Federal Health Officials: ByHeart Formula Botulism Outbreak Officially Over

A dangerous botulism outbreak linked to ByHeart baby formula has officially ended after sickening 48 infants nationwide since 2023. All affected babies required hospitalization, though no deaths occurred, and no new cases have emerged since mid-December.

Federal health authorities announced Thursday that a dangerous botulism outbreak connected to ByHeart infant formula has officially concluded, with no additional cases documented since mid-December, according to the U.S. Centers for Disease Control and Prevention.

The outbreak affected a total of 48 infants beginning in 2023. Health officials noted this number represents a slight decrease from earlier reports after three children received different diagnoses unrelated to botulism.

Every affected infant required hospital care, though authorities report no fatalities occurred during the outbreak.

Health officials remain uncertain about the specific details of how, when, or where the organic whole-milk powder formula became infected with bacteria capable of causing severe illness, paralysis, and potentially death in infants under one year old.

The majority of cases emerged after August, when California’s Infant Botulism Treatment and Prevention program noticed a concerning increase in illness reports among babies who had consumed ByHeart products.

The New York-based company initially pulled two specific batches from shelves in early November, then broadened the recall to include all their products within days. Federal authorities later stated they couldn’t eliminate the possibility of contamination in products manufactured since the company began operations in March 2022. Retailers across the country removed the formula, which had been marketed as offering “next-to-breast milk benefits.”

Food and Drug Administration investigators have not yet determined the underlying cause of the contamination.

The agency released a statement explaining they had found 17 different bacterial strains in samples taken from patients, sealed formula containers, and raw ingredients. These samples “add to the available evidence needed to investigate the root cause of this outbreak,” though they don’t provide a conclusive answer, according to the agency.

FDA officials previously suggested that powdered whole milk used in ByHeart formula production might have been a contamination source.

Food safety specialists describe botulism cases from infant formula as extremely uncommon, calling the ByHeart situation unprecedented in both scale and reach.

The illness develops when infants consume botulism spores that grow in their digestive system and create a harmful toxin targeting the nervous system. While death rates previously reached 90%, current treatment methods have reduced fatalities to under 1%.

The sole available treatment involves an intravenous medication called BabyBIG, created from blood plasma donated by adults who received botulism immunization. California’s specialized program serves as the only global supplier of this treatment.

ByHeart held approximately 1% of the American infant formula market and previously distributed roughly 200,000 containers monthly. Parents whose children became ill reported selecting the $42-per-can formula based on its promoted health advantages.