Sugar-free Mixed Berry Gummies Brand Name: Extract Labs Generic Name: Dietary Supplement…
Extract Labs, Inc. recalled this product and the FDA reported the enforcement action on 1 October 2025 as Class II. The recall was initiated by the firm. Potential peanut protein cross-contact.
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
- Sugar-free Mixed Berry Gummies Brand Name: Extract Labs Generic Name: Dietary Supplement Strength: 10mg CBD and 10mg D9 THC per gummy Dosage: 1 gummy Form: Gummy Administration: Oral Intended use: Dietary Supplement Type of packaging: 225cc amber packer bottle with child-resistant cap and inner pressure seal Net wt: 3.53oz UPC: 850029647928 Firm name & address: Extract Labs, Inc., 1399 Horizon Ave, Lafayette, CO 80026
- UPC
- 850029647928
- Reason for recall
- Potential peanut protein cross-contact.
- Recalling firm
- Extract Labs, Inc.
- Firm location
- Lafayette, Colorado, United States
- Classification
- Class II
- Status
- Terminated
- Recall number
- H-0621-2025
- Quantity
- 2180 gummies (109/20 ct bottles)
- Distribution
- Product distributed throughout the United States and Australia, Germany, United Kingdom, Malaysia, and New/Zealand.
- Initiated
- 26 August 2025
- Reported by FDA
- 1 October 2025
- Terminated
- 30 October 2025
- Firm notified by
- Product codes
- Lot: 25E5082907A (we call this a batch ID) EXP: 07/2027 Printed on the bottom of the bottle
Reading this record
Five things about this record are not in the record itself, and each one changes how it should be read.
- Class II means the FDA judged a remote probability of serious harm, or a probability of temporary or medically reversible harm. 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 4 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 4 separate recalls, which almost every published figure does, overstates it by a factor of 4. 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 4 of them.
- The recall ran for 2 months, from 26 August 2025 to termination on 30 October 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 fresh produce run a median of 7 months, so this one was shorter than usual for its category. Fresh produce is the category where contamination arrives before the facility does: irrigation water, soil amendments and field workers are the routes, and nothing downstream of the farm is a kill step for a product eaten raw.
Filed under fresh produce, dietary supplements and snacks and confectionery. A product can sit in more than one.
Other fresh produce recalls
These are the closest records in the corpus: the same kind of food. Unlike the firm’s own records below, they come from different companies, which is what makes them a pattern rather than a history.
Other records from Extract Labs, Inc.
The FDA opens one enforcement record per product code, so several of these are frequently one recall event.
All 4 records for Extract Labs, Inc.
All 2025 recalls · All FDA food recall data
Behind every recall is a clause 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.