ByHeart has extended its voluntary recall to cover all batches of its Whole Nutrition Infant Formula and Anywhere Pack across the United States. The decision follows an ongoing investigation by the US Food and Drug Administration (FDA) into a national rise in infant botulism cases.
Although no unopened ByHeart products have tested positive for Clostridium botulinum spores or toxins, the company is removing all affected stock from circulation while testing continues. Independent third-party laboratories have begun examining all formula batches, and the FDA and California Department of Public Health have been granted unrestricted access to ByHeart’s facilities and product samples.
The FDA and the Centers for Disease Control and Prevention (CDC) are analysing 84 reported infant botulism cases identified since August. ByHeart was notified of potential links on 7 November 2025 and began cooperating with the agencies immediately. The company has committed to publicly sharing all findings from both regulatory and independent testing once available.
Infant botulism, though rare, is a serious illness caused when bacterial spores produce toxins in a baby’s intestinal tract. The FDA’s investigation remains ongoing, with results expected to determine whether additional measures will be required across the wider infant formula market.