Expanded Recall: 50 lb Wondra Enriched Unmalted Flour Unit UPC 100-16000-54380 Code…
General Mills, Inc recalled this product and the FDA reported the enforcement action on 21 September 2016 as Class I. The recall was initiated by the firm. General Mills is recalling a number of products because of a multistate outbreak of E. coli O121 that may be potentially linked to Gold Medal flour, Wondra flour, and Signature Kitchens flour. To date, E. coli O121 has not been found in any General Mills flour products or in the flour manufacturing facility and the company has not been contacted directly by any consumer reporting confirmed illnesses related to these products.
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
- Expanded Recall: 50 lb Wondra Enriched Unmalted Flour Unit UPC 100-16000-54380 Code Dates/Production Dates 04NOV2015KC, 05NOV2015KC
- Reason for recall
- General Mills is recalling a number of products because of a multistate outbreak of E. coli O121 that may be potentially linked to Gold Medal flour, Wondra flour, and Signature Kitchens flour. To date, E. coli O121 has not been found in any General Mills flour products or in the flour manufacturing facility and the company has not been contacted directly by any consumer reporting confirmed illnesses related to these products.
- Recalling firm
- General Mills, Inc
- Firm location
- Minneapolis, Minnesota, United States
- Classification
- Class I
- Status
- Terminated
- Recall number
- F-2221-2016
- Quantity
- 614,478 for all products
- Distribution
- All states in US including PR, US Virgin Islands, Guam, Northern Mariana Islands except AK & SD. OUS: ARUBA, HONK KONG, CHINA , BAHAMAS, JAMAICA, BERMUDA, CURACAO, HAITI, THAILAND.
- Initiated
- 31 May 2016
- Reported by FDA
- 21 September 2016
- Terminated
- 30 March 2021
- Firm notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Product codes
- Expanded Recall: 04NOV2015KC, 05NOV2015KC
Reading this record
Five things about this record are not in the record itself, and each one changes how it should be read.
- Class I means the FDA judged a reasonable probability that the product would cause serious health consequences or death. 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 is one of 10 records covering the same recall event. The FDA opens one enforcement record per product code, so a recall of a product line appears here many times. Counting these records as 10 separate recalls, which almost every published figure does, overstates it by a factor of 10. Every product code in this event is listed together on the record that covers the whole recall, which is the page a search engine is pointed to for all 10 of them.
- The recall ran for 4.8 years, from 31 May 2016 to termination on 30 March 2021. 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 FDA published the enforcement report 4 months after the firm began the recall.
- Recalls of a grain, flour or pasta product run a median of 6 months, so this one was longer than usual 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.
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 General Mills, Inc
The FDA opens one enforcement record per product code, so several of these are frequently one recall event. 37 other records name this firm.
All 38 records for General Mills, Inc
All 2016 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 accessRecall 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.