Orgain 30g Plant Protein, Complete Protein Powder, 6g Prebiotic +Fiber, 9g EAAS+BCAAs…
Orgain, LLC recalled this product and the FDA reported the enforcement action on 22 January 2025 as Class I. The recall was initiated by the firm. Potential contamination of undeclared allergen peanuts
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.
- Product
- Orgain 30g Plant Protein, Complete Protein Powder, 6g Prebiotic +Fiber, 9g EAAS+BCAAs, 1gSugar, Chocolate Flavor; NET WT 32.1 OZ (2.01 LB) 912g; Nutritional Facts: Serving size 2 scoops, UPC: 8 51770 00760 3; QUESTIONS ABOUT ORGAIN PRODUCTS? 888-881-GAIN(4246) Lot# 4172-02-P
- UPC
- 851770007603
- Reason for recall
- Potential contamination of undeclared allergen peanuts
- Recalling firm
- Orgain, LLC
- Firm location
- Irvine, California, United States
- Classification
- Class I
- Status
- Terminated
- Recall number
- F-0386-2025
- Quantity
- 523 cases (12 count/case)
- Distribution
- Direct account list is still being compiled by firm. Customers include other than domestic. 6 total direct accounts( 4 distributors, 2 retail)
- Initiated
- 17 December 2024
- Reported by FDA
- 22 January 2025
- Terminated
- 20 May 2025
- Firm notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Product codes
- Expiration date: 06-20-26
Reading this record
Five things about this record are not in the record itself, and each one changes how it should be read.
- Class I means the FDA judged a reasonable probability that the product would cause serious health consequences or death. 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 record is the only one the FDA opened for its recall event, so it covers a single product code.
- The recall ran for 5 months, from 17 December 2024 to termination on 20 May 2025. 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 5 weeks after the firm began the recall.
- Recalls of a dietary supplement run a median of 15 months, so this one was shorter than usual 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.
What this recall was for
Undeclared allergens
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.
The allergens named in this record: peanuts.
Filed under dietary supplements and snacks and confectionery. A product can sit in more than one.
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.
All 2025 recalls · All FDA food recall data
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.
Early accessRecall 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.