Barlean's Llc recalled this product and the FDA reported the enforcement action on 22 May 2019 as Class III. The recall was initiated by the firm. Barlean's dietary supplement product is recalled due to undeclared Sulfites. Sulfite levels of finished goods does not exceed 10 ppm.
The record
Every field below is published by the FDA in the openFDA food enforcement database. Check the FDA notice before acting on any recall: this page is a reading of the public record, not a substitute for it.
1144 bottles (FG 10146) and 1913 bottles (FG 10147)
Distribution
nationwide
Initiated
6 May 2019
Reported by FDA
22 May 2019
Terminated
15 October 2020
Firm notified by
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Product codes
Best By of January 2022 and earlier
Reading this record
Five things about this record are not in the record itself, and each one changes how it should be read.
Class III means the FDA judged that the product was unlikely to cause harm but violated FDA labelling or manufacturing regulation. The class is assigned by an agency health hazard evaluation under 21 CFR 7.41, not by the firm.
The firm started this recall itself. Most FDA food recalls are voluntary, and a recall is a food safety plan working rather than failing. The circumstances in which the agency asks for one instead are set out in 21 CFR 7.45.
This is one of 12 records covering the same recall event. The FDA opens one enforcement record per product code, so a recall of a product line appears here many times. Counting these records as 12 separate recalls, which almost every published figure does, overstates it by a factor of 12. Every product code in this event is listed together on the record that covers the whole recall, which is the page a search engine is pointed to for all 12 of them.
The recall ran for 17 months, from 6 May 2019 to termination on 15 October 2020. Termination means the agency judged that all reasonable effort had been made, under 21 CFR 7.55, and it says nothing about whether product remained in circulation.
The FDA published the enforcement report 2 weeks after the firm began the recall.
Recalls of a dietary supplement run a median of 15 months, so this one was about typical for its category. Dietary supplements are regulated under their own good manufacturing practice rule, 21 CFR part 111, and they are the only food category where the dominant recall reason is an ingredient that was never declared because it is a pharmaceutical.
An undeclared allergen recall means a food contained one of the major allergens and the label did not say so, either because the wrong label was applied or because an ingredient carried an allergen nobody traced.
A preventive controls plan covers an undeclared allergen under the clauses below. This is where the control belongs, not a finding against any firm named on this page: a recall record states a reason, and most of these recalls were initiated by the firm itself.
21 CFR 117.135(c)(2)
Food allergen controls: the written preventive controls that keep an allergen out of a food it does not belong in, and that get the allergens present onto the label.
21 CFR 101.4
Ingredient declaration: every ingredient listed by its common name, in descending order of predominance, on the label of a packaged food.
21 CFR 117 subpart G
Supply-chain programme: the approval and verification a receiving facility runs on a supplier when the hazard is controlled before the ingredient arrives.
Other dietary supplements recalls for the same reason
These are the closest records in the corpus: the same kind of food, recalled for a hazard this record also names. Unlike the firm’s own records below, they come from different companies, which is what makes them a pattern rather than a history.
21 CFR 117.135(c)(2) is the clause behind this recall, and it is one somebody has to produce evidence for at their next audit. Krolda maps supplier documents to the clause they satisfy in FSSC 22000, IFS Food and 21 CFR 117, and routes the corrective action when the evidence is missing.
Recall records come from the openFDA food enforcement API, published by the U.S. Food and Drug Administration in the public domain. Krolda adds the hazard classification and the clause mapping; neither is an FDA determination. Always check the FDA notice before acting on a recall.
