Although the FDA does not out Daily Harvest by name, over the last week I have directed over 100 people to report their illnesses to the FDA. Of note is that a recall was initiated and the only frozen food recall in the last week has been the Daily Harvest French Lentil + Leek Crumbles.

Since this outbreak broke (thanks to social media – TikTok, Instagram, Twitter and various online platforms – Reddit), we have been contacted and retained by over 125 people – mainly women between the ages of 25-45. They are all active, health conscious and sick with nearly identical symptoms of acute liver failure. Collectively, their liver function tests were extremely elevated. Some have dropped and some have not. At lease 20 people have endured their gall bladder being removed. All are worried about the long-term impacts on their health by an ingredient causing the illness, that to date has not been determined after extensive blood work, imaging and live biopsies.

Thankfully, many of the people did not take Daily Harvest’s advice and throw the product out. We are in the process of gather leftover product – about 40 opened and unopened bags – and having it tested for a broad range of toxins and chemicals. Hopefully between our tests and the testing being done by Daily Harvest and the FDA, we will figure out what is causing these illnesses, and what, if any, long-term impacts are of concern.

We have been retained by nearly 100 individuals who have suffered nearly identical symptoms – liver and gall bladder disfunction with exceeding abnormal liver function. Many have been hospitalized, undergoing numerous tests and procedures, including surgery.

GENERAL ALLEGATIONS

The 2022 Outbreak Linked to Daily Harvest French Lentil + Leek Bowls

3.1       According to the U.S. Food and Drug Administration, on June 19, 2022, Defendant Daily Harvest instituted a voluntary recall of approximately 28,000 units of French Lentil + Leek Crumbles produced between April 28 and June 17, 2022.
3.2       More than 470 instances of consumers experiencing illness or adverse reactions after consumption of the French Lentil + Leek Crumbles have been reported. The consumption of Defendant’s products has caused an array of serious health complications, from gastrointestinal illness to liver and gallbladder dysfunction.
3.3       Daily Harvest has stated that the approximately 28,000 units of the product were distributed to customers in the United States through direct online sale and through retail sales at stores in Chicago and Los Angeles. Daily Harvest also provided samples to a small number of customers and social media influencers.
3.4       The French Lentil + Leek Crumbles was a frozen, pre-made product packaged in a 12oz white pouch with the Daily Harvest logo at the top, “CRUMBLES” printed immediately below, and “French Lentil + Leek” printed in bold.
3.5       All lots of the French Lentil + Leek Crumbles product were ultimately recalled by the Defendant.

Facts Relating to Defendant’s Manufacture, Distribution, and Sale of Contaminated, Defective Food Products that Caused Plaintiff’s Injuries

3.6       On April 28, 2022, Defendant announced the launch of the “Crumbles” product line, including the now-recalled French Lentil + Leek Crumbles.   
3.7       Defendant marketed these French Lentil + Leek Crumbles as a convenient, pre-made item that, after sauteing, can be added to other products, including other those produced and marketed by the Defendant, for a complete meal. Defendant marketed the Crumbles as “planet-friendly to add more nourishing plant protein into” customers’ diets.   
3.8       Defendant’s promotional materials state (as quoted here) that a “team of chefs and nutritionists” created the French Lentil + Leek Crumbles recipe, and that the product was an “easy to prepare and ready in minutes” way to lower customers’ carbon footprint, and potentially “help you live longer.” 
3.9       Defendant claims to work directly with farmers to grow organic products and “increase biodiversity” while avoiding synthetic chemicals.
3.10     Defendant manufactures, packages, distributes and/or sells, directly all of its products, including the French Lentil + Leek Crumbles, to customers through online sales, through its own standalone retail stores in Chicago and Los Angeles. Additionally, Defendant provides samples to a small number of customers, including social media influencers, to increase visibility and, ultimately, sales of the products.
3.11     Plaintiff purchased through online subscription  Defendant’s French Lentil + Leek Crumbles and on two occasions consumed it. The product was contaminated and caused Plaintiff’s injuries described below.
3.12     The French Lentil + Leek Crumbles consumed by Plaintiff contained contaminated ingredients, manufactured, packaged, distributed and/or sold by Defendant.   

Copy of the complaint – https://www.marlerblog.com/files/2022/06/Complaint-2.pdf

On April 28, 2022, Daily Harvest announced the launch of Crumbles, a versatile plant-based crumble made entirely from real ingredients like lentils, nuts, seeds, and vegetables.

Of note, some “influencers” received the product earlier and became part of the statistics of the hundreds with severe liver disfunction.  A key question is when Daily Harvest was made aware of the mounting illness.

Since Monday we have been contacted by nearly 100 consumers who have suffered nearly identical symptoms.  Here is one example of a young woman who had her gallbladder removed yesterday:

Headache, nausea, vomiting, skin sensitivity and stomach sensitivity were also symptoms. The headache, nausea and vomiting accompanied the worst pain in the evening and lasted for several hours to a few days. Severe abdominal pain in the upper right quadrant. Right shoulder pain. Pain was sharp. The pain got worse over time and the first time it lasted for 72 hours. I had some stomach sensitivity though for 120 hours total. The second time I experienced intense pain for 120 hours and I am still feeling pain. The pain came on around 7 am on Sunday, May 29th and is ongoing although less severe right now. I am getting my gallbladder removed as a result. 

Here is another one:

I was recently hospitalized for 8 days, on the 3rd day considered for ICU admission and instead transferred to a tertiary care center 3 hours from home due to acute liver failure.  I had a 103 fever packed in ice for days, vomiting and severe stomach and rib pain.  My platelets, gallbladder, liver and neurological system were all effected.  As well, I am a nursing mother to a four month old baby girl.  Elevated Liver Enzymes (800+), gallbladder injury, kidney injury, fluid in ureters, dark urine, high billirubin, ketones in urine, fever 103F for 3 days, severe headache, pressure in base of skull, limited range of motion, sensitivity to light, double vision, abnormal reflex and neurological tests, confusion, dizziness, numbness in hands, feet and face, vomiting, nausea, severe abdominal pain, liver pain, frequency of urination, stopped menstruation, abnormal hormone levels, see labs attached for additional high and low lab reports, severely lowered platelets

According to the April 28, 2022, press release, “Consumers now have a people and planet-friendly way to add more nourishing plant protein into their diets. Crumbles offer 13 grams of protein per serving and are free of gums, fillers, hydrogenated oils, GMOs, or artificial anything. Just sauté, then add to tacos, pasta sauces, Daily Harvest Flatbreads, and more. Crafted by Daily Harvest’s team of chefs and nutritionists, Crumbles are launching in two mouth-watering varieties: Walnut + Thyme and French Lentil + Leek. Both are savory, herbaceous, and seasoned to perfection, yet versatile enough to use as a base for different recipes. The new collection is easy to prepare and ready in minutes, offering a simple way to integrate more nuts, seeds, legumes, and veggies into diets – and make a difference for the planet.”

However, after hundreds of customers reported – now likely over 500, Daily Harvest recalled the French Lentil + Leek Crumbles on June 23, 2022.

According to Daily Harvest, “From April 28 to June 17, 2022, approximately 28,000 units of the recalled product were distributed to consumers in the continental United States through online sales and direct delivery, as well as through retail sales at the Daily Harvest store in Chicago, IL and a “pop-up” store in Los Angeles, CA. Samples were also provided to a small number of consumers. 

French Lentil + Leek Crumbles is a frozen product packaged in a 12oz white pouch with the words “Daily Harvest” at the top, a large “CRUMBLES” immediately below the top and the words “French Lentil + Leek” in bold, as shown below. All lot codes of the French Lentil + Leek Crumbles are affected.  No other Daily Harvest products are affected or part of this recall.

To date, the company has received approximately 470 reports of illness or adverse reactions. Consumer safety is our highest priority, and we have taken immediate steps to stop production and distribution of the product and conduct a root cause investigation, which is ongoing. This recall is being made in cooperation with the U.S. Food and Drug Administration.  

Here are a few suggestions to victims:

1. Protect your heath – seek prompt medical care.

2. DO NOT, as Daily Harvest suggests, “dispose of it.” The product can be tested.

3. Do not eat the product.

4. Report your illness to the FDA at 866-300-4374

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According to the FDA, Daily Harvest has voluntarily recalled all French Lentil + Leek Crumbles due to consumer reports of gastrointestinal illness and potential liver function issues. 

From April 28 to June 17, 2022, approximately 28,000 units of the recalled product were distributed to consumers in the continental United States through online sales and direct delivery, as well as through retail sales at the Daily Harvest store in Chicago, IL and a “pop-up” store in Los Angeles, CA. Samples were also provided to a small number of consumers. Daily Harvest directly notified by email those consumers who were shipped the affected product, and other consumers for whom the company had contact information, and consumers were issued a credit for the recalled product.

French Lentil + Leek Crumbles is a frozen product packaged in a 12oz white pouch with the words “Daily Harvest” at the top, a large “CRUMBLES” immediately below the top and the words “French Lentil + Leek” in bold, as shown below. All lot codes of the French Lentil + Leek Crumbles are affected.  No other Daily Harvest products are affected or part of this recall.

To date, the company has received approximately 470 reports of illness or adverse reactions.

This recall is being made in cooperation with the U.S. Food and Drug Administration.

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  1. Protect your heath. Seek prompt medical care.
  2. DO NOT, as Daily Harvest suggested, “to dispose of it.” The product can be tested for pathogens, allergens and chemicals.
  3. Do not eat the product.
  4. Report your illness to the FDA.  Here are the links:  Phone the FDA Main Emergency Number at 866-300-4374 or phone the Consumer Complaint Coordinator for your state or area.

According to the Washington Post: Daily Harvest, a service that offers home deliveries of vegan frozen food it claims is good for consumers and the environment, is grappling with allegations that one of its products sickened people. The celebrity-backed company is “working with a group of experts to help us get to the bottom of this” after complaints from customers who said they had experienced stomach, liver and gallbladder issues after eating its French leek and lentil crumble, enlisting the Food and Drug Administration, “microbiologists, toxin and pathogen experts as well as allergists” to identify any problems, it said in a note to customers posted Wednesday on Instagram.

“All pathogen and toxicology results have come back negative so far, but we’re continuing to do extensive testing and will keep you updated,” the company wrote in the post.

The company on Sunday said it had advised anyone who had purchased the product — a blend that includes lentils, butternut squash, quinoa, hemp seed and cremini mushrooms and was marketed as a crunchy plant-based topping — to dispose of it.

We have been contacted by nearly two dozen people who have been suffering a range of severe digestive issues, including liver complications. Many have been hospitalized, with some suffering ongoing symptoms. We have multiple samples of the French leek and lentil crumble out to labs for testing.

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According to press reports, the U.S. Food and Drug Administration said on Wednesday it was notified of one more infant death in January potentially related to Abbott Laboratories’ baby formula and the agency has started a probe.

Abbott initiated a recall of its infant formula products and closed its Michigan plant in February after reports of serious bacterial infections in four infants, worsening a shortage among multiple manufacturers that began with pandemic supply chain issues.

The date of death and state of death was not announced. The FDA apparently became aware of the death on June 10, 2020. So far, the FDA has received 129 complaints linked to Abbott formula products, including 119 since the product recall in February.

According to the FDA, this would bring the total to five illnesses with three deaths.

Total Adverse Events: 5
Hospitalizations: 5
Reported Deaths: 3
Illness Onset Date Range: 9/6/2021 – 1/4/2022 – new case not yet reported
States with Adverse Events: MN (1), OH (2), TX (1) – new case not yet reported
Product Distribution: Nationwide and International

The facility is now set to reopen, but not before the U.S. Attorney sued Abbott and several employees. In the complaint, filed by the U.S. Department of Justice on behalf of the FDA, the government alleges that powdered infant formula products manufactured at Abbott Nutrition’s Sturgis facility were adulterated because they were made under insanitary conditions and in violation of current good manufacturing practice requirements.

Abbott is essentially confessing to the violations in the below consent decree. Under the proposed consent decree, Abbott Nutrition will be required to retain an independent expert to review the Sturgis facility’s operations to ensure compliance with the law. It also includes requirements for testing products, as well as ceasing production, and promptly notifying the FDA should contamination be detected. The proposed consent decree also requires the implementation of a sanitation plan, environmental monitoring plan and employee training programs.

Here are the key documents:

Here is the 2021 inspection report at the plant – APPLIED – FOI II – BR Abbott Nutritions- FEI# 1815692 9-2021 EIR.

Here are the whistleblower documents – Redacted Confidential Disclosure re Abbott Laboratories – 10-19-2021_Redacted (1)

Here is the 2022 inspection report at the plant – Updated Final Applied_Unapplied Redactions Abbott Nutrition Sturgis FEI 1815692 FDA 483 1-31022 to 3-16-22 – ISSUED_Redacted

Here is the complaint – abbott_complaint_0

Here is the consent decree – abbott_proposed_consent_decree_0

Please read the above and ask the question: is this how infant formula should have been manufactured?

Today the FDA added two new Salmonella Outbreaks that have sickened 53 to its investigation chart. No other information – type of product or states of illness were added. Three other outbreaks – 2 Listeria and 1 E. coli O157:H7 (sickening a total of 41) are also listed as products not identified. Strawberries have been linked to a Hepatitis A outbreak and Peanut Butter to a Salmonella outbreak. Dry cereal still lists pathogen or cause of illness as unknown.

Just received this from a client that received it from Daily Harvest – Please do not dispose the evidence – we can connect you to a lab that will test the product. We are presently testing a dozen samples.

Hi __________,

I want to make sure you have the latest update on our voluntary recall of French Lentil + Leek Crumbles. We are taking this very seriously and doing everything we can to get to the bottom of this. Your health and well-being are our top priority.

Here are the steps we are taking: As soon as we received reports suggesting a possible link between the French Lentil + Leek Crumbles and an adverse reaction, we immediately took action and launched a voluntary recall.

We have reached out multiple times directly to consumers who received the product, instructing them to dispose of it and not eat it. If you have French Lentil + Leek Crumbles, please dispose of them and do not eat them. The last thing we’d want is for anyone else to be impacted.
In parallel, we launched an investigation to identify the root cause of the health issues being reported. We’re working closely with the FDA and with multiple independent labs to investigate this. We are working with a group of experts to help us get to the bottom of this—that includes microbiologists, toxin and pathogen experts as well as allergists.

All pathogen and toxicology results have come back negative so far, but we’re continuing to do extensive testing and will keep you updated.

We are in touch directly with customers who reported adverse reactions and are collecting data to further the investigation, as well as offering refunds. If you have been impacted and are not already in touch with our team, please go here to begin a report or email us at crumbles-recall@daily-harvest.com.We are doing everything we can, as quickly as we can to identify the root cause. Nothing matters more than the health and safety of our customers and we deeply value the trust you put in us and our food every day. We will update you as soon as we know more. Please reach out if you have any questions.

According to several news reports and social media posts, a popular meal delivery service has recalled a lentil-based food product after days of customers posting online about gastrointestinal issues they faced after they ate the French Lentil + Leek Crumbles meal. 

Daily Harvest posted a recall statement on its website Sunday. NBC News viewed an email it sent Friday asking a customer to throw away the lentils “out of an abundance of caution” and offering a $10 credit for every bag of the product that was purchased. 

“A small number of customers have reported gastrointestinal discomfort after consuming our French Lentil + Leek Crumbles,” the email said. “As included in our cooking instructions, lentils must be thoroughly cooked to an internal temperature of 165°F.”

In its recall statement, Daily Harvest wrote that it “launched an investigation with internal and external experts throughout our supply chain and in accordance with regulatory procedures.” 

The above has not made it to the FDA’s Outbreak Investigation page, nor the private reporting site www.iwaspoisoned.com – yet. As of this morning it is unclear what might be causing the illnesses reported on social media possibly linked to Daily Harvest. At this time it is unclear if a solid pathogen link will be found, or if like the below, they remain a mystery.

Starting in late 2021 Lucky Charms food poisoning reports started to trend on iwaspoisoned.com. Now there are reports of over 7,300 sick. and the FDA has initiated an investigation.  We recommend anyone who fell ill after eating Lucky Charms, to report it, and to keep left over product for testing. We will communicate procedures for testing to everyone  who reports their case.  See link.

Food poisoning reports for Cheerios breakfast cereal started to trend in Q1 2022. Iwaspoisoned.com now has reports of over 360 persons reported sick citing Cheerios. If you got sick after eating Cheerios. We recommend consumers report it, and keep leftover product for testing. We will communicate procedures for testing to everyone who reports their case. See link.