Items Tagged with 'botulism'

The Nara Organics infant botulism outbreak has ended, with four sick in three states. Whole genome sequencing (WGS) findings and a shared powdered milk supplier/processor indicate a common source of contamination with the 2025 outbreak linked to ByHeart infant formula.

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.

U.S. Senator Bill Cassidy, Chair of the HELP Committee, has written a letter to ByHeart Inc., the infant formula manufacturer linked to an ongoing botulism outbreak, demanding answers about the conditions that led to the sale of unsafe product.

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.

As of November 19, the number of infant botulism cases linked to consumption of ByHeart formula has grown to 31 across 15 states. ByHeart's testing of its own product has confirmed the presence of Clostridium botulinum.