Federal and state health officials are investigating 13 cases in 10 states of infant botulism linked to baby formula that was being recalled, authorities said Saturday.
ByHeart Inc. agreed to begin recalling two lots of the company's Whole Nutrition Infant Formula, the Food and Drug Administration said in a statement.
All 13 infants were hospitalized after consuming formula from two lots: 206VABP/251261P2 and 206VABP/251131P2.
The cases occurred in Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas and Washington.
No deaths were reported. The FDA said it was investigating how the contamination happened and whether it affected any other products.
Available online and through major retailers, the product accounted for an estimated 1% of national formula sales, according to the Centers for Disease Control and Prevention.
People who bought the recalled formula should record the lot number if possible before throwing it out or returning it to where it was purchased, the CDC said in a statement.
They should use a dishwasher or hot, soapy water to clean items and surfaces that touched the formula. And they should seek medical care right away if an infant has consumed recalled formula and then had poor feeding, loss of head control, difficulty swallowing or decreased facial expression.
Infant botulism is caused by a bacterium that produces toxins in the large intestine.
Symptoms can take weeks to develop, so parents should keep vigilant, the CDC said.
A ByHeart spokesperson did not immediately respond to an email seeking comment Saturday.
More specific information:
Outbreak Investigation of Infant Botulism: Infant Formula (November 2025)
Do not use certain lots of ByHeart Whole Nutrition Infant Formula. FDA’s Investigation is ongoing.
Product:
Certain lots of ByHeart Whole Nutrition Infant Formula:
- Lot: 206VABP/251261P2 (“Use by 01 Dec 2026”)
- Lot: 206VABP/251131P2 (“Use by 01 Dec 2026”)
The lot code and “Use by” date are located on the bottom of the infant formula can.
ByHeart Whole Nutrition Infant Formula makes up an estimated less than 1% of all infant formula sold in the United States and this outbreak does not create shortage concerns of infant formula for parents and caregivers.
Symptoms of Infant botulism
Most infants with infant botulism will initially develop constipation, poor feeding, loss of head control, and difficulty swallowing, which can progress to difficulty breathing and respiratory arrest. Symptoms of infant botulism, which is diagnosed clinically, can take as long as several weeks to develop following formula ingestion.
Stores affected
ByHeart Whole Nutrition Infant Formula is available for sale online and at major retailers nationwide.
Status
Ongoing
Recommendation
- Parents and Caregivers should not use certain lots of ByHeart Whole Nutrition Infant Formula and should throw this product away immediately. If your child is experiencing symptoms (see below) after consuming ByHeart Whole Nutrition Infant Formula and you still have the formula in your home, please record the information on the bottom of the package before throwing it away.
- Botulism can be fatal, and you should take action right away. If your child has consumed ByHeart Whole Nutrition Infant Formula and is experiencing signs and symptoms of botulism such as poor feeding, loss of head control, difficulty swallowing, or decreased facial expression, seek immediate health care.
- If you are a Physician and suspect your infant patient has botulism, immediately call 510-231-7600 for case consultation. Consultation is available 24/7.