Organic IntegriPure Cold Milled Flaxseed, 50 lb Net Wt. and 2000 lb. totes
Healthy Food Ingredients, LLC recalled this product and the FDA reported the enforcement action on 5 February 2020 as Class II. The recall was initiated by the firm. Product is being recalled due to detection of an unapproved herbicide.
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
- Organic IntegriPure Cold Milled Flaxseed, 50 lb Net Wt. and 2000 lb. totes
- Reason for recall
- Product is being recalled due to detection of an unapproved herbicide.
- Recalling firm
- Healthy Food Ingredients, LLC
- Firm location
- Fargo, North Dakota, United States
- Classification
- Class II
- Status
- Terminated
- Recall number
- F-0571-2020
- Quantity
- 74,500 lbs. EXPANDED 02/2020 257,083 lbs.
- Distribution
- CA, CO, UT. EXPANDED February 2020: MN, MO, NC, NE, PA, RI, WI. International distribution to Canada
- Initiated
- 8 January 2020
- Reported by FDA
- 5 February 2020
- Terminated
- 6 July 2022
- Firm notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Product codes
- Lots: 4P194M-041119-103, 4P197M-270919-103, 4P197M-241019-EC. EXPANDED February 2020: Lot numbers: 4P152M-300719-103, 4P152M-300719-EC, 4P154M-120619-103, 4P154M-210619-101, 4P154M-EC, 4P155M-120619-103, 4P155M-120619-EC, 4P172M-300719-103, 4P172M-300719-EC, 4P179M-190819-103, 4P180M-311019-103, 4P190M-311219-103, 4P191M-170919-103, 4P191M-301219-EC, 4P203M-151019-101.
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 2.5 years, from 8 January 2020 to termination on 6 July 2022. 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 7 states, and the FDA published the enforcement report 4 weeks after the firm began the recall.
- Recalls of nuts or seeds run a median of 7 months, so this one was longer than usual for its category. Nuts and seeds carry both hazards at once: they are a major allergen in their own right, and as a low-moisture food they hold Salmonella for months without supporting its growth, which is why a nut butter recall can trace to a lot pressed a year earlier.
Named in the distribution pattern: California, Colorado, Missouri, North Carolina, Nebraska, Pennsylvania, Rhode Island. 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
Chemical contamination
A chemical contamination recall covers a substance that is harmful in food and was never meant to be there: a heavy metal, a cleaning chemical, a pesticide residue, or a natural toxin such as aflatoxin or histamine.
A preventive controls plan covers chemical 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 117.35(b)
- Substances used in cleaning and sanitizing: toxic materials stored, identified and used so they cannot contaminate food, food-contact surfaces or packaging.
- 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 117.130(b)(1)(ii)
- Hazard analysis: identifying the known or reasonably foreseeable chemical hazards, including radiological hazards, pesticide and drug residues, natural toxins and food decomposition.
Unapproved ingredients
An unapproved ingredient recall means a product contained a substance not permitted in food, most often an undisclosed pharmaceutical active found in a dietary supplement.
A preventive controls plan covers an unapproved ingredient 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 111
- Dietary supplement CGMP: the identity, purity, strength and composition specifications a supplement manufacturer sets and verifies for every component and finished batch.
- 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.
Filed under nuts and seeds. A product can sit in more than one.
Other nuts and seeds 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.
All 2020 recalls · All FDA food recall data
21 CFR 117.35(b) 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.