Daily Harvest, a frozen vegan meal delivery service, voluntarily recalled one of its frozen packaged products in late June after consumers reported gastrointestinal illness and, in some cases, liver function issues.  

The company is also facing two lawsuits, each alleging the affected product caused its consumers to undergo gallbladder removal surgery.  

Daily Harvest reported in an announcement that it received approximately 470 reports of illness or adverse reactions related to its French Lentil + Leek Crumbles. According to FDA, the agency received 133 consumer adverse event reports (CAERs) across 26 states as of June 28, and 42 required hospitalization.  

The recall comprised approximately 28,000 units of the product, which was distributed between April 28 and June 17 across the continental United States. Rachel Drori, founder and CEO, Daily Harvest, said in a statement on the company’s website that a cause for the related illnesses has not been identified. The products were tested for foodborne pathogens including Listeria, E. coli, Salmonella, Staphylococcus aureus, B. cereus and Clostridium species, as well as for major allergens－all of which came back negative. 

“At this point, despite consulting with numerous experts, cooperating with FDA’s investigation, working with our supply chain, and conducting extensive testing, we have not yet identified a cause,” she said in the statement. 

Drori wrote that the company has expanded testing in search of the “root cause” of the issue, and is also testing for mycotoxins, including aflatoxins, and “less common sources of contamination,” as well as conducting protein and amino acid profiling.  

FDA has launched an investigation to determine, in part, what’s causing the illnesses associated with the Daily Harvest product.  

Carol Ann Ready, who lives in Tulsa, Oklahoma, is one Daily Harvest customer who alleged the lentil crumbles caused abdominal pain, gastrointestinal distress, nausea and headache－ultimately leading to hospitalization and gallbladder removal surgery, according to Marler Clarke, the law firm representing Ready in a lawsuit against the meal delivery company, in a press release. 

Marler Clarke, which specializes in cases involving foodborne illness outbreaks, said in the release it’s been retained by nearly 100 people who reported being affected by the Daily Harvest product. 

Another lawsuit, reported by CNN, was launched on behalf of Luke Wesley Pearson, who lives in Portland. Pearson, too, alleged the product caused illness followed by hospitalization and gallbladder removal surgery, CNN reported.  

According to Daily Harvest, none of its other products have been affected. The company said in the announcement that customers were notified about the affected product via email, and those who purchased the product were issued a credit and asked to dispose of the product.