In a November 18 new release, The Maine Department of Health and Human Services' (DHHS) Maine Center for Disease Control and Prevention (Maine CDC) advises parents and caregivers not to use any ByHeart Whole Nutrition Infant Formula. According to the U.S. Food and Drug Administration (U.S. FDA), the company has voluntarily recalled their Whole Nutrition infant formula cans and Anywhere Packs amidst a link to a multistate outbreak of infant botulism.

The Maine CDC is urging Maine people to follow recall recommendations. 

"No one — infants, parents, or caregivers — should consume ByHeart Whole Nutrition infant formula while the U.S. FDA investigation is ongoing," said Maine CDC.

Infant botulism occurs when a baby swallows spores from a type of bacteria called Clostridium botulinum, which leads to the bacteria multiplying and producing toxins in the infant's large intestine. The earliest signs of illness may include:

• constipation,
• difficulty feeding (sucking and swallowing),
• a weak and/or altered cry,
• muscle weakness, which can progress to paralysis and difficulty breathing.

Parents and caregivers of babies who may have consumed ByHeart Whole Nutrition infant formula should watch for symptoms and seek medical care immediately if symptoms appear. Early intervention is important. Without treatment, infant botulism can lead to paralysis of the arms, legs, trunk, and muscles used for breathing and it can result in death. Wash items and surfaces that may have touched the formula using hot soapy water or a dishwasher.

The time from ingestion to symptom onset can be up to 30 days, so parents and caregivers should remain vigilant if they used ByHeart Whole Nutrition Infant Formula in recent weeks. Infant botulism can be treated with BabyBIG®, the only FDA-approved treatment for this illness. BabyBIG®, which is sourced through California's Department of Public Health, remains the standard first-line therapy for infant botulism and stops further progression of symptoms. With timely treatment, most infants fully recover over time.

The Maine CDC is currently investigating one suspected case of botulism in a Maine infant. The infant reportedly consumed ByHeart Whole Nutrition Infant Formula products in the weeks prior to their illness. The suspected case was reported on November 17; the child remains hospitalized. Treatment will include BabyBIG® while confirmatory testing is underway.

Infant botulism is rare in Maine. In 2022, Maine had its first confirmed infant botulism case reported in two decades.

According to the U.S. CDC, as of November 14, 2025, there were 23 confirmed or suspect cases of infant botulism across the United States associated with this outbreak. All cases have been hospitalized.