ByHeart infant formula class action filed over botulism risk

ByHeart infant formula class action overview:

• Who: Plaintiff Monica Valenzuela filed a class action lawsuit against ByHeart Inc.
• Why: Valenzuela alleges ByHeart failed to disclose that its infant formula products were contaminated with Clostridium botulinum.
• Where: The ByHeart infant formula class action lawsuit was filed in New York federal court.

A new class action lawsuit accuses ByHeart of failing to disclose that its infant formula products were contaminated with Clostridium botulinum, which can cause infant botulism.

Plaintiff Monica Valenzuela’s class action lawsuit claims ByHeart misled consumers by failing to disclose on its packaging that its infant formula products were contaminated with the bacteria.

Valenzuela argues the contamination could lead to serious and life-threatening health consequences, including infant botulism, a rare but potentially fatal illness.

“Infant botulism is a rare but potentially fatal illness that poses a serious threat to the health of infants,” the ByHeart class action lawsuit says.

Valenzuela wants to represent a nationwide class of consumers who purchased ByHeart infant formula during the applicable statute of limitations period. She claims ByHeart is guilty of violating New York General Business Law and of negligence and unjust enrichment.

ByHeart recalled all infant formula products

Valenzuela argues ByHeart issued a recall of its infant formula products on Nov. 8, before expanding the recall to include all of its formula nationwide, including cans and single-serve sticks, on Nov. 11.

ByHeart said it decided to broaden the recall after learning the U.S. Food and Drug Administration found two more cases of infant botulism in babies who had consumed its infant formula, according to the ByHeart class action lawsuit.

Valenzuela claims ByHeart’s recall was insufficient, arguing it was designed to reach very few people and that a class action remedy is superior in every conceivable fashion.

“Defendant’s recall is designed to reach very few people and is designed to benefit very few of the consumers who purchased the products,” the ByHeart class action lawsuit says.

Valenzuela demands a jury trial and requests declaratory and injunctive relief and an award of monetary, statutory, compensatory, treble and punitive damages for herself and all class members.

Meanwhile, hundreds of lawsuits have been launched against the manufacturers of Enfamil and Similac, claiming the companies failed to warn that their cow’s milk–based formulas could endanger premature infants. 

Parents whose babies developed necrotizing enterocolitis or another gastrointestinal condition after using these products may qualify to participate in the ongoing multidistrict litigation.

Have you ever purchased ByHeart infant formula? Let us know in the comments.

Valenzuela is represented by Michael R. Reese of Reese LLP and Kevin Laukaitis and Daniel Tomascik of Laukaitis Law LLC.

The ByHeart infant formula class action lawsuit is Valenzuela v. ByHeart Inc., Case No. 1:25-cv-06333, in the U.S. District Court for the Eastern District of New York.

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