Families Seek To Consolidate ByHeart Lawsuits Over Infant Botulism Outbreak

Nationwide infant botulism outbreak linked to contaminated formula has resulted in 51 infants being sickened and hospitalized across 19 states, leading to a growing number of ByHeart lawsuits in the federal court system.

Families who are pursuing lawsuits against the makers of ByHeart formula, over a nationwide infant botulism outbreak caused by contaminated bottles recalled late last year, are asking a panel of federal judges to consolidate all cases before a single judge for coordinated pretrial proceedings.

The U.S. Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) issued a warning to the public about a multistate infant botulism outbreak in November 2025. A subsequent investigation led to the announcement of a ByHeart infant formula recall.

While the initial action only included two batches of the formula, an expanded recall was announced just days later, removing all batches of ByHeart Whole Nutrition Infant Formula Cans and Anywhere Packs from the U.S. market.

Infant Botulism Outbreak

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 to this rare but serious illness than adults. 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.

According to the CDC, 51 babies were sickened and hospitalized by the ByHeart infant botulism outbreak across 19 states. Health regulators believe the outbreak has ended, as no new cases have been identified since December 10, 2025.

However, in the wake of the illnesses and recalls, nearly 20 individual and class action ByHeart lawsuits have been filed by parents nationwide who say 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.

To avoid duplicative discovery and inconsistent rulings, plaintiffs filed a motion for transfer (PDF) with the U.S. Judicial Panel on Multidistrict Litigation (JPML) on January 15. The request cites overlapping legal issues and facts, seeking the creation of a ByHeart multidistrict litigation (MDL) under U.S. District Judge Denise L. Cote in the Southern District of New York to coordinate pretrial proceedings.

According to the motion, there were 18 Byheart lawsuits filed at the time of the motion, eight of which were brought in the Southern District of New York, where ByHeart is headquartered.

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.

The JPML is expected to consider oral arguments on the motion, including any response filed by the manufacturer, during a hearing in March 2026. The panel will then determine whether centralized management is appropriate at this stage, and the most appropriate forum for the pretrial proceedings.

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.

ByHeart Formula Concerns

Federal inspectors have documented repeated manufacturing deficiencies at ByHeart’s facilities years before the infant formula recall, including serious sanitation failures uncovered at the company’s Reading, Pennsylvania plant in the summer of 2022. During that inspection, Cronobacter sakazakii was detected in a processing area.

Weeks later, the same bacteria was found in a can of finished formula, though the inspection report indicates the company disputed the result, attributing it to laboratory error and maintaining that no contamination had occurred.

Inspectors also reported mold in sources of purified water, dead insects in production areas, and roof leaks above manufacturing spaces. The findings ultimately led to a nationwide ByHeart formula recall in December 2022.

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