ByHeart Sued After Baby Formula Botulism Concerns Spark Nationwide Recall

Parents across the country are raising alarm after ByHeart Inc. expanded its baby formula recall amid concerns of Clostridium botulinum contamination, a rare but potentially life-threatening bacteria that can cause infant botulism. According to a newly filed lawsuit reported by Law360, a proposed class of consumers alleges that ByHeart failed to properly warn families and that the company’s recall response has been insufficient.

The class action, which was iled in New York federal court on November 14, 2025, is led by plaintiff Monica Valenzuela, who claims that ByHeart’s formula products are now “worthless” because of contamination risks. The lawsuit comes just days after the FDA announced an investigation into multiple infant botulism cases potentially linked to ByHeart’s formula.

Although ByHeart maintains that neither it nor the FDA has found botulism spores in unopened cans, the company still expanded its recall to include all formula products while cooperating with federal investigators. The lawsuit asserts violations of New York consumer protection laws, negligence, and unjust enrichment, alleging that families would not have purchased the product had they known about the potential contamination.

The Challenges of FDA Oversight

The ByHeart recall highlights a broader concern: the FDA continues to struggle to keep pace with the rising number of defective product cases and nationwide recalls, especially in the children’s nutrition and consumer-safety space. As supply chains expand and formula production becomes increasingly complex, identifying contamination or manufacturing failures in real time is becoming more difficult.

These oversight gaps can leave families vulnerable. When regulatory protections fall short, litigation often becomes the most effective method for holding companies accountable and improving product-safety standards.

If you believe you may have a claim or are in need of a personal injury attorney in New York, contact Napoli Shkolnik to schedule a free consultation with an experienced attorney who can explain your rights and help you pursue the compensation you deserve.