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ByHeart Infant Formula Recalled Nationwide Over Botulism Fears, Massachusetts DPH Issues Urgent Warning

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Published on November 12, 2025
ByHeart Infant Formula Recalled Nationwide Over Botulism Fears, Massachusetts DPH Issues Urgent WarningSource: U.S. Food and Drug Administration

In an alarm-raising turn of events, ByHeart Inc. has issued a nationwide recall of its powdered Whole Nutrition Infant Formula amid fears of contamination with the bacteria Clostridium botulinum, a known cause of infant botulism, as per a recent announcement from the Massachusetts Department of Public Health (DPH). While there have been no cases reported in Massachusetts, parents and caregivers across the state are urgently cautioned to cease the use of ByHeart formula.

The recall follows a statement issued by the DPH yesterday, indicating a broader federal investigation into an outbreak that prompted the recall decision. Upon identifying a potential link to the formula, the FDA and the CDC have been actively investigating the matter since November 8. Nationwide, consumers in possession of the affected product are advised to discard it or return it to the place of purchase.

Parents should be vigilant for any symptoms of infant botulism, especially if their child has consumed the recalled formula. According to the Massachusetts DPH, signs of the illness include constipation, poor feeding, loss of head control, and difficulty swallowing, among others. They recommend immediate medical attention for infants showing any such symptoms. ByHeart products, the cause of this scare, are usually sold online and have a vast distribution network throughout the United States.

For those disposing of the affected formula, the DPH advises that they note or photograph lot numbers typically found on the bottom of the cans prior to disposal. In dealing with any objects that might have come into contact with the product, hot soapy water or a dishwasher is recommended for thorough cleaning. Families who have already transferred the formula to other containers are not spared from precaution and should check their storage for possible contamination.

Caregivers are advised to monitor infants for up to 30 days after the last exposure to the recalled formula for any symptoms. The DPH emphasizes the importance of not waiting for testing or seeking any treatment unless the infants exhibit symptoms of botulism. Concerned parties can contact the local health department, the Division of Food Protection at [email protected], or call (617) 983-6712 for inquiries.

The FDA, which states that ByHeart Whole Nutrition Infant Formula constitutes less than 1% of the nation's infant formula sales, has ruled out concerns of a shortage due to this incident. For the latest updates on this ongoing investigation, individuals are encouraged to visit the official CDC or FDA web pages dedicated to this outbreak.