The Recall Desk
HighFDA (Food)·F-1001-2023·Announced 2023-06-28

FDA Recalls Earth Kratom Red Maeng Da Capsules for Unapproved Additive

Fire Distributors Plus LLC is recalling Earth Kratom Red Maeng Da Kratom capsules because they contain kratom, an unapproved food additive. Approximately 31,600 pouches were distributed in the United States.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recalls involve significant quality and safety concerns. While no reported illnesses or injuries are documented, this recall concerns an unapproved food additive, constituting a regulatory violation where kratom's safety profile in this context is undefined.

Plain-English summary

Fire Distributors Plus LLC is recalling Earth Kratom Red Maeng Da Kratom 65-capsule pouches (UPC 212223242796) distributed under the FIRE WHOLESALE brand. Approximately 31,600 pouches were distributed in the United States.

The FDA has determined that the product contains kratom, an unapproved food additive. Kratom (Mitragyna speciosa leaf) is not approved for use as a food or food additive under FDA regulations.

The affected product contains kratom leaf, purified water, vegetable magnesium stearate, and gelatin capsules. U.S. distribution only; no foreign distribution has been identified.

The recalled product

Product
EARTH KRATOM RED MAENG DA KRATOM 65 CAPSULES (UPC: 212223242796) (100 UNITS/CASE). DISTRIBUTED BY FIRE WHOLESALE. Ingredients: Mitragyna speciosa leaf, purified water, vegetable magnesium stearate, and gelatin capsules.
Manufacturer
Fire Distributors Plus LLC
Category
Food
Hazard
  • unapproved-food-additive

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • None

Distribution

Distribution scope not specified by the agency.

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