Severity
Moderate
FDA Food recall · Reported April 25, 2018
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…
The recall
Divinity Product Distribution LLC issued this moderate-severity FDA Food recall — The firm's dietary supplement products contain kratom (Mitragyna speciosa), a new dietary ingredient for whic….
Sourced from official FDA Food enforcement records. Verify recall #F-1021-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Food action (record #F-1021-2018) was formally reported on April 25, 2018, with the manufacturer initiating the action on February 9, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Divinity Product Distribution LLC is listed as the recalling firm, operating out of Grain Valley, MO. The number of affected units is not disclosed in the agency filing, which is common for drug and food recalls where lot-level tracking supersedes unit counts.
The documented reason for this recall is: 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 sign… Distribution data in the federal record shows the product reached: 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, …. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 5 from FDA Food — clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category — 711 dietary supplements recalls on record
Of 100,165 recalls in the database, 23,668 are high severity, 72,097 moderate, and 4,400 low. This recall is classified moderate severity.
Severity
Moderate
Affected scope
Unknown
Related Recalls
6
5 from same agency
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
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;
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | F-1021-2018 |
| Date reported | April 25, 2018 |
| Date initiated | February 9, 2018 |
| Recalling firm | Divinity Product Distribution LLC |
| Firm location | Grain Valley, MO |
| Affected scope | Not disclosed |
| 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, Unit… |
Profile values are sourced directly from the official FDA Food enforcement record. Source: U.S. Food and Drug Administration.
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Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Food, reported April 25, 2018.
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Read our methodology — how this data is sourced, computed, and verified.
Source: Federal recall agencies (FDA, CPSC, NHTSA) Aggregated federal recall feeds Recall data normalized across FDA, CPSC and NHTSA feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type).