ByHeart Formula Recall: Infant Botulism Outbreak Sparks Lawsuits – What Are Your Rights?

ByHeart Formula Recall: Infant Botulism Outbreak Sparks Lawsuits – What Are Your Rights?

The recent recall of ByHeart infant formula due to a multistate outbreak of infant botulism has parents nationwide concerned and seeking answers. With 31 reported cases of infant botulism linked to ByHeart formula across 15 states as of November 19, 2025, families are understandably worried about the health and well-being of their children. This article explores the details of the ByHeart formula recall, the potential link to infant botulism, and what legal rights parents may have if their child has been affected.

What is Infant Botulism?

Infant botulism is a rare but serious illness that affects babies under one year old. It occurs when a baby ingests Clostridium botulinum spores, which are found in the environment, including soil and dust. These spores can colonize in the infant’s intestines and produce botulinum toxin, a potent neurotoxin. This toxin can lead to muscle weakness, paralysis, and potentially life-threatening complications.

Symptoms of Infant Botulism

Symptoms of infant botulism can appear anywhere from 3 to 30 days after consuming contaminated formula. Early signs can be subtle and easily mistaken for other common infant ailments. Key symptoms to watch for include:

  • Constipation
  • Poor feeding (weak suck, tiring easily)
  • Weakness and floppiness (loss of head control, “floppy” movements)
  • Weak or altered cry
  • Decreased facial expression
  • Difficulty swallowing, excessive drooling

As the illness progresses, more severe symptoms such as muscle paralysis and difficulty breathing can occur. If your infant exhibits any of these symptoms, seek immediate medical attention. Infant botulism is a notifiable disease, and all suspected cases must be reported to the state public health department.

Diagnosis and Treatment

Initial diagnosis of infant botulism is based on clinical symptoms. Consultation with the Infant Botulism Treatment and Prevention Program is available for suspected cases. If clinical consultation supports infant botulism, treatment should begin as soon as possible; do not wait for laboratory confirmation. Treatment typically involves BabyBIG, a human-derived botulism antitoxin. With early diagnosis and treatment, most infants recover fully, though hospitalization and supportive care, including mechanical ventilation, may be necessary for weeks.

The ByHeart Formula Recall: What Happened?

In early November 2025, ByHeart issued a voluntary recall of two batches of its Whole Nutrition Infant Formula following notification from the FDA regarding an investigation into a recent outbreak of infant botulism. On November 11, 2025, the recall was expanded to include all ByHeart Whole Nutrition Infant Formula products, regardless of lot number or packaging. The FDA and CDC, along with state and local partners, are investigating the multistate outbreak.

The recall was initiated due to concerns that the formula may be contaminated with Clostridium botulinum. While ByHeart initially stated that no unopened products tested positive for the bacteria, the company later confirmed that laboratory tests did find Clostridium botulinum in some samples.

What to Do If You Have Recalled ByHeart Formula

If you have purchased ByHeart Whole Nutrition Infant Formula, the FDA and ByHeart recommend the following steps:

  1. Stop using the formula immediately. This includes all can sizes and single-serve packets.
  2. Take a photo or record the lot number and “best by” date found on the bottom of the can or packet.
  3. Mark any leftover formula with “DO NOT USE” and store it in a safe place for at least 30 days. Your state health department may want to collect it for testing if your infant develops symptoms. If no symptoms appear after 30 days, discard the formula.
  4. Wash items and surfaces that may have come into contact with the formula using hot, soapy water or a dishwasher.
  5. Monitor your infant for symptoms of infant botulism for up to 30 days after the last feeding of ByHeart formula.
  6. Seek immediate medical care if your infant develops symptoms such as poor feeding, loss of head control, difficulty swallowing, or decreased facial expression.

Legal Rights and Options

The ByHeart formula recall has raised serious questions about product safety and manufacturer liability. If your child has been diagnosed with infant botulism after consuming ByHeart formula, you may have legal recourse.

Lawsuits Against ByHeart

Several lawsuits have already been filed against ByHeart, alleging that the company was negligent in selling a defective product. These lawsuits seek compensation for medical expenses, emotional distress, pain and suffering, and other damages.

Who Can File a Lawsuit?

Families whose infants:

  • Consumed ByHeart’s brand of organic baby formula
  • Were diagnosed with botulism
  • Suffered damages that included hospitalization or other medical expenses

What Damages Can Be Recovered?

A successful lawsuit may provide compensation for:

  • Medical bills (past and future)
  • Hospitalization costs
  • Rehabilitative care
  • Lost wages (if a parent had to take time off work to care for the child)
  • Pain and suffering
  • Emotional distress
  • Long-term care (if the child suffers permanent disabilities)

Types of Lawsuits

  • Negligence: This type of lawsuit alleges that ByHeart failed to exercise reasonable care in the manufacturing, testing, and marketing of its formula.
  • Product Liability: This type of lawsuit alleges that the ByHeart formula was defective and unreasonably dangerous, making ByHeart liable for injuries caused by the product.
  • Class Action Lawsuit: These lawsuits are filed by one or more plaintiffs on behalf of a larger group of people who have suffered similar harm. Several class action suits have been proposed against ByHeart. These suits often allege that ByHeart failed to disclose that its infant formula products were contaminated with Clostridium botulinum.

How to Take Legal Action

  1. Consult with an attorney: An experienced product liability attorney can evaluate your case, explain your legal rights, and help you determine the best course of action.
  2. Gather evidence: Collect all relevant documents, including medical records, receipts for ByHeart formula, and photos or videos of your child’s symptoms.
  3. File a lawsuit: Your attorney can help you file a lawsuit against ByHeart and navigate the legal process.

Protecting Your Rights

The ByHeart formula recall is a stark reminder of the importance of product safety and the potential consequences of corporate negligence. If your child has been affected by the ByHeart formula recall and diagnosed with infant botulism, it is crucial to understand your legal rights and options. Contacting an attorney experienced in product liability and infant botulism cases can provide you with the guidance and support you need to pursue justice and secure the compensation your family deserves.