Class IF-2265-2016

Class I— FDA's most serious classification, issued when there is a reasonable probability that consumption of or exposure to the product will cause serious adverse health consequences or death.

Product

2nd EXPANSION 5/31/2016 Product shipped OUS only. Light Salt Sunflower Kernel, 5 kg / 11 lb. box. Product of USA, Manufactured by SunOpta, Crookston, MN

Type: Food
Affected lot / code info: 2nd EXPANSION 5/31/2016 PLot#: 8L5M10
Quantity: 2nd EXPANSION 5/31/2016 8,266,463 lbs. total

Why it was recalled

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

Recalling firm

Firm: SunOpta Food and Grain, Inc.
Notification channel: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Type: Voluntary: Firm initiated
Address: 1220 Sunflower St, N/A, Crookston, Minnesota 56716-2480

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2016-05-02
FDA classified: 2016-09-15
Posted by FDA: 2016-09-21
Status: Completed

Source: openFDA Food Enforcement endpoint. Recall record F-2265-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings.