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Divinity Product Distribution LLC Recall: 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;

United States

TerminatedClass II

Company
Divinity Product Distribution LLC
Product
Kratom powder labeled in the following ways 1) Enhance Your…
Recall date
February 9, 2018
Terminated
September 14, 2018
Source
FDA

Reason for recall

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;

  1. - Recall initiated
  2. - Reported by source
  3. - Recall terminated
Recalled products
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

Distribution

  • Product distributed to the following US states and countries: AK
  • AL
  • AR
  • Austria
  • AZ
  • CA
  • Canada
  • CO
  • CT
  • DC
  • DE
  • FL
  • GA
  • ID
  • IL
  • IN
  • KS
  • KY
  • LA
  • MA
  • MD
  • ME
  • MI
  • MN
  • MO
  • MS
  • NC
  • ND
  • NH
  • NJ
  • NM
  • NV
  • NY
  • OH
  • OK
  • OR
  • PA
  • RI
  • SC
  • TN
  • TX
  • United Kingdom
  • UT
  • VA
  • WA
  • WI
  • and WV

Official source record

Agency
FDA
Dataset
FDA Food Enforcement (Recalls)
Recall number
F-1021-2018
Event ID
79212
Status
Terminated
Classification
Class II
Company
Divinity Product Distribution LLC
Product description
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
Quantity
Reason
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;
Recall initiation date
February 9, 2018
Report date
April 25, 2018
Classification date
Not published in this source record
Termination date
September 14, 2018
Distribution pattern
Product distributed to the following US states and countries: AK, AL, AR, Austria, AZ, CA, Canada, CO, CT, DC, DE, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, United Kingdom, UT, VA, WA, WI, and WV
UPC, lot, and code information
All lot codes with expiration dates after 1/31/2018
Voluntary or mandated
Voluntary: Firm initiated
Initial notification method
Telephone
Source last updated
Not tracked separately from the Public Health Trace retrieval date below
Public Health Trace retrieval date

Other products recalled under this same event

This recall shares FDA event ID 79212 with 1 other product entry in Public Health Trace.

FDA Recall United States Terminated Historical recordClass II

Divinity Product Distribution LLC

Product
Kratom capsules labeled in the following ways: 1) Divinity K…
Published
April 25, 2018
Distribution
Product distributed to the following US…

View recall →

Responsible company: Divinity Product Distribution LLC

Other recalls from Divinity Product Distribution LLC

FDA Recall United States Terminated Historical recordClass II

Divinity Product Distribution LLC

Product
Kratom capsules labeled in the following ways: 1) Divinity K…
Published
April 25, 2018
Distribution
Product distributed to the following US…

View recall →

Distribution map

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.

Distribution map
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.

Where this information comes from

View FDA enforcement record -- the specific openFDA record this summary was built from.

No separate FDA public notice was found for this enforcement record. The information below comes from FDA's Recall Enterprise System through openFDA.

FDA Enforcement Reports -- FDA's general, official recall and enforcement information.

Technical source data

View raw source data -- the machine-readable record this page's information was built from.

Retrieved by Public Health Trace:

Frequently asked questions

What does a Class II mean?

A situation in which use of or exposure to a product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote.

Is this recall still active?

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.

What should I do if I have this product?

Follow the instructions published by the responsible agency (see the source links below) -- recall guidance (e.g. dispose of the product, return it for a refund, or check for a specific lot number) varies by recall and is set by that agency, not by Public Health Trace.

Where can I find more official information?

The source links below, published by FDA, are the authoritative record for this recall, including any updates issued after this summary was retrieved.

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.