The Connecticut Department of Public Health (DPH) is alerting parents and caregivers that on November 11, 2025, ByHeart Inc. expanded its recall to include ALL ByHeart Whole Nutrition infant formula products. Parents and caregivers are advised to immediately discontinue using any ByHeart Whole Nutrition infant formula (including all lot numbers and sizes of cans and single-serve packets) and follow the FDA's instructions for safe disposal or replacement.
ByHeart Whole Nutrition Infant Formula was available for sale online and at major retailers nationwide. The FDA is continuing to work with the firm to ensure all potentially impacted products have been removed from the market.
To date, 15 infant botulism illnesses have been reported from 12 states. No cases linked to this outbreak have been reported in Connecticut to date; however, the DPH is monitoring the situation and alerting hospitals and healthcare providers statewide. Healthcare providers who suspect infant botulism should call DPH immediately at (860) 509-7994.
"Infant botulism is a medical emergency. Most babies fully recover with prompt treatment, though hospitalization is typically required," said Commissioner Manisha Juthani, M.D. "Babies' digestive systems are still developing and lack the protective intestinal bacteria that largely prevent issues in older children and adults. After age one, the risk drops significantly. During this recall, prompt recognition and medical care are essential to protect the youngest ones in our community."
Infant botulism occurs when spores from a type of bacteria called Clostridium botulinum are swallowed, infect a baby's large intestine, and start making a toxin. Symptoms often start with constipation and difficulty feeding (sucking and swallowing), a weak and altered cry, and loss of muscle tone. If untreated, infants with botulism experience progressive weakness that can lead to paralysis, breathing difficulties, and death. Botulism is treated with an antitoxin administered at the hospital. Parents and caregivers should seek medical care immediately if an infant shows signs of illness.