CLASS III Food recall · Reported 22 May 2019 · FDA Enforcement Report

Item FG 10079, Barleans, Flax Oil, 100 Softgels per bottle recalled

Barlean's is recalling Item FG 10079, Barleans, Flax Oil, 100 Softgels per bottle, distributed nationwide in the US. The recall was initiated on 6 May 2019 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesBest By of January 2022 and earlier

Quantity recalled667 bottles (Item FG 10079); 1058 bottles (FG 10081); Firm did not provide for FG 7000

Do not eat it. Return it to the store for a refund or throw it away. If you have symptoms after eating it, contact a doctor.

Recall details

Recall number: F-1371-2019
FDA event ID: 82565
Recalling firm: Barlean's, Ferndale, WA
Classification: Class III
Status: Terminated
Recall initiated: 6 May 2019
FDA classified: 16 May 2019
Reported: 22 May 2019
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Undeclared Sulfites
Product category: Dietary Supplements

Timeline

6 May 2019	Recall initiated by company
16 May 2019	Classified by FDA	+10 days
22 May 2019	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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 as listed by the FDA

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.

Where it was distributed

nationwide

Nationwide

Questions about this recall

Why was it recalled?

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

Which lots are affected?

Best By of January 2022 and earlier

Where was it sold?

nationwide

What should I do if I have it?

Do not eat it. Return it to the store for a refund or throw it away. If you have symptoms after eating it, contact a doctor.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

11 other products · FDA event 82565

Reported	Class	Recall	Company	Reason	Where
22 May 2019	CLASS III	Item FG 10146, Barlean s, Essential Woman, 120 count Softgels recalled	Barlean's	Undeclared Sulfites	Nationwide
22 May 2019	CLASS III	Item FG 10084, Barlean s, Ultra EPA Fish Oil 1250 mg Omega recalled	Barlean's	Undeclared Sulfites	Nationwide
22 May 2019	CLASS III	Item FG 10083, Barlean's, Ultra DHA Fish Oil Omega-3, Lemonade recalled	Barlean's	Undeclared Sulfites	Nationwide
22 May 2019	CLASS III	Item FG 10037, Barlean s Cod Liver Oil Omega 3 EPA/DHA with Added recalled	Barlean's	Undeclared Sulfites	Nationwide
22 May 2019	CLASS III	Item FG 10149, Barlean s, Omega Man, 120 Softgels per bottle recalled	Barlean's	Undeclared Sulfites	Nationwide
22 May 2019	CLASS III	Item FG 10085, Barleans, Ultra Epa-dha Fish Oil 1,300 mg Omega recalled	Barlean's	Undeclared Sulfites	Nationwide
22 May 2019	CLASS III	Item FG 10106, Barlean s, Olive Leaf Complex recalled	Barlean's	Undeclared Sulfites	Nationwide
22 May 2019	CLASS III	Item FG 10190, Barleans Full Spectrum Hemp Extract, 60 Softgels recalled	Barlean's	Undeclared Sulfites	Nationwide
22 May 2019	CLASS III	Item FG 10089, Barlean s, Fish Oil Omega-3 EPA/DHA Orange recalled	Barlean's	Undeclared Sulfites	Nationwide
22 May 2019	CLASS III	Item FG 10191, Barlean s Ideal CBD Hemp Oil Softgel recalled	Barlean's	Undeclared Sulfites	Nationwide
22 May 2019	CLASS III	Item FG 10116, Barlean s, Master Blend Total Omega 3.6.9 Lemonade recalled	Barlean's	Undeclared Sulfites	Nationwide

More recalls from Barlean's

All 12

Reported	Class	Recall	Company	Reason	Where
22 May 2019Food	CLASS III	Item FG 10116, Barlean s, Master Blend Total Omega 3.6.9 Lemonade recalled	Barlean's	Undeclared Sulfites	Nationwide
22 May 2019Food	CLASS III	Item FG 10191, Barlean s Ideal CBD Hemp Oil Softgel recalled	Barlean's	Undeclared Sulfites	Nationwide
22 May 2019Food	CLASS III	Item FG 10089, Barlean s, Fish Oil Omega-3 EPA/DHA Orange recalled	Barlean's	Undeclared Sulfites	Nationwide
22 May 2019Food	CLASS III	Item FG 10190, Barleans Full Spectrum Hemp Extract, 60 Softgels recalled	Barlean's	Undeclared Sulfites	Nationwide
22 May 2019Food	CLASS III	Item FG 10106, Barlean s, Olive Leaf Complex recalled	Barlean's	Undeclared Sulfites	Nationwide

Other Dietary Supplements recalls

All 733

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21 Sep 2026Food	ANNOUNCED	Niwali Tejocote Capsules and Pieces recalled by Global MixNiwali	Global Mix	Foreign Material	Nationwide
2 Sep 2026Food	CLASS I	Addall XR Shot, liquid dietary supplement recalled by ZMB EnterprisesAddall XR	ZMB Enterprises	Hidden Drug Ingredients	CA
5 Aug 2026Food	CLASS II	Super Skin; Dietary Supplement;, 2 per day recalled by Mellish IslandMellish Island	Mellish Island	Other	Nationwide
29 Jul 2026Food	CLASS I	Modern Warrior Ready, Dietary Supplement recalledModern Warrior	Modern Warrior Life	Hidden Drug Ingredients	Nationwide
8 Jul 2026Food	CLASS II	Vista MAX; Dietary Supplement Serving Size recalled by Provision HealthVista MAX	Provision Health	Undeclared Allergens	CA