FDA officially names Daily Harvest crumbles as being under investigation for illnesses

Two weeks after the company began receiving reports of liver failure the FDA has announced it is investigating an outbreak of “adverse reactions” to Daily Harvest brand French Lentil & Leek Crumbles.

As of June 28 the Food and Drug Administration had received at least 133 reports of what it calls adverse events from consumers who ate the frozen crumbles product, according to an announcement this afternoon. The implicated product was shipped nationwide.

The company recalled the product on June 17 after receiving complaints from consumers of gastrointestinal illnesses and abnormal liver function. Some patients also reported having to have their gall bladders removed. More than 470 reports of illnesses have been reported via various channels, including social media, the FDA’s reporting system, and to food safety attorneys.

“In response to Consumer Adverse Event Reports (CAERS) and Consumer Complaints submitted to the FDA, the FDA has initiated an investigation, including an inspection and sample collection in an effort to determine the cause of illnesses. As of June 28, the FDA has received 133 CAERS reports and Consumer Complaints related to this product,” according to the FDA’s notice today.

From April 28 to June 17, about 28,000 packages 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 reported emailing consumers who were shipped the affected product, and other consumers for whom the company had contact information. The company issued a credit for the recalled product. Both the company and the FDA are recommending that consumers dispose of the recalled product, however a Seattle-based food safety attorney has different advice.

Bill Marler, whose law firm is representing more than 125 sick consumers, suggests that consumers retain the product, especially if they have unopened packages, so that it can be tested for pathogens and other toxins. No one who has the recalled product should continue to eat it.

Marler’s firm has sent about 40 samples of opened and unopened product to accredited third-party laboratories for testing so far. 

Of the 125 patients he is representing, Marler said most are women between the ages of 25 and 45. The patients have many symptoms consistent with a liver disease such as hepatitis, but at least 20 of them have had to have their gall bladders removed.

FDA’s investigation is ongoing, and more information will be provided as it becomes available, according to the agency.

“If you experience symptoms including yellowing of the skin and eyes (jaundice), dark urine, itching with no rash, gastrointestinal illness, nausea, fatigue, body aches, severe abdominal pain and/or fever after consuming this product, please consult with your healthcare provider. Let your healthcare provider know you have recently consumed the recalled Daily Harvest French Lentil & Leek Crumbles. Healthcare providers should report these illnesses to their health department,” the agency reported in its notice today.

Of the 133 consumer complaints received by the FDA, 42 people required hospitalization. Onset of the most recent FDA confirmed illness was June 21.

States where sick people live are California, Colorado, Connecticut, Florida, Georgia, Illinois, Iowa, Indiana, Massachusetts, Maryland, Michigan, Missouri, Montana, New Hampshire, New Jersey, New York, North Carolina, Ohio, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Virginia, Washington and Wisconsin.

The FDA advises that consumers who have symptoms should contact their health care provider to report their symptoms and receive care.

To report a complaint or adverse event such as illness or serious allergic reaction consumers can:

• Call an FDA Consumer Complaint Coordinator if you wish to speak directly to a person about your problem.
• Complete an electronic Voluntary MedWatch form online.
• Complete a paper Voluntary MedWatch form that can be mailed to FDA.

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