11/12/2025
Updated Alert from the RI Department of Health:
All Lots of ByHeart Whole Nutrition Infant Formula Recalled Due to Multistate Infant Botulism Outbreak
The Rhode Island Department of Health (RIDOH) is advising healthcare professionals, consumers, and retailers that ByHeart Inc. has now recalled all ByHeart Whole Nutrition infant formula products due to a multistate infant botulism outbreak linked to the product. According to the Centers for Disease Control and Prevention (CDC), parents and caregivers in 12 states have reported feeding infants in this outbreak different lots of ByHeart infant formula that were not included in the company’s initial recall on November 8.
On November 9, RIDOH announced that a case of infant botulism had been identified in Rhode Island and that two lots of the product had been recalled. Parents and caregivers have reported feeding infants involved in this outbreak different lots of ByHeart infant formula that were not included in the company's recall. On November 11, ByHeart Inc. recalled all ByHeart Whole Nutrition infant formula products.
Parents and caregivers are urged to stop using any ByHeart Whole Nutrition infant formula immediately. This includes:
• All lot numbers
• All sizes of cans and single serve sticks
o If possible, record the lot number and best by date.
o If you have leftover ByHeart powdered formula that your infant was fed, keep it stored for at least a month. If your infant develops symptoms of infant botulism, your state health department may want to collect it for testing. If no symptoms appear after a month, throw the leftover formula away.
• Wash items and surfaces that may have touched the formula using hot soapy water or a dishwasher.
• Seek immediate medical care if your infant has consumed ByHeart Whole Nutrition Infant Formula and has any of these symptoms:
o Poor feeding
o Loss of head control
o Difficulty swallowing
o Decreased facial expression
• Symptoms of infant botulism can take as long as several weeks to develop, so parents should remain vigilant if they used ByHeart Whole Nutrition infant formula.
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