Extract Labs, Inc.
FDA Regulatory Profile
Extract Labs, Inc. has 4 FDA recalls, 1 inspection, 0 510(k) clearances and 0 compliance actions on record.
- Latest recall
- H-0624-2025 · Class II · Aug 26, 2025
- Latest inspection
- Aug 1, 2025 · VAI
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 4 | Nov 4, 2026 (checked Nov 8, 2026, unchanged) | File dated Nov 3, 2026 | Current |
|---|
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
|---|
| Inspections | 1 | Nov 10, 2026 | Newest record Nov 5, 2026 | Current |
|---|
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Recent Recalls
| Number | Class | Product | Date |
|---|
| H-0624-2025 | Class II | Mai Tai 20mg Gummies Brand Name: None - unlabeled bulk (private-label consignee) Generic Name… | Aug 26, 2025 |
| H-0621-2025 | Class II | Sugar-free Mixed Berry Gummies Brand Name: Extract Labs Generic Name: Dietary Supplement Strength… | Aug 26, 2025 |
| H-0622-2025 | Class II | Elderberry 20mg Gummies Brand Name: None - unlabeled bulk (private-label consignee) Generic Name… | Aug 26, 2025 |
| H-0623-2025 | Class II | Blue Razz 20mg Gummies Brand Name: None - unlabeled bulk (private-label consignee) Generic Name… | Aug 26, 2025 |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|
| Aug 1, 2025 | Lafayette, CO | Food/Cosmetics | Voluntary Action Indicated (VAI) | 3015536438 |
NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.
FDA-Inspected Facilities
| Facility | Location | Inspections | Latest |
|---|
| FEI 3015536438 | Lafayette, CO | 1 | Aug 1, 2025 |