ByHeart Formula Recall Lawsuit Seeks Class Action Status Over Clostridium Botulinum Contamination

Consumers were misled into buying the recalled ByHeart formula by claims that it was safe and only used “certified clean ingredients,” mothers argue.

A group of mothers from across the country have filed a class action lawsuit against the makers of ByHeart formula, which was recalled after being linked to an infant botulism outbreak.

The complaint (PDF) was brought by four women, including Kaileigh Rachwal of Massachusetts, Amber Stuart and Samantha De Oliveria of New York, and Kristina Torres of California, in the U.S. District Court for the Southern District of New York on December 2. 

The women say that while their children did not become sick, they and other mothers nationwide should be reimbursed by ByHeart Inc. for paying a premium for a product that put their children at risk.

ByHeart Infant Botulism Outbreak

Federal and state health regulators began to track an outbreak of infant botulism cases in early November, which at that time included 15 cases across 12 states.

On November 8, the U.S. Food and Drug Administration (FDA) and the U.S. Centers for Disease Control and Prevention (CDC) announced a ByHeart formula recall after conducting an investigation into the illnesses. Although the initial action only included two batches of the formula, an expanded recall was announced three days later, pulling all batches of ByHeart Whole Nutrition Infant Formula Cans and Anywhere Packs from the U.S. market.

A recent update by the CDC indicates the ByHeart infant botulism outbreak has now sickened at least 51 infants in 19 states. Case reporting has been expanded to include a date range from the product’s release in March 2022 until December 2025. All infants involved have been hospitalized.

A number of ByHeart formula recall lawsuits have already been filed by parents whose children were sickened, seeking compensation for their injuries. The newest filing, however, is different from these prior claims because it seeks class action status on behalf of all consumers who purchased the recalled formula, regardless of whether their children became ill.

In the lawsuit, plaintiffs all say they purchased the recalled infant formula believing it to be safe and paying a premium. They note that the product’s labeling and ByHeart’s website claim the formula is made with “Certified Clean Ingredients.”

The mothers note it is hard to square that claim with a product linked to dozens of infant botulism illnesses. They allege the company deceived consumers with misrepresentations about the safety of the product, noting that no parent or caregiver would have paid for contaminated infant formula.

As a result of the ByHeart recall, the cans consumers purchased were worthless and they should be reimbursed, the lawsuit claims. While the manufacturer is offering some refunds, plaintiffs say they do not go far enough.

“Consumers relied on the label Representations and Omissions in purchasing the Product. Consumers lack the meaningful ability to test or independently ascertain or verify a product’s label representations, especially at the point of sale, and discovering that the Products are at risk of containing contaminants such as C. botulinum.”

– Kaileigh Rachwal et al. v. ByHeart Inc.

The ByHeart formula recall lawsuit seeks class action status for anyone who purchased ByHeart infant formula over the last five years. The company is only offering refunds for purchases made after October 1, 2025.

The plaintiffs present claims of violations of New York, Connecticut, Massachusetts and California consumer protection laws and unjust enrichment.

ByHeart Formula Recall Lawsuits

While this is a class action claim, several other ByHeart formula recall lawsuits have been filed by parents who allege their children suffered injuries that were potentially life-threatening.

FDA inspectors have reported issues with the company’s manufacturing processes for years, including significant problems at its Reading, Pennsylvania facility in the summer of 2022, when cronobacter sakazakii was discovered in the processing area of the plant. Several weeks later, the same contaminants were found in a can of finished formula, yet the report indicates the company claimed that the laboratory made a mistake and that there was no contamination.

Investigators also discovered mold in sources of clean water, dead insect corpses in food production areas and roof leaks. These factors led to a ByHeart cronobacter recall in December 2022.

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