Mai Tai 20mg Gummies Brand Name: None - unlabeled bulk (private-label consignee) Generic Name: Dietary Supplement Stre
Summary
The FDA issued a Class II for Mai Tai 20mg Gummies Brand Name: None - unlabeled bulk (private-label consignee) by Extract Labs, Inc.. Reason: Potential peanut protein cross-contact..
Details
Source
Food Recall
External ID
H-0624-2025
Action Date
2025-10-01
Status
Terminated
Category
food
Product Description
Mai Tai 20mg Gummies Brand Name: None - unlabeled bulk (private-label consignee) Generic Name: Dietary Supplement Strength: 20mg CBD and 20mg D9 THC per gummy Dosage: Not declared at bulk stage (consignee determines serving size) Form: Gummy Administration: Oral Intended use: Dietary supplement for further packaging/labeling by consignee Type of packaging: Shipped in poly gusset bags, inside corrugated brown boxes, no consumer label applied. Net wt. Mai Tai: 24 bags x 5kg and 1 bag x 4kg UPC: N/A (unlabeled bulk) Firm name & address: None (no consumer label)
Lot/Code Info: Lot: 25JD042507A EXP: 07/2027 Printed on bulk bag identifier adhesive
Quantity Affected: 19,750 gummies
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-0624-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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