Parents File Lawsuits After Baby Formula Recall Sickens Infants

On November 11, 2025, manufacturer ByHeart initiated a recall of its Whole Nutrition Infant Formula products due to an outbreak of botulism linked to certain batches of the formula. 

Previously, ByHeart had recalled specific lots of formula on November 7th. However, by the 11th of the month, it expanded the recall to all ByHeart Whole Nutrition Infant Formula products and Anywhere Pack products. 

The recall was in response to 15 infants in 12 states having fallen ill with suspected or confirmed botulism after consuming the formula.

ByHeart infant formula recall-related lawsuits

Following the recall of ByHeart formula, two families filed lawsuits against the company, alleging their babies had become ill from botulism resulting from consuming the product. 

Stephen and Yurany Dexter, of Arizona, filed a lawsuit on behalf of four-month-old Rose, who required air ambulance transport and extended hospital treatment. 

Separately, a Kentucky lawsuit was filed by Michael and Hanna Everett on behalf of four-month-old Piper, who was hospitalized on November 8th, 2025, with infant botulism after finishing a can of ByHeart formula the day before the recall. 

The lawsuits allege, among other things:

• The formula the babies consumed was a defective product. 
• The manufacturer was negligent in designing, manufacturing, testing, marketing, and/or distributing the formula. 
• The plaintiffs are entitled to seek compensation for medical bills, emotional distress, pain and suffering, loss of enjoyment of life, and other damages.

It seems likely that there will be additional lawsuits, as the number of affected infants continues to increase. At the time of this writing, there were 23 confirmed cases of infant botulism linked to ByHeart formula.

Legal questions and issues that will likely drive litigation strategy

Several product liability theories could inform how these lawsuits are resolved:

• Design or manufacturing defect. Plaintiffs may argue that the formula was unsafe, or contaminated with spores of Clostridium botulinum (or did not adequately prevent spore survival/growth), thereby being defective.
• Failure to warn. Plaintiffs may contend the manufacturer failed to provide adequate warnings or instructions concerning botulism risk, although infant botulism from formula is exceedingly rare.
• Strict liability or negligence. Some jurisdictions allow claims under strict liability (for defective products) or negligence (for failure to exercise reasonable care) depending on state law.

Proving causation

Essentially, the plaintiffs’ lawyers will need to prove that the babies ingested formula that (1) contained botulinum bacteria spores, and (2) this contamination caused the baby to become ill with botulism. 

However, the FDA has noted that a negative botulism test result in a can of formula does not necessarily mean there’s no contamination present. 

The manufacturer has argued that testing from a previously opened can lacks the scientific basis to establish causation. In other words, there are ways for the bacterium to enter the product once open; the manufacturer claims that if the can was not tested prior to the baby’s having finished the product, then it would be difficult to establish causation. The link is strong, but experts will examine factors like lot numbers, handling and storage of formula, other exposures, and the baseline risk for infant botulism. Ultimately, the court will make the final determination of liability.

Potential for multi-jurisdiction or class action lawsuits

Given the multi-state nature of the outbreak (12 states) and multiple affected infants, there might be consolidation of cases (i.e., multidistrict litigation) or coordinated class action lawsuits.

What to do if your baby is affected by the ByHeart recall

If your baby became ill with botulism after consuming ByHeart formula, follow these steps:

1. Of course, the first step is to seek medical treatment for your baby. Infant botulism is an extremely rare but potentially catastrophic illness in infants under one year. The affected babies faced muscle weakness, loss of head control, feeding/swallowing difficulty, and required intensive care.
2. Preserve samples of the formula, lot numbers, and receipts from purchase if you have them.
3. Secure medical records, including hospitalization, diagnosis of infant botulism, and the baby’s treatment regimen.
   
   Remember, the basis for personal injury law is that an injured plaintiff is entitled to be made financially whole, which means you’re restored to the financial condition you would be in if the accident or injury never happened. One of the critical elements for a personal injury claim is an actual injury—in other words, if your baby consumed botulism-contaminated formula but didn’t get sick, you do not have a lawsuit. You might feel frightened, angry, or upset, but if your baby wasn’t sickened and did not require medical treatment, you would be ineligible for a lawsuit in this case.
4. Consult an attorney to discuss securing expert medical testimony that would connect formula exposure to illness and defect, and to project future impairment. Ask your lawyer about joining or monitoring coordinated plaintiff-action efforts like a class action or multi-district litigation.
5. Stay apprised of recall and litigation developments, such as new lot identifications, additional cases, and regulatory findings.

Importantly: If you have questions, there is now an Infant Botulism Outbreak Hotline at 1-833-398-2022.

The outbreak of infant botulism linked to ByHeart infant formula and the ensuing nationwide recall have triggered early lawsuits that may represent the tip of what could become a much broader product-liability wave. The combination of hospitalized infants, formula exposure, and recall expansion, creates a compelling narrative for plaintiffs’ counsel and significant defense challenges for the manufacturer.