ByHeart Infant Formula Recall Sparks Lawsuit Over Bacterial Contamination

Case Overview: The lawsuit alleges ByHeart distributed infant formula contaminated with Clostridium botulinum, forcing a nationwide recall and endangering infants.

Consumers Affected: Parents and caregivers who purchased ByHeart infant formula included in the November 2025 recall.

Court: U.S. District Court for the Central District of California

Parents who bought ByHeart infant formula are taking the company to court, claiming the product may have exposed their babies to a dangerous bacterium linked to a rare illness.

The lawsuit alleges ByHeart sold formula contaminated with Clostridium botulinum, the toxin-producing bacteria responsible for infant botulism.

Filed by Monica Valenzuela, the case accuses ByHeart of selling unsafe products while advertising them as clean, safe, and rigorously tested.

The complaint states that parents trusted the brand’s promises of quality, only to discover that the formula could carry a contamination risk with potentially life-threatening consequences.

According to the filing, Clostridium botulinum contamination can cause infant botulism, a rare but serious condition that weakens muscles and can lead to feeding issues, breathing problems, and paralysis in babies under one year old.

Recall Expanded Nationwide After FDA Linked Products to Infant Illness

The lawsuit centers on a recall ByHeart announced on November 8, which was expanded three days later to include all formula products nationwide. The affected items included both standard cans and single-serve sticks, sold online and through retailers across the United States.

ByHeart said it broadened the recall after the U.S. Food and Drug Administration reported two additional cases of infant botulism possibly tied to its products. The lawsuit claims the company acted too slowly and failed to notify enough consumers, leaving many unaware that their purchases could be contaminated.

Valenzuela says she learned of the recall only after news coverage appeared and argues that the company’s outreach was “designed to reach very few people.” She contends that a class-wide lawsuit is the only practical way to secure refunds, accountability, and long-term safety improvements.

Lawsuit Says Company’s “Clean and Safe” Marketing Misled Families

ByHeart launched in 2021 promising higher transparency and safety standards than major competitors. Its branding highlighted purity, traceability, and nutritional science as reasons parents could trust its formula. 

Valenzuela’s lawsuit claims those assurances were misleading, given that the company later recalled every product it had on the market.

“Parents purchased these products believing they were the safest choice available,” the complaint states. “Instead, they were sold infant formula contaminated with Clostridium botulinum.”

She argues ByHeart’s advertising and labeling misled families into paying premium prices for a product that failed to meet the company’s own claims about safety and quality.

Infant Nutrition Industry Faces Growing Legal and Safety Challenges

While the ByHeart filing takes aim at a different hazard—contamination rather than formulation—it joins other lawsuits that raise questions about safety oversight in the infant nutrition industry.

Hundreds of parents have sued the makers of Enfamil and Similac, alleging those cow’s milk–based formulas increased the risk of necrotizing enterocolitis in premature babies.

These NEC baby food cases, which have been consolidated in multidistrict litigation, claim the companies failed to warn consumers and hospitals about potential dangers associated with their products. 

In the ByHeart infant formula class action lawsuit, Valenzuela contends the company benefited financially from misleading marketing while endangering public health.

She seeks to represent a nationwide class of parents and caregivers who purchased ByHeart formula within the applicable limitations period.

The filing also requests that ByHeart issue a comprehensive recall notice and refund program for all affected consumers, arguing that the company’s earlier recall effort was insufficient.

Case Details

• Lawsuit: Valenzuela v. ByHeart Inc.
• Case Number: 1:25-cv-06333
• Court: U.S. District Court for the Eastern District of New York

Plaintiffs' Attorney

• Michael R. Reese (Reese LLP)
• Kevin Laukaitis and Daniel Tomascik (Laukaitis Law LLC)

Did you purchase ByHeart formula before the recall? Share your thoughts about the lawsuit in the comments below.