Items Tagged with 'Clostridium botulinum'

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.

The nationwide infant botulism outbreak associated with ByHeart infant formula has grown to 39 cases in 18 states. All 39 infants were hospitalized; no deaths have been reported.

ByHeart Inc. tested its products and found C. botulinum Type A in five of 36 samples across three lots. As of November 26, the outbreak includes 37 cases of infant botulism spanning 17 states. FDA has published inspection documents for ByHeart production facilities confirming a history of food safety issues.

Although the official number of infant botulism cases included in the ByHeart infant formula outbreak remains at 31, the unusual spike in infant botulism treatments recorded by the California Department of Public Health has grown to more than 100, and several babies with exposure to ByHeart formula were treated for botulism as early as November 2024, months ahead of the spike in illnesses.