51 Infants Hospitalized in Alarming Surge (Image Credits: Foodsafetynews.com)
Federal authorities pinpointed organic whole milk powder from an unnamed supplier as the source of Clostridium botulinum contamination in ByHeart infant formula, which hospitalized 51 infants across 19 states.[1][2]
51 Infants Hospitalized in Alarming Surge
The outbreak marked the first documented U.S. case of infant botulism tied to contaminated formula. Illnesses surfaced as early as December 2023 and continued through early December 2025, with no new confirmations since December 10.[3] All affected infants, ranging in age from 16 to 264 days, required hospitalization and treatment with BabyBIG, an antitoxin specific to infant botulism. No fatalities occurred, though symptoms included constipation, poor feeding, weak cry, loss of head control, and breathing difficulties.
Health officials expanded their case definition to include any infant exposed to ByHeart Whole Nutrition formula since its March 2022 release. Epidemiologic data strongly linked consumption of the product to every illness. Cases spanned 19 states: Arizona, California, Idaho, Illinois, Kentucky, Massachusetts, Maine, Michigan, Minnesota, North Carolina, New Jersey, Ohio, Oregon, Pennsylvania, Rhode Island, Texas, Virginia, Washington, and Wisconsin.[2]
Investigators Zero In on Raw Ingredient
Laboratory analysis through whole genome sequencing provided the breakthrough. FDA tests confirmed Clostridium botulinum type A toxin in unopened ByHeart formula samples, matching clinical isolates from sick infants. Further scrutiny revealed identical strains in organic whole milk powder, a key ingredient sourced from a third-party supplier.[1]
ByHeart’s own mid-December testing corroborated the findings, detecting the toxin in six of 36 finished product samples from recalled batches 251261P2 and 251131P2. FDA investigators collected additional milk powder samples at a processor for the supplier, with results from the New York Wadsworth Laboratory showing a genetic match. Neither the FDA nor CDC disclosed the supplier’s identity or details on its other customers.
The agency noted that such contamination posed unique risks in powdered formula, where heat-resistant spores could persist despite processing.
Swift Recall and Retailer Crackdown
ByHeart initiated a voluntary recall of two specific lots on November 8, 2025, before expanding it to all Whole Nutrition infant formula products, including cans and single-serve sticks. The products represented about 1% of U.S. infant formula sales and reached international markets as well. Parents received urgent directives to discard any remaining formula and monitor infants for symptoms.
Despite the recall, FDA inspectors found products lingering on shelves. The agency issued warning letters to major retailers including Walmart, Target, Kroger, and Albertsons on December 12, emphasizing legal obligations under the Federal Food, Drug, and Cosmetic Act. Some stores faced scrutiny for inadequate removal efforts even weeks later.
Unraveling Botulism’s Detection Challenges
Confirming Clostridium botulinum proved arduous due to its spore-forming nature. Spores demanded special activation for detection, specialized equipment, and confirmatory tests that spanned two weeks or more. Limited lab capacity nationwide compounded delays, as only select facilities handled such analyses.
ByHeart’s manufacturing facility had drawn prior FDA scrutiny in February for objectionable conditions, though the outbreak probe focused primarily on the upstream supplier.
Food safety attorney Bill Marler highlighted lingering uncertainties, questioning the supplier’s distribution to other products and potential ties to unreported cases.
Key Takeaways
- 51 infants hospitalized nationwide from ByHeart formula contaminated with botulism toxin.
- Organic whole milk powder from unnamed supplier matched outbreak strain via genome sequencing.
- Full recall issued; consumers urged to discard all ByHeart products immediately.
This outbreak underscores vulnerabilities in the infant formula supply chain, where a single tainted ingredient rippled across the nation. As investigations continue, parents remain vigilant for symptoms in at-risk infants. What steps should formula makers take next to prevent repeats? Share your thoughts in the comments.
