Hearing Session (PDF), scheduling oral arguments over the motion to be held on March 26, 2026, in the Hugo L. Black United States Courthouse in Birmingham, Alabama. Sometime after that hearing, the panel will determine whether the cases should be consolidated or should proceed forward as individual lawsuits.

Consolidation would mean that the cases remain individual lawsuits, with plaintiffs still responsible for showing that their children were injured by recalled ByHeart infant formula. However, the district judge assigned to the litigation would likely have the parties prepare for early test cases known as bellwether trials, which give the parties a chance to see how their arguments and evidence holds up before a jury.

While the outcomes of these trials are not binding on other claims, they are usually closely watched and could have a significant impact on settlement negotiations. If a ByHeart lawsuit MDL is established and the parties fail 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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