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 Safe Food Coalition wants stronger oversight of infant formula production and the reinstatement of FDA food inspectors, citing the ongoing outbreak of botulism infections as a case in point.
The coalition includes the Center for Food Safety, Center for Science in the Public Interest (CSPI), Consumer Federation of America, Consumer Reports, Government Accountability Project, GWU
Retailers around the world are urged to pay attention. Selling recalled product – especially infant formula with botulism – is a bad idea for your customers and a bad idea for your liability exposure – including punitive damages.
As of last week the FDA continues to receive reports that recalled formula is still being found
Last night I spoke to a family whose child suffered infant botulism after consuming ByHeart formula. The child was hospitalized for weeks, including time in ICU and on a feeding tube, and received live-saving BabyBIG botulism anti-toxin. Medical expenses and lost wages are in well into six figures – actually, nearly $250,000. They also learned
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
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
