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.
Editor’s Note: The Rhode Island Department of Health shared the following on Saturday.
Case of Infant Botulism Identified in Rhode Island
The Rhode Island Department of Health (RIDOH) is advising families and consumers that a case of infant botulism has been identified in Rhode Island. Babies get infant botulism if they eat something containing spores from the bacteria Clostridium botulinum.
After presenting with symptoms on October 24, this child was hospitalized. The child has since been discharged and is recovering. The infant botulism diagnosis was confirmed on November 7.
This child had consumed ByHeart Whole Nutrition Infant Formula, a milk-based powder formula with iron for children 0 to 12 months. This product was purchased online. RIDOH is supporting an investigation by the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) into a multi-state cluster of infant botulism cases where it was reported that several of the infants consumed ByHeart powdered infant formula.
Families should not use the following 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. Families who have this product with these lot codes at home should throw this product away immediately. (See label attached.)
ByHeart Whole Nutrition Infant Formula makes up an estimated less than 1% of all infant formula sold in the United States. This outbreak does not create shortage concerns of infant formula for parents and caregivers.
Infant botulism is a serious condition that can come on slowly and get gradually worse over time. If identified, it is very treatable with an antitoxin called botulism immune globulin. The sooner that treatment starts, the better. Most children recover fully from infant botulism.
Children younger than a year old should not be given honey, even if it is cooked. Infant botulism can be caused by the spores in honey.
Symptoms of infant botulism can include:
- Choking when trying to feed
- Constipation
- Weaker suck or poor feeding
- Eyelid drooping (ptosis)
- Lack of facial expressions, being unable to lift their head, or other signs of muscle weakness or paralysis
- Weaker crying
- Weakness or decreased muscle tone, especially starting at the top of their body and limbs, making your baby feel “floppy” and keeping them from reaching or grabbing
- Bowel movement changes, like not pooping for days or even weeks at a time
Additional information about infant botulism is available from the Centers for Disease Control and Prevention (CDC).
For more information related to this investigation please visit Infant Botulism Outbreak Linked to Infant Formula, November 2025 | Botulism | CDC and Outbreak Investigation of Infant Botulism: Infant Formula (November 2025) | FDA.