Infant formula being placed with a dispenser in a bottle.
(Photo Credit: Studio Neeby/Shutterstock)

ByHeart class action MDL overview:

  • Who: The Judicial Panel on Multidistrict Litigation consolidated 19 class action lawsuits filed against ByHeart.
  • Why: The class action lawsuits claim ByHeart’s infant formula was potentially contaminated with Clostridium botulinum, causing some infants to fall seriously ill.
  • Where: The complaints were consolidated in New York federal court.

The Judicial Panel on Multidistrict Litigation (JPML) has consolidated 19 class action lawsuits filed against ByHeart into a new multidistrict litigation (MDL) in New York federal court.

The complaints revolve around claims ByHeart’s infant formula was potentially contaminated with Clostridium botulinum. Nine plaintiffs argue their infant children became seriously ill with infant botulism, while the remaining 10 complaints assert economic injuries on behalf of purchasers.

The JPML found the lawsuits involve “common questions of fact” and that centralization in the Southern District of New York “will serve the convenience of the parties and witnesses and promote the just and efficient conduct” of the litigation, according to a transfer order filed April 2. 

The panel said centralization also will avoid duplicative fact and expert discovery as to these common issues, as well as the risk of inconsistent pretrial rulings, “particularly as to issues of expert admissibility and class certification.” 

The complaints share factual questions regarding the root cause of the alleged contamination, ByHeart’s manufacturing processes, and ByHeart’s compliance with applicable FDA and other regulations, the JPML said.

Centralization into MDL will avoid ‘duplicative fact,’ panel says

The ByHeart Infant Formula lawsuits were filed in 12 districts across the country, including Arizona, California, Illinois, Kentucky, Minnesota, New York, Pennsylvania, Texas, and Washington.

ByHeart announced a recall in November 2025, after the company discovered that some of its products may have been contaminated with Clostridium botulinum, according to the transfer order.  

In one of the class action lawsuits, a consumer argued ByHeart misled consumers by failing to disclose on its packaging that its infant formula products were contaminated with the bacteria.

Were you affected by the ByHeart infant formula recall? Let us know in the comments.

The ByHeart infant formula class action MDL is In re: ByHeart, Inc., Infant Formula Marketing, Sales Practices, and Products Liability Litigation, MDL No. 3178, in the U.S. District Court for the Southern District of New York.


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