I asked our AI friends – What are the pros and cons of replacing FDA Commissioner Makary with me – here is the response? This is a very timely question — Makary resigned as FDA Commissioner today, May 12, 2026, amid reports of internal tensions and policy clashes, with the vaping dispute reportedly being a […]
More recalls to report.
I do not think most of us think just how blessed we are that scientists are doing the hard work creating miracles and that the press reports on it so we can be informed. Thanks to both, and for my clients speaking out too. Here is the AP story: When Alessandro Barbera was rushed to […]
The New York State Department of Agriculture and Markets is urging consumers to avoid drinking raw milk purchased from a Yates County Farm after a state sample tested positive for Salmonella. Inspectors collected a raw milk sample from Galen Burkholder’s farm in Branchport, which returned a preliminary positive result on December 1, according to the […]
Locations: Hawaii Kai warehouse Affected Purchase Dates: November 29, 2025 – December 4, 2025 Hazard: American Nuts, LLC in cooperation with the Food and Drug Administration (FDA) has announced a voluntary recall of this item labeled with Lot Code: 307HMNC25L3, due to the presence of Salmonella. Consumption of Salmonella-contaminated food can cause serious illness.
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 […]