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
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
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
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
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
Thanks to the AP for informing the Public:
Aleccia covers food and nutrition at The Associated Press. She is based in Southern California.As health officials investigate more than 30 cases of infant botulism linked to ByHeart baby formula since August, parents who say their children were sickened with the same illness months
DO NOT CONSUME: Consumers worldwide should not use any ByHeart brand infant formula as all ByHeart products are included in this recall.
The Outbreak: The FDA and CDC, in collaboration with the California Department of Public Health (CDPH), Infant Botulism Treatment and Prevention Program (IBTPP), and other state and local partners, continue to investigate a
