This plant was shuttered before the Botulism Outbreak – for good reasons.
Inspection Report 2022 (483 not issued and Exhibits not provided)
Inspection Report 2023 (Exhibits not provided)
Inspection Report 2024 (Exhibits not provided)
The FDA produced this 2022 483 inspection report – presumably the location of the facility purchased by ByHeart.
Inspection Report 2023 (483 not provided and Exhibits not provided) – “You did not maintain a building used in the manufacture, processing, packing or holding of infant formula in a plain and sanitary condition.” “In informed all
2025 – Consumer complaints of infant illnesses – Salmonella – 8 Complaints, Campylobacter – 1 Complaint 1, E. coli 1 Complaint.
A Clostridium botulinum spore is a tough, dormant form of the Clostridium botulinum bacterium that allows it to survive in harsh environmental conditions for long periods. These spores are widespread in soil, dust, and marine sediments and are generally harmless in their dormant state.
Key Characteristics
• Survival Mechanism: Spores act like a protective shell
Parents in Arizona are reporting that their children became infected with E. coli after interaction with animals at the Arizona State Fair petting zoo.
A non-profit group that works with parents of children infected with the bacteria says at least four children have been hospitalized. All four families told the group — Parker’s Promise —
The FDA has released documents showing that unsanitary conditions at a production plant for ByHeart infant formula and positive tests for pathogens have been going on since at least 2022.
The company is currently under investigation because of an outbreak of infant botulism traced to its powdered infant formula.
As of Nov. 26, there are
We have been retained by 27 families whose infants consumed ByHeart formula. Some of these infants became ill in late 2024 and early to mid 2025.
Updated Case Count: Arizona 3, California 5, Idaho 1, Illinois 2, Kentucky 1, Massachusetts 2, Maine 1, Michigan 1, Minnesota 2, North Carolina 2, New Jersey 1, Oregon 3
IEH Laboratories & Consulting Group tested un-opened cans of ByHeart product. IEH tested thirty-six samples from three lots. IEH found positive test results for Clostridium botulinum Type A in five of the 36 samples across all three lots. Based on these results, ByHeart cannot rule out the risk that all ByHeart formula across all product
November 13, 2025
One additional Washington resident has been added to this outbreak, bringing the total to 10 cases – 9 Washington residents and 1 Oregon resident. All cases report illness onsets before the cheese was recalled on October 24, 2025.
November 6, 2025
Samples of Twin Sisters Creamery cheese have tested positive for two
If parents suspect their child or a doctor suspects a child has developed infant botulism, particularly in relation to consuming ByHeart formula or any other food source, it’s important to take the situation seriously. Here are several key points parents and doctors should be aware of:
Incubation Period: The incubation period for infant botulism can
