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.
The agency’s classification
FDA (Food): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 31,600
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.
Part of a larger recall action
This product is one of 2 recalled by Fire Distributors Plus LLC under a single FDA (Food) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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