2nd EXPANSION 5/31/2016 Product shipped OUS only
Food recall F-2264-2016. Published in FDA’s Enforcement Report on Sep 21, 2016.
- FDA Class I
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Sep 21, 2016. Copied from openFDA on Nov 4, 2026.
- Class I FDA’s most serious class (needs attention)
- Terminated its status, in FDA’s file
- 31 states named in where it went
- 2nd EXPANSION 5/31/2016 8,266,463 lbs. total how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class I, the most serious of FDA’s three classes.
“Dangerous or defective products that predictably could cause serious health problems or death. Examples include: food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve.”
openFDA, in plain words, its enforcement report fields.
“Class I is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.”
FDA’s rule, 21 CFR 7.3(m)(1), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
SunOpta is recalling sunflower kernel products that have the potential to be contaminated with Listeria monocytogenes. EXPANDED 5/18/2016 SunOpta expanded their recall of roasted sunflower kernel products to include the production dates of February 20 - April 26, 2016 due to potential Listeria monocytogenes contamination. 2nd EXPANSION 5/31/2016 SunOpta expanded their recall to include product produced at their Crookston, MN facility, still within expiry, to include the production dates of May 31, 2015 thru January 31, 2016
FDA, Food recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Which ones are recalled?
2nd EXPANSION 5/31/2016 Product shipped OUS only. Chili Limon Sunflower Kernel. 5 kg / 11 lb. box. Product of USA, Manufactured by SunOpta, Crookston, MN
2nd EXPANSION 5/31/2016 8,266,463 lbs. total, in FDA’s words.
FDA, Food recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Codes to check against yours
2nd EXPANSION 5/31/2016 PLot#: 8L5M16
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
AR, CA, CO, IL, IN, KY, MN, NC, ND, NH, OH, PA, SD, TX, WA, WI. EXPANDED 5/18/2016 Additional states: CT, FL, GA, IA, KS, LA, MA, MI, NJ, NY, OR 2nd EXPANSION 5/31/2016 Additional States: MD, MT, OK, VA. OUS to include: Canada, GUATEMALA, Great Britain, and Mexico.
The states and territories these words name
31 states and territories.
Every one of them
- Arkansas
- California
- Colorado
- Connecticut
- Florida
- Georgia
- Iowa
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Michigan
- Minnesota
- Montana
- North Carolina
- North Dakota
- New Hampshire
- New Jersey
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- South Dakota
- Texas
- Virginia
- Washington
- Wisconsin
The words say it went outside the United States too.
FDA, Food recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on May 2, 2016.
- FDA classified it on Sep 15, 2016.
- FDA’s Enforcement Report published it on Sep 21, 2016.
- FDA terminated it on Oct 30, 2026.
FDA, Food recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Who is recalling it?
- SunOpta Food and Grain, Inc., of Crookston, MN.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit.
FDA, Food recall enforcement reports. Released Nov 3, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- Meat, poultry and egg products are recalled by USDA’s Food Safety and Inspection Service, not FDA, and its recalls aren’t here yet: see fsis.usda.gov.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Food recall enforcement reports.
Released Nov 3, 2026 and checked Nov 4, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Nov 4, 2026.