Why is ByHeart issuing a voluntary recall?Updated 3 hours ago

In response to a broader FDA investigation of infant botulism in babies across the U.S, and out of an abundance of caution, we have decided to initiate a voluntary recall of two batches of ByHeart Whole Nutrition Infant Formula. 

ByHeart was notified by the FDA that an estimated 83 cases of infant botulism were reported nationwide since August 2025. Of these, 13 babies had received ByHeart formula at some point. 

However, the FDA has found no direct link to infant formula in its investigation and no testing conducted by ByHeart or the FDA has confirmed the presence of Clostridium botulinum spores or toxins related to infant botulism in any ByHeart product. Importantly, infant formula has never been known to cause infant botulism.