Marler Clark files 4th Botulism Lawsuit against ByHeart in Texas Federal Court

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 next days, K.P.’s appetite decreased and he appeared constipated.

By November 15th, K.P.’s cry was weak and he was having difficulty keeping his head up when on his stomach.  K.P. refused both breast milk and a bottle.

On November 16th, K.P. seemed “floppy.”  He was taken to Methodist Hospital ER.  The physicians were concerned about his “head lag and droopiness.”

The family informed them that K.P. had been consuming ByHeart formula. Given the recall and the symptoms consistent to botulism, K.P. was transferred to Texas Children’s Hospital for emergency care via ambulance. As seen from a mother’s perspective: 

“I just remember a lot of hours (4pm-10pm) being spent in the ER where he was poked and prodded and monitored. We tried feeding him a bottle and he only took about 3 ounces which took 30-40 minutes for him to finish. They had to take blood, insert a catheter to collect pee, and check his stats to make sure his stats were okay. I remember the ER telling us they needed to insert a new IV before he was moved to the PICU. Because he was a baby, it’s harder to see his veins and insert an IV . The nurses came and tried about three or four times to get an IV started. he bled so much and, in the end, they had to call a nurse to do an ultrasound to locate a vein and put in an IV. By the end of it all, his hands were so blue and seemed to be bruised. Around 10 pm, he was transferred to the PICU. The nurses had to put a bunch of wires on him to monitor him, and we were told he couldn’t eat in case he needed to be intubated as he could aspirate. That night the only thing he was able to drink was small packets of sugar water – it was so horrible seeing him be so hungry and sick.”

The following day K.P.’s symptoms worsened.  He was so weak, that the decision was made to intubate him and her remained so for three days.  For nutrition, he was placed on a feeding tube.

K.P. was given the botulism anti-toxin, BabyBig, which was flown in from California.

On November 25^th, K.P. was able to be released; however, he is still weak and recovering. In the end, it was a parent’s worst nightmare: 

I’m not sure words can describe the impact this situation had on my son and our entire family. As a mother, this was the most stressful and painful thing I have ever endured. No one expects their 4-month-old to be sick to the point of intubation – especially from something like baby formula, one of the safest and trusted items out there. When he got sick, we didn’t even think it was due to botulism because even after the recall, we had some sort of trust in ByHeart and assumed it was a minor mistake from the company. We did not realize how massive the issue would become. I initially exclusively breastfed our son, but I had to consider formula because I was not making enough. I already felt guilty as a mother for not being able to give him what he needed, but I knew I had to feed him to ensure that he was growing and getting the appropriate amount of milk to meet his nutritional needs. I researched and looked at many baby formulas, reading through reviews and parent experiences to get him the best on the market. I ended up landing on ByHeart, thinking it would be perfect for my child. We didn’t even have much time to process the fact that he had to be intubated and there were also some complications with intubation, as it took three tries for him to be intubated. We watched his oxygen go down with every try- it was extremely scary and we were worried he might not make it. Watching my little baby go through so much at such a young age will never leave my mind. It was an awful situation that took a toll on my mental and physical health. I feel guilty that I chose to give my child something that could have potentially killed him – nothing will ever change that. My family and I now worry that something like this will happen again every time we give him a bottle of milk – that fear will never go away. I am constantly worried about the long-term impacts this incident will have on him. I know most children recover fully, but a 4-month-old should not have to worry about recovering from something like this – he should be able to eat, sleep, play like any other baby.

K.P. tested positive for botulism and has been linked to the ByHeart infant Formula Outbreak.

ByHeart, Inc. is the parent company for three manufacturing / packaging facilities:

• Blendhouse LLC (Reading, PA), a manufacturing site. Closed in 2024.
• Blendhouse Allerton, LLC (Allerton, IA), a manufacturing site. 
• Blendhouse Portland LLC (Portland, OR), a packaging site.

The FDA inspected the Blendhouse Allerton facility in 2025 (where product was manufactured). Its Inspection Report stated:

At the close-out of the inspection, a Form FDA 483, Inspectional Observations, was issued for 3 items, along with 2 “Additional Observations”, and 7 “General Discussion with Management”. The three 483 items included, receiving, and releasing ___________ ingredient used in infant formula base powder that was not held under conditions to prevent adulteration, not taking actions to eliminate all potential harborage areas when issues with rodent arose during the year 2024-2025; and not monitoring the floor conditions adequately at the dryer ____ (level __ and level __) when there were findings of confirmed Cronobacter Sakazakii. The two additional observations consists of the firm not having clear barriers separating hygiene zones; and not monitoring bathhouse differential pressures.

Also shared with the firm on February 14, 2025, was that the FDA observed “consecutive ___ pest control service tickets between October 2024 and December 2024 that reported up to 200 large black flies caught in insect light traps in the IF ____ .” 

On reviewing the Allerton pest management program, inspectors documented multiple instances of rodent activity. Additionally, FDA inspectors took exception to the company’s approval and release for use on more than one occasion of an ingredient that was part of a shipment showing evidence of rodent activity, including rodent excreta and torn bags.

During the closeout discussion, Kathleen Whitesell, the Senior Director of Food Safety, who oversees food safety and quality for all three ByHeart locations, insisted that the rodent infestation did not represent a food safety concern, due to the existence of a ‘kill step.’ In response, the FDA investigators reminded the firm that “…although there may be a ‘kill step,’ it is not a good practice to add to the microbial load…” prior to that step.

Further, Form 483 2025 stated: “Observation 1: You approved and released for use an ingredient that was not manufactured, packaged, labeled, or held under conditions to prevent adulteration.” “Observation 2: You did not exclude pests from your food plant to protect against contamination of food.” “Observation 3: You did not maintain a building used in the manufacture, processing, packing or holding of infant formula in a clean and sanitary condition.”

The FDA also inspected the Blendhouse Portland facility in 2025 (where product was blended). Its Inspection Report found consumer complaints of infant illnesses: Salmonella – 8 Complaints, Campylobacter – 1 Complaint 1, E. coli – 1 Complaint.

The United States Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (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 multistate outbreak of infant botulism. Epidemiologic and laboratory data show that ByHeart Whole Nutrition infant formula might be contaminated with Clostridium botulinum, a bacterium which is causing infant illness in multiple regions of the country.

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 lots) have been reported from 17 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 3, Pennsylvania 1, Rhode Island 1, Texas 8, Washington 2, and Wisconsin 1. Laboratory confirmation for some cases is ongoing. All 37 infants were hospitalized and treated with BabyBIG®, a specific botulism immune globulin treatment. No deaths have been reported to date. For 35 infants with age and sex information available, they range in age from 16 to 264 days and 15 (43%) are female. For 36 cases with illness onset information available, illnesses started on dates ranging from August 9 to November 19, 2025. 

As part of this investigation, officials in several states have collected leftover infant formula for testing. On November 8, 2025, preliminary laboratory results reported by the California Department of Public Health suggest the presence of the bacteria that produce botulinum toxin in an open can of ByHeart infant formula (lot 206VABP/251131P2) that was fed to an infant with infant botulism. Additional testing is underway, and results are expected in the coming weeks. Detection of Clostridium botulinum in infant formula is difficult, and a negative test result does not rule out the presence of the bacteria in the product. As part of the investigation, ByHeart tested unopened infant formula products retained at its facility. According to ByHeart, third party laboratory analysis of some of these samples identified Clostridium botulinum, which produces the toxin that is making infants sick in this outbreak.

FDA has received reports that recalled formula is still being found on store shelves in multiple states, including at multiple Walmart, Target, and Kroger locations, and at one or more Sprouts Organic Market, Safeway, Acme, Jewel-Osco, Shaw’s, Star Market, Smith’s, King Sooper’s, Albertson’s, Whole Foods, Wegman’s, and Publix locations. FDA is working with state partners and retailers to ensure an effective recall and immediate removal of these products from store shelves across the country. All ByHeart infant formula products have been recalled, and these products should not be available for sale in stores or online. This includes all formula cans and single-serve “anywhere pack” sticks. 

Recalled products were sold through online marketplaces and were shipped to customers outside of the United States. Consumers worldwide should not use any ByHeart brand infant formula as all ByHeart products are included in the recall. Customer information provided by Amazon shows that a limited quantity of recalled ByHeart infant formula was distributed to Argentina, Brazil, Brunei, Canada, Chile, China, Colombia, Ecuador, Egypt, Hong Kong, Israel, Jamaica, Japan, Republic of Korea, Peru, Philippines, Romania, Singapore, South Africa, Thailand, and Virgin Islands.

Republished with permission from Bill Marler and Marler Clark. Copyright (c) Marler Clark LLP, PS. All rights reserved.

Source: https://www.marlerblog.com/case-news/marler-clark-files-4th-botulism-lawsuit-against-byheart-in-texas-federal-court/