Summary (tl;dr)

ByHeart has voluntarily recalled all batches of its Whole Nutrition Infant Formula nationwide due to an ongoing investigation into a multi-state outbreak of infant botulism linked to the product, which has hospitalized at least 15 babies.

Essential Background

Infant botulism is a rare but serious illness affecting babies under one year old, caused by ingesting Clostridium botulinum spores that produce toxins in their immature digestive systems. Symptoms can include constipation, poor feeding, a weak cry, muscle weakness, and breathing difficulties, requiring immediate medical attention. The bacteria are common in soil and dust, but contamination of infant formula is extremely uncommon.

The Full Story

ByHeart initially recalled two batches of its Whole Nutrition Infant Formula on November 7, 2025, after the U.S. Food and Drug Administration (FDA) notified them of a broader investigation into infant botulism cases. This recall was expanded to include all batches of ByHeart Whole Nutrition Infant Formula cans and Anywhere Pack™ nationwide on November 11, 2025. At least 15 infants in 12 states have been hospitalized with suspected or confirmed infant botulism since August 2025, all of whom had consumed ByHeart formula. While ByHeart, the FDA, and the CDC have not found Clostridium botulinum spores or toxins in any unopened ByHeart product, preliminary tests by California health officials on one opened can of ByHeart formula fed to a sick infant "suggest the presence of the bacteria that produce botulinum toxin." The FDA noted that ByHeart formula, despite making up less than 1% of U.S. infant formula sales, is "disproportionately represented among sick infants in this outbreak."

Why It Matters

This recall is significant because infant botulism can be life-threatening, and formula safety is paramount for vulnerable infants. Parents and caregivers are urged to immediately stop using and dispose of any ByHeart infant formula and to seek prompt medical attention if their baby has consumed the formula and develops symptoms. The ongoing investigation by the FDA aims to determine the source of contamination, ensuring the safety of infant nutrition products. This event also highlights broader concerns as ByHeart had a previous recall in December 2022 and received an FDA warning in August 2023 regarding contamination risks with a different bacterium (Cronobacter sakazakii), though no illnesses were reported in that instance.