This is simply unacceptable. This botulism outbreak, frankly any outbreak that sickens babies, should never have happened. We can do more to protect the most vulnerable. The stork in “operation stork speed” clearly flew into a brick wall and crash landed. This child’s parents bought ByHeart Infant Formula at a Walmart. ByHeart utilized powdered organic […]
Adriana Zimova, JD, MPA, joined Marler Clark as a Litigation Attorney in October 2025. Adriana earned her JD from Harvard Law School, cum laude, and her MPA in International Development from Harvard Kennedy School. Following graduation from law school, Adriana joined Cleary Gottlieb Steen & Hamilton LLP in Washington, DC, where she represented multi-national corporations in […]
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 4, Pennsylvania 1, Rhode Island 1, Texas 8, Virginia 1, Washington 2, Wisconsin 1. The FDA and CDC, in collaboration with the California Department of Public Health (CDPH), Infant Botulism […]
Full Complaint: https://www.marlerblog.com/files/2025/12/FS-Pls-Original-Complaint.pdf K.P. was born on July 11, 2025. Plaintiffs began feeding K.P. ByHeart formula on September 30, 2025. In hindsight, K.P. started to exhibit symptoms on November 6th, ten days before hospitalization and three days before he stopped consuming ByHeart infant formula. K.P. was becoming increasingly fussy as well as sleeping during the day. Over […]
The FDA has published the following warning: Consumers worldwide should not use any ByHeart brand infant formula as all ByHeart products are included in this recall. As we know, as of November 26, 2025, a total of 37 infants with suspected or confirmed infant botulism and confirmed exposure to ByHeart Whole Nutrition infant formula (various […]
Hello, FDA, CDC and the State of Texas – time to reopen this investigation. My client, John, died a few days ago. He was a 56-year-old resident of Texas with no underlying illnesses when he developed listeriosis on July 16, 2024. Complications of that infection severely and permanently compromised his cognitive function. His Listeria monocytogenes isolate has […]
I wonder who did third-party auditing? Did retailers – online or big box – ever do an independent audit? Subpoenas to follow. Inspection Report 2025 (Exhibits not provided) – “At the close-out of the inspection, a Form FDA 483, Inspectional Observations, was issued for 3 items, along with a ‘Additional Observations,’ and 7 ‘General Discussion with […]
This plant was shuttered before the Botulism Outbreak – for good reasons. Warning Letter 2023 Inspection Report 2022 (483 not issued and Exhibits not provided) Inspection Report 2023 (Exhibits not provided) 483 2023 Inspection Report 2024 (Exhibits not provided) 483 2024
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 […]
2024 seemed uneventful. 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, encasing the key parts of the […]
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 — that their […]
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, Pennsylvania 1, Rhode Island 1, Texas 8, Washington 2 and Wisconsin 1. The FDA and CDC, in […]
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 lots may […]
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 […]