Outbreak Summary
OFT Law has been retained on behalf of infants and families affected by a severe multi-state outbreak of Infant Botulism linked to ByHeart Whole Nutrition Infant Formula. The U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) have confirmed an ongoing investigation and the manufacturer, ByHeart, Inc., has initiated a voluntary recall of the implicated lots. As of November 11, 2025, ByHeart has now recalled ALL lots of the product. Later testing confirmed the presence of the bacteria in unopened finished product, leaving no doubt that ByHeart is responsible for this horrible outbreak that has hospitalized at least 31 babies so far.
On November 12th, we sued ByHeart in federal court on behalf of the parents of an infant who became sick with Infant Botulism after consuming the ByHeart formula in Kentucky. On November 19th, we filed another lawsuit in federal court on behalf of a Minnesota family.
If your infant consumed ByHeart baby formula and has recently been hospitalized or shown signs of botulism, your family may be entitled to significant compensation. Please contact us using the form above to set up a time for a free consultation.
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More Details
The FDA announced an investigation into an outbreak of Infant Botulism following consumption of ByHeart powdered formula. This is a life-threatening, but rare, form of foodborne illness that attacks the body’s nerves and can lead to muscle weakness and breathing difficulties. At least 39 babies have been hospitalized with infant botulism after consuming ByHeart formula so far.
Botulism is a medical emergency. Parents and caregivers who used the recalled lots of ByHeart formula should watch for symptoms, which can take several weeks to develop.
Common Symptoms Include:
If your child shows any of these symptoms after consuming ByHeart formula, seek immediate medical attention.
Manufacturers of baby formula have a rigorous duty to ensure their products are free from dangerous contaminants like the C. botulinum spores. When an unsafe product causes serious harm, the company can be held liable for negligence, manufacturing defects, and failure to warn.
OFT Law is prepared to help your family pursue maximum compensation for the devastating impact of this outbreak, including:
If your infant was hospitalized due to botulism after consuming the recalled ByHeart formula, you have grounds for a baby formula lawsuit.
Contact OFT Law immediately at 866.477.2141 or fill out our online contact form for a confidential, no-cost case review. Protecting your child’s health is the first priority; pursuing justice is the next.