Articles Tagged with ''Clostridium botulinum''

New ByHeart-commissioned research suggests that sulfite-reducing clostridia (SRC) enumeration, the “gold-standard” test for C. botulinum in powdered infant formula, which was used by Nara Organics prior to the ongoing outbreak, is insufficient. Experts who spoke to Food Safety Magazine agree C. botulinum should be considered as a foreseeable hazard requiring specific preventive controls.

Three babies in three states have been sickened in the second infant botulism outbreak identified since late-2025. All patients were fed Nara Organics Whole Milk Infant Formula. A recall has been issued, and product testing is underway.

In carrot puree, a low-acid matrix, heat plus pressure achieved significant spore reductions, while cationic antimicrobials enhanced sporicidal effects and prevented regrowth. The hurdle approach offers a potential alternative to conventional thermal processing at severe temperatures, which can degrade food quality.

FDA did not identify deficiencies in ByHeart’s production facilities that could explain the outbreak, but a powdered milk ingredient did test positive for C. botulinum. ByHeart is developing an action plan based on data generated from the investigations.

Notable pathogen–food commodity pairings emerged, including Clostridium botulinum and Alaskan traditional fermented meats and fish. The analysis was conducted by FDA and CDC researchers. 

FDA has declared the outbreak over with 48 confirmed and probable cases of illness. A root-cause investigation is still ongoing. FDA has also announced new “Operation Stork Speed” infant formula resources for families.

Following the ByHeart botulism outbreak, FDA intends to begin testing infant formula products and ingredients for Clostridium botulinum to help determine whether contamination by the pathogen is a “foreseeable hazard that companies could test for.”

FDA has shared information about a contaminated ingredient—organic whole milk powder—in the multistate outbreak of infant botulism associated with ByHeart powdered infant formula.

At the 55^th Session of the Codex Committee on Food Hygiene (CCFH), prompted by the ongoing infant botulism outbreak linked to ByHeart formula in the U.S., CCFH decided to initiate work related to the control of Clostridium botulinum in powdered infant formula.

As of December 10, a total of 51 infants are included in the ByHeart formula botulism outbreak. With an expanded case definition, CDC has identified cases that occurred as early as December 2023.