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
In Washington
Quick Facts
- Cases: 1
- Hospitalizations: 1
- Deaths: 0
- Status: Ongoing
- Recall: Yes
Recall
- ByHeart Whole Nutrition Infant Formula: with the following lot numbers have been recalled:
- Lot: 206VABP/251261P2 (“Use by 01 Dec 2026”)
- Lot: 206VABP/251131P2 (“Use by 01 Dec 2026”)
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
-
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).
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).