Sugar-free Mixed Berry Gummies Brand Name: Extract Labs Generic Name: Dietary Supplement Strength: 10mg CBD and 10mg D
Summary
The FDA issued a Class II for Sugar-free Mixed Berry Gummies Brand Name: Extract Labs Generic Name: Dietary S by Extract Labs, Inc.. Reason: Potential peanut protein cross-contact..
Details
Source
Food Recall
External ID
H-0621-2025
Action Date
2025-10-01
Status
Terminated
Category
food
Product Description
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
Lot/Code Info: Lot: 25E5082907A (we call this a batch ID) EXP: 07/2027 Printed on the bottom of the bottle
Quantity Affected: 2180 gummies (109/20 ct bottles)
Reason for Recall
Potential peanut protein cross-contact.
Distribution
Product distributed throughout the United States and Australia, Germany, United Kingdom, Malaysia, and New/Zealand.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-08-26
Company
Lafayette, CO
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 61 food recalls issued in the same week, part of 204 food-related FDA actions this month.
Extract Labs, Inc. has 4 FDA actions in our database, including 4 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Extract Labs, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Extract Labs, Inc. have FDA actions?
Extract Labs, Inc. has 4 FDA actions in our database, including 4 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "H-0621-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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