Nationwide Recall After Contamination Confirmed
ByHeart, a major infant formula manufacturer, has issued a complete nationwide recall of all its products following laboratory tests that confirmed contamination with bacteria linked to botulism. The company announced on Monday that testing of 36 samples from three different production lots revealed five positive results for Clostridium botulinum type A.
Based on these findings, the company stated it cannot rule out the risk that all ByHeart formula across every product lot may have been contaminated. This alarming discovery has triggered a significant public health response across the United States and Canada.
Growing Number of Infant Illnesses Reported
Federal and state health officials have connected the contaminated formula to a botulism outbreak that began in August. At least 31 infants across 15 states have fallen ill after consuming the recalled ByHeart formula.
Officials have also revealed that other babies who drank ByHeart formula were treated for botulism in earlier months, with cases dating as far back as November 2024. These earlier cases are not officially counted in the current outbreak tally but are believed to be connected.
The U.S. Food and Drug Administration (FDA) initially reported a case count of 23 on November 14, but the number has since risen. Health experts note that infant botulism is a rare but potentially deadly illness that occurs when babies ingest bacterial spores that germinate in the intestine and produce a toxin.
Critical Information for Parents and Caregivers
ByHeart initiated a full recall of all its Whole Nutrition Infant Formula products on November 11. This recall includes all unexpired lots of formula cans and single-serve "anywhere" sticks. Despite the recall, some product has remained on store shelves, according to the FDA and state officials.
Parents and caregivers are urged to immediately stop feeding ByHeart formula to babies and should monitor children for symptoms, which can take up to 30 days to appear. Key symptoms of infant botulism include:
- Constipation
- Difficulty sucking or feeding
- Drooping eyelids
- Flat facial expression
- Weakness in the arms, legs, and neck
This illness is a medical emergency and requires immediate treatment. The CDC has reported that at least 107 babies nationwide have been treated for botulism with an IV medication known as BabyBIG since August 1. In a typical year, fewer than 200 infants in the U.S. are treated for this illness.
Consumers who purchased ByHeart formula directly from the company's website on or after August 1 are eligible for a full refund under an expanded policy. To report an illness tied to the outbreak, individuals should contact an FDA consumer complaint coordinator or fill out an online MedWatch form.
