The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Food)·F-1758-2014·Announced 2014-04-16

Smiley National Recalls Kratom Products Due to Unapproved Ingredients

Smiley National is voluntarily recalling four kratom products because they contain unapproved dietary ingredients.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is a voluntary precautionary action for unapproved dietary ingredients without reported illnesses or injuries, fitting the Moderate severity criteria.

Plain-English summary

Smiley National is voluntarily recalling all lots of Bali Kratom 40, XL Kratom, Maeng da Kratom, and Max Kratom. The recall is due to the presence of unapproved dietary ingredients in these products.

The recalled products are capsules. The specific product identified in the metadata is Natural Bali Kratom 40, capsule, UPC code 5410600335, 20 capsules per bottle. The distribution was nationwide, with no foreign, military, government, or VA consignees.

Consumers should stop using these products and follow the instructions provided by the recalling firm for disposal or return.

The recalled product

Product
Natural Bali Kratom 40, capsule, UPC code 5410600335, 20 capsules per bottle.
Affected units
900

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)

  • UPC code 5410600335

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by Smiley National Inc 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.

See all 4 products in this recall →

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