- H.M. was born on September 27, 2024. Plaintiffs began feeding H.M. ByHeart formula on February 17, 2025.
- On March 5, 2025, Plaintiffs noticed that H.M. was unusually lethargic and refusing his bottle. He had been constipated for approximately one week, and Plaintiffs grew suspicious that the
FDA issues Class 1 recall for 3,482,131 cans and 3,531,901 single serve packets of ByHeart Infant Formula due to Botulism Risk
Class I recall: a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
| # | Product Description | Recall Number | Classification | Code Information | Product Quantity | Reason for Recall |
| 1 | 1. ByHeart Whole Nutrition Infant Formula cans 24 OZ 680 grams; |
California, Texas and Arizona hardest hit in ByHeart Botulism Outbreak
States with illnesses: Arizona 5, California 12, Idaho 2, Illinois 2, Kentucky 1, Massachusetts 2, Maine 1, Michigan 1, Minnesota 3, North Carolina 2, New Jersey 1, Ohio 1, Oregon 4, Pennsylvania 1, Rhode Island 1, Texas 8, Virginia 1, Washington 2 and Wisconsin 1.
Illnesses occurred from December 2023 through December 2025.
ByHeart infant
ByHeart Botulism Outbreak jumps to 51 – Illnesses date from December 24, 2023 to December 1, 2025
States with illnesses: Arizona 5, California 12, Idaho 2, Illinois 2, Kentucky 1, Massachusetts 2, Maine 1, Michigan 1, Minnesota 3, North Carolina 2, New Jersey 1, Ohio 1, Oregon 4, Pennsylvania 1, Rhode Island 1, Texas 8, Virginia 1, Washington 2 and Wisconsin 1.
The FDA and CDC, in collaboration with the California Department
Thank goodness for a Free Press and Science
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
Safe Food Coalition urges action on Infant Formula after Botulism Outbreak
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
When is a ByHeart Infant Formula Botulism Recall not a Recall? When it is not!
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
ByHeart needs to step up and pay families medical expenses and lost wages in Botulism Outbreak
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
ByHeart Infant Formula Botulism Outbreak rises to 39 in 18 States
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
4th Botulism Lawsuit filed against ByHeart in Texas Federal Court by Marler Clark
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