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.
