The FDA is investigating an outbreak of “adverse events” related to a frozen food that has been recalled, but the investigation notice does not identify a specific product.

As of June 29 there have been107 people who reported what the Food and Drug Administration is referring to as adverse events. Traceback, testing and on-site inspections are ongoing in addition to the recall of the product.

All facts — including a statement from the company’s CEO — point to the product being Daily Harvest brand frozen French Lentil + Leek Crumbles.

“We have spent the past ten days working with the FDA, state agencies and multiple independent labs, as well as experts in microbiology, food safety and toxicology to conduct testing. These tests cover common foodborne pathogens, toxins, and allergens,” Daily Harvest founder and CEO Rachel Drori said in a written statement released June 27.

She said the company has used an ISO 17025 certified third-party laboratory to test for various bacteria and other pathogens in the product.  

“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.

More than 470 people have reported through various channels that they have become ill after eating the French Lentil + Leek Crumbles. They have similar symptoms including high liver values and quick-onset pain consistent with gall bladder problems.

One attorney who is representing 125 of the sick people says there is “no question that the product is the cause of the illnesses.” That attorney, Bill Marler of Seattle-based Marler Clark LLP, says it is just not yet known what ingredient or chemical is the culprit.

Marler said if it weren’t for the gall bladder patients the symptoms would be consistent with hepatitis infection. Virtually all of his clients have had yellowing of the skin and eyes and dark urine in addition to bad numbers from their liver blood work. Some patients have been hospitalized. He said 20 of them have had their gall bladders removed.

“We are testing more than 40 samples of the crumbles from opened and unopened packages,” Marler said.

He said it is unusual for the FDA to receive more than 100 complaints in such short order related to an individual product. The fact that the company has issued a recall is also an important factor.

Of the patients who have retained Marler the vast majority are 25 to 45 years old and most are women. All of them ate the French Lentil + Leek Crumbles, which just became available to the public in May.

In its outbreak announcement the FDA did not report where the sick people live or provide their age range. The agency did not report what it is testing for or when testing began.

The CEO of Daily Harvest said the FDA and the state Department of Agriculture have each inspected the facility where the French Lentil + Leek Crumbles were manufactured.

“We are confident this issue is limited to our French Lentil + Leek Crumbles and does not impact any of our other 100+ menu items. We are still eating and feeding our families all of our other products,” according to the CEO’s statement.

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