• On February 26, 2026, the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) announced that the multistate outbreak of infant botulism (C. botulinum) has ended, with no new illnesses reported since December 2025.
  • As we previously reported, the outbreak was linked to ByHeart infant formula products.  The company initiated recalls after illnesses were linked to its formula between August 9 and November 11 and were reported in 13 states.  As of February 26, 2026, the investigation includes 28 cases of confirmed infant botulism and 20 cases of probable infant botulism.  All ByHeart infant formula products have been recalled.
  • Another infant formula recall lead to a global shortage in 2022, which ignited a larger discussion on infant formula market concentration (see FTC and NASEM reports). 
  • Keller and Heckman will continue to monitor developments regarding infant formula.