Update November 12, 2025: On November 11, 2025, all infant formula products by ByHeart Whole Nutrition have been recalled by the company. You should stop using any ByHeart Whole Nutrition infant formula immediately. This includes:
- All lot numbers
- All sizes of cans and single-serve sticks
Background
The Centers for Disease Control and Prevention and the U.S. Food and Drug Administration are leading a national investigation into a cluster of cases of infant botulism with a history of ByHeart powdered infant formula use.
The formula is produced in 3 locations nationally, including Portland, Oregon.
On November 8, 2025, ByHeart Inc. recalled two lots of Whole Nutrition Infant Formula:
- Lot: 206VABP/251261P2 ("Use by 01 Dec 2026")
- Lot: 206VABP/251131P2 ("Use by 01 Dec 2026")
Both Oregon Health Authority and the Oregon Department of Agriculture are assisting federal agencies with the investigation.
Oregon has had one case of infant botulism with a history of exposure to this formula. The infant has fully recovered. To protect family privacy, no additional information regarding the infant will be released.
Infant botulism is caused by the ingestion of spores of the bacterium Clostridium botulinum. The bacterial infection produces a neurotoxin in the infant's intestines leading to constipation, profound weakness, difficulty feeding, and paralysis.
Infant botulism is a rare and serious condition which can be treated with botulism immune globulin (called BIG-IV or BabyBIG). BIG-IV should be administered as early as possible in the illness. Cases in children over the age of one can be treated with antitoxin also as soon as possible.
Recommendations
All providers in Oregon are required to immediately report any suspect infant botulism cases to public health.
Initial diagnosis of infant botulism is based on clinical symptoms.
Consult with the Infant Botulism Treatment and Prevention Program for suspected cases.
If you suspect your infant patient has botulism, immediately call 510-231-7600 for case consultation, available 24/7.
If clinical consultation supports infant botulism, consider immediate hospitalization if not already and begin treatment as soon as possible with BabyBIG. Do not wait for laboratory confirmation.
Encourage families not to use recalled infant formula:
- Throw it away or return it to where you bought it.
- Wash items and surfaces that may have touched the recalled formula using hot soapy water or a dishwasher.
The federal investigation is ongoing and additional information will be provided to the public as it becomes available.
Contacts
State and local public health departments may be reached 24 hours a day for consultation:
- Clackamas County Health Department: 503-655-8411
- Multnomah County Health Department: 503-988-3406
- Washington County Public Health: 503-846-3594
- Oregon Health Authority epidemiologist on-call: 971-673-1111
Thank you for your partnership,
Richard Bruno, MD, MPH | Multnomah County Health Officer
Teresa Everson, MD, MPH, CPH, Multnomah County Deputy Health Officer
Sarah Present, MD, MPH | Clackamas County Health Officer
Christina Baumann, MD, MPH | Washington County Health Officer