A proposed class of consumers has filed suit against ByHeart Inc., alleging the baby-formula maker concealed contamination with Clostridium botulinum—a bacterium capable of triggering rare but life-threatening infant botulism. The complaint, filed Thursday in New York federal court, claims the products are now “worthless,” and that the company’s recent recall—first announced last week and expanded Tuesday—falls dramatically short of protecting families.

Lead plaintiff Monica Valenzuela argues the recall excludes vast numbers of consumers and offers refunds only if parents retain products they’re understandably inclined to discard. The complaint portrays a recall system designed like a maze with no exit, leaving parents without compensation and without confidence.

FDA Investigation Intensifies as Recall Broadens

Agency Connects Botulism Cases to Formula Consumption

The lawsuit arrives days after the U.S. Food and Drug Administration announced an active investigation into cases of infant botulism tied to ByHeart’s formula. While ByHeart said it expanded its recall to include all formula products and is cooperating fully, the company maintains that neither it nor the FDA has discovered spores or toxins in unopened cans.

But Valenzuela contends the company’s own statements confirm that the FDA identified botulism cases among infants who ingested the formula. For parents who already tossed the cans out of fear, the recall’s refund conditions leave them stranded.

The suit also claims that many customers never kept receipts—especially those who bought products outside ByHeart’s online store—making refunds functionally unreachable.

Plaintiffs Say Warning Signs Were Ignored

FDA’s 2023 Letter Flags Allegedly Insufficient Safety Controls

According to the complaint, ByHeart knew or should have known its preventative procedures were inadequate. Valenzuela points to a 2023 FDA warning letter as evidence that the company had long been on notice that its safety practices needed reinforcement.

The suit alleges violations of New York General Business Law, negligence, and unjust enrichment, emphasizing that the proposed class seeks economic damages only, not personal-injury compensation.

Meanwhile, families of two infants diagnosed with botulism after consuming ByHeart products have already filed separate lawsuits in Arizona and Kentucky federal courts, further escalating legal pressure on the company.

Consumer Advocates Call Recall Insufficient

“This lawsuit is important to protect consumers from allegedly unsafe contaminated foods,” said Michael Reese of Reese LLP, counsel for Valenzuela. “The safety of our food system is crucial, and we look forward to protecting their interests.”

Representatives for ByHeart could not be reached Friday.

Valenzuela is represented by Michael Reese of Reese LLP, along with Kevin Laukaitis and Daniel Tomascik of Laukaitis Law LLC. Counsel for ByHeart has not yet appeared.