The Maine Center for Disease Control and Prevention (Maine CDC) has issued a strong advisory urging parents and caregivers across the state to immediately stop using ByHeart Whole Nutrition Infant Formula following a voluntary recall by the manufacturer due to possible contamination with Clostridium botulinum, the bacteria that causes infant botulism.
The recall was initiated after the product was linked to a multistate outbreak of infant botulism currently under investigation by the U.S. Food and Drug Administration (FDA). Both canned formula and “Anywhere Packs” are affected.
What is Infant Botulism?
Infant botulism occurs when an infant ingests spores of Clostridium botulinum. The spores can germinate in the baby’s intestines, multiply, and produce a dangerous toxin. Early symptoms may include:
- Constipation (often the first sign)
- Poor feeding or weak suck
- Weak or altered cry
- Drooping eyelids or lethargic appearance
- Muscle weakness that can progress to paralysis
- Difficulty breathing
Without prompt treatment, the condition can lead to paralysis of the arms, legs, trunk, and respiratory muscles—and in severe cases, death.
Symptoms may appear up to 30 days after exposure, so even parents who used the formula weeks ago should remain vigilant.
Treatment and PrognosisThe only FDA-approved treatment is BabyBIG® (Botulism Immune Globulin Intravenous), which neutralizes the toxin and halts progression of the disease. When administered early, most infants make a full recovery over weeks to months.Maine
The Maine CDC is investigating one suspected case of infant botulism in a Maine infant who consumed ByHeart Whole Nutrition Infant Formula in the weeks before becoming ill. The case was reported on Nov. 17, and the child remains hospitalized. Confirmatory testing is ongoing, and the infant is receiving BabyBIG®. This marks only the second known case of infant botulism in Maine in more than two decades. The first confirmed case in 20 years occurred in 2022.
As of Nov. 17, the U.S. CDC reports 23 confirmed or suspected cases of infant botulism linked to this outbreak nationwide. All affected infants have required hospitalization.
What Parents Should Do Right Now
- Do NOT use any ByHeart Whole Nutrition Infant Formula (cans or Anywhere Packs).
- Check your pantry, diaper bag, or anywhere formula is stored and discard or return affected products.
- Clean all bottles, nipples, pump parts, and surfaces that may have come into contact with the formula using hot, soapy water or a dishwasher.
- Watch your baby closely for any signs of illness—even if the formula was used weeks ago.
- Seek immediate medical care if any symptoms appear. Tell your healthcare provider about possible exposure to the recalled formula.
Parents who need help finding safe alternative formula should contact their pediatrician or local WIC office.
The Maine CDC emphasizes that early recognition and treatment are critical. While infant botulism is rare, the consequences can be severe, and quick action can be life-saving.
For the latest recall details and affected lot numbers, visit the FDA website.
The investigation is ongoing, and health officials continue to work with federal partners to protect Maine families.
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