LOW RISK Terminated F-1371-2019

Item FG 10079, Barleans, Flax Oil, 100 Softgels per bottle. UPC 7 05875 1007 6. Item FG 10081, Barleans, Lignan Flax Oil, 250 Softgels per bottle. UPC 7 05875 10008 3. Item FG 70000, Barlean's, Pure Flax Oil, 45 Softgels per bottle, label in English and Bulgarian. UPC 7 05875 14004 1.

Recalled by Barlean's Llc

Classification

Class III — Products that are unlikely to cause any adverse health reaction, but that violate FDA labeling or manufacturing laws.

Reason for Recall

Barlean's dietary supplement product is recalled due to undeclared Sulfites. Sulfite levels of finished goods does not exceed 10 ppm.

Product Details

Product Quantity
667 bottles (Item FG 10079); 1058 bottles (FG 10081); Firm did not provide for FG 7000
Product Type
Food
Code Info
Best By of January 2022 and earlier
Voluntary/Mandated
Voluntary: Firm initiated

Distribution & Geography

Distribution Pattern
nationwide
Company Location
Ferndale, WA, 98248-9518

Timeline

Report Date
05/22/2019
Recall Initiated
05/06/2019
Classification Date
05/16/2019
Termination Date
10/15/2020

Source: U.S. Food & Drug Administration (FDA) — FDA Recalls

Last updated: August 28, 2026

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