CDC Warns Against ByHeart Infant Formula Following Unprecedented Botulism Outbreak
The Centers for Disease Control and Prevention (CDC) has issued an urgent warning to parents and caregivers to immediately stop using any ByHeart Whole Nutrition infant formula. This alert follows a significant outbreak of infant botulism linked to the product, which has led to the hospitalization of dozens of infants across the United States.
As of December 10, 2025, the CDC reports that 51 infants from 19 states have been hospitalized and treated for botulism associated with this formula. While no deaths have been reported, health officials emphasize that this is an unprecedented event in the history of infant botulism.
Understanding the ByHeart Formula Outbreak
The investigation into ByHeart infant formula began on November 7, 2025, after the California Department of Public Health’s Infant Botulism Treatment and Prevention Program (IBTPP) notified the CDC of a concerning rise in cases. In response, the CDC and the U.S. Food and Drug Administration (FDA) immediately contacted ByHeart to remove the products from the market.
The response evolved rapidly as more data emerged:
- November 8, 2025: The CDC urged parents to stop using two specific lots of the formula.
- November 11, 2025: The warning was expanded to include all ByHeart infant formula products.
- December 10, 2025: The outbreak date range was expanded to include 10 cases dating back to December 2023.
Laboratory testing has confirmed that the formula was contaminated with botulism spores, which can cause severe illness in infants.
What is Infant Botulism?
Infant botulism occurs when a baby swallows spores of Clostridium botulinum. Once inside the baby’s gut, these spores grow and produce a toxin that attacks the nervous system, leading to muscle weakness and potential respiratory failure.
According to Dr. Jennifer Cope, chief of the Enteric Diseases Epidemiology Branch, this type of outbreak is extremely rare. “While we typically expect to see 150-180 individual cases of infant botulism annually, an outbreak of infant botulism is unprecedented,” Dr. Cope stated.
Recognizing the Symptoms
Parents should be vigilant for signs of infant botulism, which can develop over time. Common indicators include:
- Constipation: This is often the first sign of the illness.
- Feeding Difficulties: A noticeable struggle with sucking and swallowing.
- Altered Cry: A cry that sounds weak or different than usual.
- Loss of Muscle Tone: A lack of head control (often described as a “floppy” baby).
Treatment and Medical Response
Early detection is critical for a full recovery. All 51 infants identified in this outbreak were treated with BabyBIG®, a specialized treatment for infant botulism.
If you suspect your infant has consumed ByHeart formula and is exhibiting any of the symptoms mentioned above, seek immediate medical attention. Do not wait for symptoms to progress before contacting a healthcare provider.
Key Takeaways for Parents
- Immediate Action: Stop using any ByHeart Whole Nutrition infant formula immediately, even if it is found for sale online or in stores.
- Scope: 51 infants across 19 states have been affected.
- Warning Signs: Watch for constipation, weak crying, and difficulty feeding.
- Verification: Laboratory tests have confirmed the presence of botulism spores in the formula.
Frequently Asked Questions
Why is this outbreak considered “unprecedented”?
While individual cases of infant botulism occur every year, it is highly unusual for multiple cases to be linked to a single commercial product, making this specific outbreak a rare public health event.
What should I do if I still have ByHeart formula in my home?
Discard the product immediately. Ensure that your infant does not have access to it and consult your pediatrician if you have any concerns about your child’s health.
How is infant botulism treated?
Infants affected by this outbreak were treated with BabyBIG®, a targeted therapy designed to neutralize the botulinum toxin in infants.