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FoodRecallWatch
Class III, Unlikely HarmfulF-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 on May 6, 2019

Reviewed by FoodRecallWatch Editorial Team · Updated

Recall Summary

Barlean's LLC recalled Item FG 10079, Barleans, Flax Oil, 100 Softgels per bottle. UPC 7 05875 1007 6. in a Class III action, the FDA tier used when a product is unlikely to cause adverse health effects, typically for labeling or minor regulatory issues on May 6, 2019.

The FDA listed the reason as an undeclared allergen: "Barlean's dietary supplement product is recalled due to undeclared Sulfites. Sulfite levels of finished goods does not exceed 10 ppm." Allergen mislabeling is the leading cause of U.S. food recalls, because a missing declaration can trigger a reaction in someone who reads the label and believes the product is safe.

Distribution was broad: the FDA record describes it as "nationwide," which places this among the wider-reach recalls on the site. Consumers across the affected area should check product on hand. The recalling firm is based in Ferndale, WA. The recall covers 667 bottles (Item FG 10079); 1058 bottles (FG 10081); Firm did not provide for FG 7000 of product. The FDA has Terminated this recall (first reported May 22, 2019), its final lifecycle state, indicating the agency considers the corrective action resolved. The historical record remains useful for tracking a brand's recall pattern over time.

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 Description

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.

Distribution

nationwide

What Should You Do?

  • 1.Check your kitchen for this product immediately.
  • 2.Do not consume the recalled product.
  • 3.Return the product to where you bought it for a full refund, or throw it away.
  • 4.If you have experienced any health issues, contact your healthcare provider.

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Terms Explained

Source: FDA Recalls, Market Withdrawals and Safety Alerts, 2026.