ByHeart Botulism Cases Taper Off, While Lawsuits and Food Safety Concerns Continue to Build

Recall sparked class action and personal injury lawsuits by parents nationwide over contaminated ByHeart infant formula.

Although federal investigators report that no new botulism cases have been linked to the massive infant formula recall in recent weeks, signaling that the outbreak may be over, parents nationwide are continuing to file ByHeart lawsuits alleging the product was sold despite contamination risks and delayed recall action.

The investigation began earlier this fall, when the U.S. Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) launched a joint review after identifying dozens of infant botulism cases across multiple states. In early November, the FDA notified ByHeart that investigators were examining more than 80 suspected cases, including several involving infants who had consumed the company’s formula.

As part of that investigation, preliminary testing conducted by state health officials later detected Clostridium botulinum in at least one opened can of ByHeart formula that had been fed to an affected child. Days later, on November 8, ByHeart announced a voluntary recall initially limited to two production batches, before expanding the recall to include all lots of its infant formula products.

In a recent ByHeart botulism outbreak update, the CDC said reported illnesses linked to the investigation have slowed in recent weeks, though regulators emphasized that the investigation remains ongoing and that infant botulism, while rare, can be life-threatening. Federal officials cautioned that cases can be difficult to trace conclusively to a single source.

According to the CDC, infant botulism occurs when babies ingest spores of Clostridium botulinum, a bacterium that can grow in the intestines and produce toxins that interfere with nerve function. Symptoms may include constipation, poor feeding, weak crying, loss of head control, and, in severe cases, breathing difficulties requiring hospitalization.

ByHeart Recall Response

The ByHeart recall triggered widespread concern among parents and health care providers, particularly given the premium pricing and marketing of the formula as a carefully engineered alternative to traditional infant nutrition products.

Following the recall, major retailers, including national grocery chains and big-box stores, began pulling ByHeart formula from shelves. However, a subsequent FDA announcement indicates the response came too late in some cases, allowing potentially dangerous products to remain available even after regulators raised concerns about a possible link to infant botulism.

Those allegations have fueled broader questions about how quickly manufacturers and retailers must act when early warning signs emerge during food safety investigations, particularly when products are intended for infants.

ByHeart Formula Lawsuits

The recall has led to a growing number of ByHeart infant botulism lawsuits, including both class action and individual personal injury claims filed by parents who purchased the formula and, in some cases, fed it to their children.

According to one class action complaint (PDF), brought by Jillian Lugo and Allison Noonan in the U.S. District Court for the Southern District of New York on December 10, ByHeart deceptively marketed and sold infant formula that was contaminated with, or at risk of containing, Clostridium botulinum, without disclosing that concern to consumers. The lawsuit claims ByHeart omitted material safety information from its packaging and marketing, leading parents to believe the formula was safe for consumption.

The filing alleges that ByHeart knew or should have known of contamination risks associated with its manufacturing processes, yet failed to adequately warn consumers. Parents contend they paid a premium price for the formula based on representations that it promoted healthy infant development, only to later learn of the recall and associated botulism investigation.

The complaint points to a prior FDA warning letter issued to ByHeart in 2023, which cited violations of federal infant formula manufacturing requirements. Plaintiffs argue those regulatory findings underscore allegations that ByHeart failed to maintain adequate quality controls before distributing its products nationwide.

The lawsuit seeks class certification and raises claims for deceptive business practices, breach of warranty, negligence and unjust enrichment, alleging consumers suffered economic losses by purchasing formula that was unsafe or worth less than represented.

Infant Botulism Lawsuits

In addition to class action complaints, families whose infants consumed ByHeart powdered formula and later showed symptoms consistent with botulism may be eligible to pursue financial compensation.

Attorneys are evaluating claims involving infants who required hospitalization, antitoxin treatment or suffered lasting health effects potentially linked to contaminated formula. Ongoing investigations are focusing on:

• Emergency medical treatment related to suspected botulism
• Diagnoses of confirmed or suspected infant botulism
• Infants who required intensive care or breathing support
• Long-term neurological or developmental complications following illness

ByHeart infant botulism lawsuits are being handled on a contingency-fee basis, meaning families pay no upfront costs and no legal fees unless a recovery is obtained through settlement or trial.

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