Class IITerminated · reported 2020-01-01

Wild Harvest Organic Unbleached All Purpose Flour, Net Wt 5 lb. (2.26 kg) in paper bags…

Ardent Mills LLC recalled this product and the FDA reported the enforcement action on 1 January 2020 as Class II. The recall was initiated by the firm. Wild Harvest Organic Unbleached All Purpose Flour in 5 lb. bags has the potential to be contaminated with E. coli (STEC).

The record

Every field below is published by the FDA in the openFDA food enforcement database. Check the FDA notice before acting on any recall: this page is a reading of the public record, not a substitute for it.

Product: Wild Harvest Organic Unbleached All Purpose Flour, Net Wt 5 lb. (2.26 kg) in paper bags, UPC 7 11535 50915 8, 8 bags per case.
UPC: 711535509158
Reason for recall: Wild Harvest Organic Unbleached All Purpose Flour in 5 lb. bags has the potential to be contaminated with E. coli (STEC).
Recalling firm: Ardent Mills LLC
Firm location: Commerce City, Colorado, United States
Classification: Class II
Status: Terminated
Recall number: F-0435-2020
Quantity: 8,160 bags/ 1020 cases
Distribution: 900 cases were distributed to 4 different UNFI warehouses located in WI, OR, PA, IL. UNFI further distributes the product. 120 cases were distributed to Ardent Mills in Ogden UT.
Initiated: 26 November 2019
Reported by FDA: 1 January 2020
Terminated: 1 July 2020
Firm notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Product codes: AA BEST IF USED BY 010820 CC, UPC: 7 11535 50915 8, Mfg (internal) lot code: 481890

Reading this record

Five things about this record are not in the record itself, and each one changes how it should be read.

Class II means the FDA judged a remote probability of serious harm, or a probability of temporary or medically reversible harm. The class is assigned by an agency health hazard evaluation under 21 CFR 7.41, not by the firm.
The firm started this recall itself. Most FDA food recalls are voluntary, and a recall is a food safety plan working rather than failing. The circumstances in which the agency asks for one instead are set out in 21 CFR 7.45.
This record is the only one the FDA opened for its recall event, so it covers a single product code.
The recall ran for 7 months, from 26 November 2019 to termination on 1 July 2020. Termination means the agency judged that all reasonable effort had been made, under 21 CFR 7.55, and it says nothing about whether product remained in circulation.
The distribution pattern names 2 states, and the FDA published the enforcement report 5 weeks after the firm began the recall.
Recalls of a grain, flour or pasta product run a median of 6 months, so this one was about typical for its category. Flour is a raw agricultural product that consumers treat as though it were cooked, which is the whole reason raw flour recalls exist: nothing in milling is a kill step, and the hazard only appears when somebody eats the dough.

Named in the distribution pattern: Oregon, Pennsylvania. Those pages count recalls by where the RECALLING FIRM sits, which is a different question from where this product went.

What this recall was for

E. coli

Shiga toxin-producing E. coli recalls concentrate in foods eaten raw or lightly cooked, where no step in the process is hot enough or long enough to be a kill step.

A preventive controls plan covers E. coli contamination under the clauses below. This is where the control belongs, not a finding against any firm named on this page: a recall record states a reason, and most of these recalls were initiated by the firm itself.

21 CFR 117.135(c)(1): Process controls: the controls that apply a treatment, such as a validated kill step, at the point where it reduces the hazard to a safe level.
21 CFR 117 subpart G: Supply-chain programme: the approval and verification a receiving facility runs on a supplier when the hazard is controlled before the ingredient arrives.
21 CFR 120: Juice HACCP: the hazard analysis and critical control point system required for juice processors, including a treatment achieving a 5-log pathogen reduction.

Filed under grains, flour and pasta. A product can sit in more than one.

Other grains, flour and pasta recalls for the same reason

These are the closest records in the corpus: the same kind of food, recalled for a hazard this record also names. Unlike the firm’s own records below, they come from different companies, which is what makes them a pattern rather than a history.

Reported	Product	Firm	Reason	Class
2020-02-19	King Arthur All Purpose Flour 25# bags	Adm Milling	E.coli O26	Class I
2020-02-19	H&R Flour, UNBL, EN, MT / Product Code 706220 in 50# bags	Adm Milling	E.coli O26	Class I
2020-02-19	Potentate flour / Prod Code: 802217 in 50# bags	Adm Milling	E.coli O26	Class I
2020-02-19	Bulk flour	Adm Milling	E.coli O26	Class I
2020-02-19	Commander Flour, Product Code 704220 in 50 lbs bags	Adm Milling	E.coli O26	Class I
2020-02-19	Bakers Corner All Purpose Flour in 5 lb. bags	Adm Milling	E.coli O26	Class I
2020-02-19	PB 25 LBS All Purpose Flour Product Code 806326	Adm Milling	E.coli O26	Class I
2020-02-19	Best Baker's flour 50 lbs bags	Adm Milling	E.coli O26	Class I

Other records from Ardent Mills LLC

The FDA opens one enforcement record per product code, so several of these are frequently one recall event. 9 other records name this firm.

Reported	Product	Firm	Reason	Class
2022-06-08	BBU Fine Whole Wheat Flour Bulk-AA-50251, Bulk Tanker; SG Whole Wheat Fine Flour 2,000 lb. Tote-AA Storage instructions - Any product made from raw agricultural commodities, such as wheat, rye and other grains, may be subject to infestation if not properly inspected when received, handled, and stored. To reduce the risk of infestation, customer should ensure it has proper goods receiving inspection procedures, and should store the product in a clean, dry area that is well ventilated	Ardent Mills, LLC	Potential to contain small pieces of stainless steel from a piece of milling equipment which was discovered during an investigative inspection of our system.	Class II
2022-03-09	Ardent Mills Hotel and Restaurant All Purpose Flour - AA, 50 lb. (22.68kg) bag, UPC 6 78008 00053 9, Ardent Mills, Denver, CO 80202. Milled in Alton, IL.	Ardent Mills, LLC	Raw, untreated flour tested positive for Salmonella.	Class II
2020-02-26	Kroger Unbleached All Purpose Enriched Flour, 5 lb. bag. Bar code: 011110861660	Ardent Mills LLC	Product may be contaminated with Salmonella.	Class II
2019-02-27	MEMBERS MARK SELF RISE FLR 25LB	Ardent Mills, LLC	Ardent Mills is voluntarily recalling certain lots of Self-Rising Flour because it has the potential to be contaminated with Salmonella.	Class II
2019-02-27	WESTCREEK H&R SELF RISE AP FLR 25LB and 50LB	Ardent Mills, LLC	Ardent Mills is voluntarily recalling certain lots of Self-Rising Flour because it has the potential to be contaminated with Salmonella.	Class II
2019-02-27	HILLTOP HEARTH SELF RISE FLR 25LB and 50LB	Ardent Mills, LLC	Ardent Mills is voluntarily recalling certain lots of Self-Rising Flour because it has the potential to be contaminated with Salmonella.	Class II
2019-02-27	ARDENT H&R SR FLR, 25LB, 50 LB, and 25LB (PC)-309951, packaged in paper bags, Store at Ambient Temperature	Ardent Mills, LLC	Ardent Mills is voluntarily recalling certain lots of Self-Rising Flour because it has the potential to be contaminated with Salmonella.	Class II
2018-10-24	Safeguard Soft Flr (GIV) packaged in 50 lb bags	Ardent Mills, LLC	Flour tested positive for Salmonella by customer.	Class II
2017-07-19	PRIMO MOLINO ITALIAN STYLE ENRICHED FLOUR, 50 lb, Packaged in paper bags, Store at Ambient Temperature, produced on 10/31/16, Product code 15031	Ardent Mills, LLC	Primo Molino Italian Style Flour may be contaminated with E. coli O121.	Class I

All 10 records for Ardent Mills, LLC

All 2020 recalls · All FDA food recall data

21 CFR 117.135(c)(1) is the clause behind this recall, and it is one somebody has to produce evidence for at their next audit. Krolda maps supplier documents to the clause they satisfy in FSSC 22000, IFS Food and 21 CFR 117, and routes the corrective action when the evidence is missing.

Early access

Recall records come from the openFDA food enforcement API, published by the U.S. Food and Drug Administration in the public domain. Krolda adds the hazard classification and the clause mapping; neither is an FDA determination. Always check the FDA notice before acting on a recall.