United States
TerminatedClass II
The firm's dietary supplement products contain kratom (Mitragyna speciosa), a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury;
| Product description | UPC | Quantity | Lot / code information |
|---|---|---|---|
| Kratom powder labeled in the following ways 1) Enhance Your Life, Kratom Essence Maeng Da Mitragyna speciosa, 150 gras; 2) Bali Kratom, 15 g Powdered; 3) Bali Kratom, 30 g Powdered; 4) Bali Kratom, 60 g Powdered; 5) Bali Kratom, 120 g Powdered; 6) Botany Bay, 1 oz | Not published in this source record | All lot codes with expiration dates after 1/31/2018 |
This recall shares FDA event ID 79212 with 1 other product entry in Public Health Trace.
FDA Recall United States TerminatedTerminated: September 14, 2018Historical recordClass II
Responsible company: Divinity Product Distribution LLC
FDA Recall United States TerminatedTerminated: September 14, 2018Historical recordClass II
A map highlighting the states named in the source's distribution description.
Shading reflects state-level totals only, as published by the source. It does not imply county-level or point-level precision.
| State | Distributed |
|---|---|
| Alaska | 1 |
| Alabama | 1 |
| Arkansas | 1 |
| Arizona | 1 |
| California | 1 |
| Colorado | 1 |
| Connecticut | 1 |
| District of Columbia | 1 |
| Delaware | 1 |
| Florida | 1 |
| Georgia | 1 |
| Idaho | 1 |
| Illinois | 1 |
| Indiana | 1 |
| Kansas | 1 |
| Kentucky | 1 |
| Louisiana | 1 |
| Massachusetts | 1 |
| Maryland | 1 |
| Maine | 1 |
| Michigan | 1 |
| Minnesota | 1 |
| Missouri | 1 |
| Mississippi | 1 |
| North Carolina | 1 |
| North Dakota | 1 |
| New Hampshire | 1 |
| New Jersey | 1 |
| New Mexico | 1 |
| Nevada | 1 |
| New York | 1 |
| Ohio | 1 |
| Oklahoma | 1 |
| Oregon | 1 |
| Pennsylvania | 1 |
| Rhode Island | 1 |
| South Carolina | 1 |
| Tennessee | 1 |
| Texas | 1 |
| Utah | 1 |
| Virginia | 1 |
| Washington | 1 |
| Wisconsin | 1 |
| West Virginia | 1 |
States shown are extracted from the source's free-text distribution description above; a narrative description (e.g. "distributed nationwide") may not list individual states to extract.
View FDA enforcement record -- the specific openFDA record this summary was built from.
This record comes from FDA's Enforcement Report database. Not every Enforcement Report record has a separate FDA.gov recall-announcement page.
FDA Enforcement Reports -- FDA's general, official recall and enforcement information. See FDA Enforcement Reports versus recall announcements for how that database differs from a press-release-style announcement.
New to reading a recall record? See how to read an FDA recall record and what recall statuses mean.
View raw source data -- the machine-readable record this page's information was built from.
Retrieved by Public Health Trace:
FDA classifies this recall as Class II. See how to read an FDA recall record (linked above) for what each classification level means.
According to FDA, this recall's status is "Terminated." Always confirm the current status using the source links below, since status can change after Public Health Trace last retrieved this record.
Follow the responsible agency's published instructions, linked below -- recall guidance is set by that agency, not by Public Health Trace.
Public Health Trace does not provide medical advice -- review the linked official source below for current, authoritative information.
This record is preserved as published by FDA, as of September 14, 2018.
Status as reported: Terminated.
This page does not imply a current danger or a current consumer instruction -- review the official source for the most current information.
This summary is based on the official source record referenced above. Public Health Trace does not state that any company or product is unsafe beyond what the official source has published. Read the full medical disclaimer.
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