U.S. Food and Drug Administration (FDA) Investigation of Illnesses Linked to Frozen Lentil Crumbles (2022)

From June to October 2022, the U.S. Food and Drug Administration (FDA) investigated nearly 400 reports of illness, many of them involving the liver, bile ducts or gallbladder, in people who had eaten a recalled frozen lentil and leek crumble sold by a direct-to-consumer frozen food company. The investigation did not name a cause. In May 2024 the U.S. Food and Drug Administration separately determined that one of the product’s ingredients, tara flour, is an unapproved food additive in human food, while stating that it had found no evidence that tara flour caused the outbreak.

This page reports what the U.S. Food and Drug Administration’s own documents say: the recall and the U.S. Food and Drug Administration investigation, the symptoms reported, how the count of reports grew, what the U.S. Food and Drug Administration told consumers, the 2024 tara flour determination, what the investigation does not show, its status as of October 18, 2026, and how it fits other U.S. Food and Drug Administration food actions. No company, brand or product name is used here. The illnesses described concern one recalled product; the U.S. Food and Drug Administration did not implicate lentils or leeks as foods. The food itself is described on the site’s Lentils page.

Table of Contents

  1. What the U.S. Food and Drug Administration Did, June–October 2022
  2. The Recall and Where the Product Went
  3. The Illnesses Described in the Reports
  4. How the Number of Reports Grew
  5. How the U.S. Food and Drug Administration Investigated
  6. What the U.S. Food and Drug Administration Told Consumers and Clinicians
  7. The 2024 Tara Flour Determination
  8. What the Investigation Does Not Show
  9. Dates and Status as of October 18, 2026
  10. How It Fits Other U.S. Food and Drug Administration Food Actions
  11. Primary Documents
  12. Key Research Papers
  13. Connections
  14. Featured Videos

1. What the U.S. Food and Drug Administration Did, June–October 2022

The U.S. Food and Drug Administration’s investigation page, titled “Investigation of Adverse Event Reports” and dated June 2022, states that the U.S. Food and Drug Administration, “along with U.S. Centers for Disease Control and Prevention (CDC) and state and local partners,” investigated consumer complaints of “gastrointestinal illness and liver, bile duct, and/or gallbladder illness” that were linked to eating one frozen lentil and leek crumble product.

According to that page, the company voluntarily began a recall of the product on June 17, 2022, “in response to consumer complaints submitted to the company.” The U.S. Food and Drug Administration, for its part, responded to reports and complaints sent directly to the agency: “the U.S. Food and Drug Administration has initiated an investigation, including an inspection and sample collection in an effort to determine the cause of illnesses.”

The U.S. Food and Drug Administration updated the page on June 30, July 14, July 28, August 25, September 15 and October 21, 2022. The page states that its content is current as of October 25, 2022. This was an investigation and a consumer advisory, not a rule: the U.S. Food and Drug Administration documents for it are web pages, not Federal Register notices, and there is no rulemaking docket.

Back to Table of Contents

2. The Recall and Where the Product Went

The U.S. Food and Drug Administration’s June 30, 2022 update gives the distribution figures. 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,” and through retail sales at one store in Chicago, Illinois, and a “pop-up” store in Los Angeles, California. The same update adds that samples were also given to a small number of consumers.

The U.S. Food and Drug Administration page reports that all lot codes of the product were affected and that, at the time, no other products from the company were part of the recall. The June 30 update says the company emailed consumers who had been shipped the product, as well as other consumers for whom it had contact information, and that consumers were issued a credit for the recalled product. The case table lists the product’s distribution as nationwide.

A voluntary recall is one the company itself starts; the U.S. Food and Drug Administration’s page links the company’s recall announcement and reports the agency’s own investigation alongside it.

Back to Table of Contents

3. The Illnesses Described in the Reports

The early U.S. Food and Drug Administration updates (June 30 through September 15, 2022) described complaints of “gastrointestinal illness and abnormal liver function that may be attributable to eating” the product. The final update of October 21, 2022 described them as “gastrointestinal illness and liver, bile duct, and/or gallbladder illness.”

The U.S. Food and Drug Administration page lists these symptoms in people who became ill after eating the product:

The bile ducts are the tubes that carry bile from the liver to the gallbladder and intestine. Several of the listed symptoms, such as jaundice, dark urine and pale stool, are signs that the liver or the bile system is affected; the site’s Liver Disease and Gallbladder Disease pages describe those organs.

Back to Table of Contents

4. How the Number of Reports Grew

Each U.S. Food and Drug Administration update gave the number of reports and complaints the agency had received about the product:

The final case table on the U.S. Food and Drug Administration page reads:

The U.S. Food and Drug Administration marks the illness, hospitalization and onset figures as an “Estimate based on Consumer Complaint and CAERs reports received by the U.S. Food and Drug Administration.” In other words, they count reports sent to the agency, not laboratory-confirmed cases.

Back to Table of Contents

5. How the U.S. Food and Drug Administration Investigated

The U.S. Food and Drug Administration page names two sources of the reports that started the agency’s work: its adverse event reporting system, known as CAERS, and consumer complaints submitted to the U.S. Food and Drug Administration. An adverse event report is a report that someone became ill or was harmed after using a product; it records what was reported, and on its own does not establish that the product caused the illness.

In response, the U.S. Food and Drug Administration said it began an investigation that included an inspection (a visit to examine how the product was made) and sample collection (taking product for laboratory testing), “in an effort to determine the cause of illnesses.” The page names the Centers for Disease Control and Prevention (U.S. Centers for Disease Control and Prevention) and state and local partners as part of the investigation.

By the October 21, 2022 update the response had moved out of the U.S. Food and Drug Administration’s outbreak team. The page states that the incident was “no longer being handled by U.S. Food and Drug Administration’s Coordinated Outbreak Response & Evaluation (CORE) Network,” but that “U.S. Food and Drug Administration’s research and investigation to evaluate which components of this product may have caused these illnesses is ongoing and more information will be provided as it becomes available.” No later update appears on the page, whose content is marked current as of October 25, 2022.

Back to Table of Contents

6. What the U.S. Food and Drug Administration Told Consumers and Clinicians

The U.S. Food and Drug Administration page carried an advisory in the agency’s own words. Under the heading “Recommendation,” it states that consumers “should not eat, sell, or serve recalled products” and that consumers who may still have the recalled product in their freezers “should throw it away.”

For people with symptoms after eating the product, the U.S. Food and Drug Administration page tells them to “consult with your healthcare provider” and to let the provider know they had recently eaten the recalled product. It added that “Healthcare providers should report these illnesses to their health department.” The page also points readers to the U.S. Food and Drug Administration’s channel for reporting a complaint or adverse event. These are the U.S. Food and Drug Administration’s statements; questions about any illness belong with a clinician.

Back to Table of Contents

7. The 2024 Tara Flour Determination

On May 15, 2024, the U.S. Food and Drug Administration published a constituent update, “U.S. Food and Drug Administration Update on the Post-market Assessment of Tara Flour.” It reports that the U.S. Food and Drug Administration posted its determination that “tara flour in human food does not meet the Generally Recognized As Safe (or generally recognized as safe, GRAS) standard and is an unapproved food additive.” The U.S. Food and Drug Administration’s public inventory of post-market determinations lists the scientific memorandum on tara flour with the date April 10, 2024.

What generally recognized as safe means. The constituent update explains that under the Federal Food, Drug, and Cosmetic Act, any ingredient used in food must be authorized by the U.S. Food and Drug Administration as a food additive unless its use is “Generally Recognized As Safe or generally recognized as safe by qualified experts” or meets a listed exception. It adds: “An unapproved food additive is deemed to be unsafe under the FD&C Act,” and “Food that is, or contains, an unsafe food additive is considered adulterated.”

Why tara flour did not qualify. The U.S. Food and Drug Administration wrote that its evaluation “revealed that there is not enough data on the use of tara flour in food, or a history of its safe use, to consider it generally recognized as safe,” and that no food additive regulation authorizes its use in food.

The link to the 2022 illnesses. The update states that in 2022 the company used tara flour in the lentil and leek crumble product, which “was associated with roughly 400 adverse event reports.” It says the firm recalled the product and carried out its own root cause analysis, “during which they identified tara flour as a possible contributor to the illnesses.” The U.S. Food and Drug Administration then states: “To date, the U.S. Food and Drug Administration has found no evidence that tara flour caused the outbreak; however, it did prompt the agency to evaluate the regulatory status of this food ingredient.”

Monitoring. The U.S. Food and Drug Administration wrote that it was not aware of tara flour being developed domestically as a food ingredient or of products containing it being made in the United States, that it had set up screening at ports of entry for tara flour in imported food or imported in bulk, and that it had “not detected any recent shipments of tara flour in imported products” as of May 15, 2024. Manufacturers considering tara flour, the update says, are responsible for making sure its use is safe and lawful.

Back to Table of Contents

8. What the Investigation Does Not Show

Back to Table of Contents

9. Dates and Status as of October 18, 2026

Status as of October 18, 2026: investigation concluded as an outbreak response, cause not determined; tara flour in human food has been treated by the U.S. Food and Drug Administration as an unapproved food additive since May 15, 2024. The U.S. Food and Drug Administration investigation page has not been updated since October 2022, and the tara flour constituent update, current as of May 15, 2024, still states that the U.S. Food and Drug Administration has found no evidence that tara flour caused the outbreak.

Back to Table of Contents

10. How It Fits Other U.S. Food and Drug Administration Food Actions

The tara flour determination is one entry in the U.S. Food and Drug Administration’s public inventory of post-market determinations that the use of a substance is not generally recognized as safe. The U.S. Food and Drug Administration’s 2024 constituent update describes it as part of the agency’s approach to food chemical safety and to greater transparency about its assessment of ingredients in the food supply. The site’s page on the U.S. Food and Drug Administration’s 2025 moves on self-affirmed generally recognized as safe and chemical reviews reports how that work developed. On August 11, 2026, the U.S. Food and Drug Administration published a proposed rule that would require generally recognized as safe notices to be submitted for food substances said to be generally recognized as safe (91 FR 51834; Docket No. FDA-2025-N-3262; comments due December 9, 2026), reported on the site’s generally recognized as safe mandatory notification proposal page.

Other 2022 U.S. Food and Drug Administration food actions are reported on their own pages: the infant formula recall and plant shutdown, the draft action levels for lead in juice, the phthalates food-contact revocation and the food traceability final rule.

A Federal Register docket is the public file for a rulemaking, where its documents and public comments are kept; the 2022 lentil crumble investigation had none, while the 2026 generally recognized as safe proposal has one.

Back to Table of Contents

11. Primary Documents

  1. U.S. Food and Drug Administration. Investigation of Adverse Event Reports (June 2022), frozen lentil and leek crumble product. Outbreak investigation page with updates of June 30, July 14, July 28, August 25, September 15 and October 21, 2022; content current as of October 25, 2022. No Federal Register citation or docket — fda.gov investigation page
  2. U.S. Food and Drug Administration. U.S. Food and Drug Administration Update on the Post-market Assessment of Tara Flour. Constituent Update, May 15, 2024. No Federal Register citation or docket — fda.gov constituent update
  3. U.S. Food and Drug Administration. Post-market Determinations that the Use of a Substance is Not generally recognized as safe. Public inventory listing the scientific memorandum on tara flour (April 10, 2024); content current as of May 8, 2025 — fda.gov not-GRAS inventory
  4. Food and Drug Administration, U.S. Department of Health and Human Services (HHS) (2026). Substances Generally Recognized as Safe. Proposed rule. Federal Register 91 FR 51834, August 11, 2026. Docket No. FDA-2025-N-3262 — FR Doc. 2026-16296

Back to Table of Contents

Key Research Papers

  1. Firestone MJ, Hedberg CW (2025). Unexplained Illnesses Associated With a Subscription Meal Service, 2022. Journal of Food Protection 88(1):100412 — PubMed PMID: 39577807
  2. Choi G, Ahmad J, Navarro V, Thung S, Khan I, Avula B, Barnhart H, Stolz A; Drug-Induced Liver Injury Network (2024). Characterisation of an outbreak of acute liver injury after ingestion of plant-based food supplement. Alimentary Pharmacology & Therapeutics 60(4):479-483 — PubMed PMID: 38874448
  3. Chan SE, Smith CA (2023). A food product as a potential serious cause of liver injury. Clinical Toxicology 61(8):616-619 — PubMed PMID: 37706365
  4. Fierro O, Siano F, Bianco M, Vasca E, Picariello G (2024). Comprehensive molecular level characterization of protein- and polyphenol-rich tara (Caesalpinia spinosa) seed germ flour suggests novel hypothesis about possible accidental hazards. Food Research International 181:114119 — PubMed PMID: 38448102
  5. Avula B, Katragunta K, Parveen I, Tatapudi KK, Chittiboyina AG, Wang YH, Khan IA (2025). Comprehensive Profiling of Free Proteinogenic and Non-Proteinogenic Amino Acids in Common Legumes Using LC-QToF: Targeted and Non-Targeted Approaches. Foods 14(4):611 — PubMed PMID: 40002056

The first paper is an epidemiologic analysis of 338 people who reported illness, using case data the authors obtained from a law firm; its authors write that the pattern of illness “suggests that tara flour was likely the source of illness, although a specific etiology remains unknown.” The second summarizes 17 patients with liver injury enrolled by the U.S. Drug-Induced Liver Injury Network after eating the product: 24% were hospitalized, with no deaths or liver transplants. The third describes two hospital cases of acute liver injury after a smoothie product that contained tara flour. The fourth analyzes the composition of tara seed germ flour and raises alternative hypotheses about possible hazards. The fifth develops a laboratory method for measuring unusual amino acids in legumes, citing the tara flour episode as its motivation. These are the researchers’ findings and views; the U.S. Food and Drug Administration has stated that it found no evidence that tara flour caused the outbreak.

PubMed Topic Searches

  1. PubMed: tara flour
  2. PubMed: baikiain
  3. PubMed: food products and acute liver injury outbreaks

Back to Table of Contents

Connections

Back to Table of Contents