The Centers for Disease Control and Prevention (CDC), the U.S. Food and Drug Administration (FDA) and public health officials in several states are investigating a multistate outbreak of infant botulism linked to ByHeart powdered infant formula.
In Washington
Quick Facts
- Cases: 2 (1 Confirmed and 1 Suspected)
- Hospitalizations: 2
- Deaths: 0
- Status: Ongoing
- Recall: Yes
November 14, 2025
A Pierce County case was diagnosed with suspected infant botulism. The case is being treated at a local hospital. Testing will be performed by a Public Health Lab to confirm the diagnosis. Please see Tacoma-Pierce County Health Department Press Release for more information.
The number of infant botulism cases nationwide has increased to at least 23 individuals from 13 states. Please see CDC | Infant Botulism Outbreak Linked to Infant Formula, November 2025 for updates.
November 12, 2025
The number of infant botulism cases nationwide has increased to 15 and the number of states affected has increased to 12. A resident of Lewis County is currently the only case in Washington. Please see CDC | Infant Botulism Outbreak Linked to Infant Formula, November 2025 for updates.
The product recall has expanded to include all ByHeart Whole Nutrition Infant Formula cans and Anywhere Pack™ nationwide. Please see FDA | Outbreak Investigation of Infant Botulism: Infant Formula (November 2025) for updates.
About Infant Botulism
Infant botulism is a rare illness that usually occurs in babies through 6 months of age (it can occur in babies up to 1 year of age). On average, 4 cases of infant botulism are reported each year in Washington.
Infant botulism occurs when the baby ingests a bacteria called Clostridium botulinum which can make a toxin inside the digestive system. This toxin can cause the following symptoms:
- Constipation
- A weak or altered cry
- Trouble swallowing
- Weak muscles in the arms, legs, and neck
- Floppiness
- Difficulty holding the head up
- Breathing problems
These bacteria are naturally present in dust and soil and babies can inhale or ingest the bacteria when they play on carpets or floors. The bacteria can also be naturally present in honey. Infants under 1 year of age should never be fed honey.
To Prevent Infant Botulism
- A clear source is not identified for most cases of infant botulism.
- Do not feed infants under 1 year of age honey or foods that contain honey.
More Resources
California Department of Public Health Infant Botulism Treatment and Prevention Program:
Infant Botulism Treatment and Prevention Program
To report a suspected foodborne illness or file a complaint about unsafe food handling practices at an establishment in Washington, use the Foodborne Illness Notification System (FINS).
Updates
Updated guidance to consumers:
- Do not use any ByHeart Whole Nutrition infant formula. This includes formula sold in cans and single serve packets.
- If you currently have any ByHeart Whole Nutrition infant formula:
- If possible, take a picture or record the “use by” date and the lot number (all of the numbers, words and letters near the “use by” date--see product photos below)
- Put the formula into a container (such as a shopping bag or garbage bag)
- Label the outer container (bag): “DO NOT USE"
- Keep the formula stored in a safe place (such as a high cabinet) for at least a month.
- If your infant develops symptoms of infant botulism, your state health department may want to collect it for testing. If no symptoms appear after a month, throw the leftover formula away.
- If you are unable to safely store and label the leftover formula, please discard the product or return the product to the place of purchase.
- Wash items and surfaces that may have touched the formula using hot soapy water or a dishwasher.
- Seek immediate medical care if your infant has consumed ByHeart Whole Nutrition Infant Formula and has any of these symptoms:
- Poor feeding
- Loss of head control
- Difficulty swallowing
- Decreased facial expression
- Symptoms of infant botulism can take as long as several weeks to develop, so parents should remain vigilant if they used ByHeart Whole Nutrition infant formula.
November 10, 2025
The Centers for Disease Control and Prevention (CDC), the U.S. Food and Drug Administration (FDA) and public health officials in several states are investigating a multistate outbreak of infant botulism linked to ByHeart powdered infant formula.
The company has voluntarily recalled the formula while the investigation continues. The recalled formula was sold online and at major retailers nationwide.
A Lewis County infant recently diagnosed with infant botulism consumed ByHeart powdered infant formula prior to onset of symptoms.
This is an active investigation. For the most current updates, please see the CDC and FDA websites.
- CDC Food Safety Alert: Infant Botulism Outbreak Linked to Infant Formula, November 2025 | Infant Botulism | CDC
- FDA Outbreak Investigation: Outbreak Investigation of Infant Botulism ̶ Infant Formula | FDA
Recall
Advice to Consumers
- Do not use recalled infant formula. Throw it away or return it to where you bought it.
- If you still have the container, record the lot number before discarding.
- Wash items and surfaces that may have touched the recalled formula using hot soapy water or a dishwasher.
- Seek immediate medical care if your infant has consumed ByHeart Whole Nutrition Infant Formula and has any of these symptoms:
- Poor feeding
- Loss of head control
- Difficulty swallowing or change in voice
- Decreased facial expression
- Symptoms of infant botulism can take as long as several weeks to develop, so parents should remain vigilant if they used the recalled lots of infant formula.
Advice to Businesses
- Do not sell, use, or donate recalled infant formula.
- Wash and sanitize items and surfaces that may have touched recalled formula.
To report a suspected foodborne illness or file a complaint about unsafe food handling practices at an establishment in Washington, use the Foodborne Illness Notification System (FINS).