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.