Smiley National Recalls Kratom Supplements Due to Unapproved Ingredients
Smiley National is voluntarily recalling specific Kratom herbal dietary supplements 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 classified as FDA Class II and involves unapproved ingredients without reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Smiley National Inc is voluntarily recalling all lots of Bali Kratom 40, XL Kratom, Maeng da Kratom, and Max Kratom. These products are herbal dietary supplements sold in capsule form. The recall is being conducted due to the presence of unapproved dietary ingredients in the products.
The affected products include the All Natural, XL Kratom, Herbal Dietary Supplement, capsule, identified by UPC code 5410600307, with 4 capsules per package. The total quantity involved in the recall is 2,880 units. The products were distributed nationwide, with no foreign, military, government, or VA consignees.
Consumers who have purchased these products should stop using them and contact the recalling firm for further instructions or a refund. The FDA has classified this recall as Class II, indicating that use of the product may cause temporary or medically reversible health consequences.
The recalled product
- Product
- All Natural, XL Kratom, Herbal Dietary Supplement, capsule, UPC code 5410600307, 4 capsules per package.
- Manufacturer
- Smiley National Inc
- Category
- Food — Dietary Supplement
- Hazard
- Affected units
- 2,880
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 5410600307
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 →Related recalls
Same manufacturer · Smiley National Inc
See all →- ModerateSmiley National Recalls Kratom Supplements Due to Unapproved Ingredients
FDA (Food) · 2014-04-16
- ModerateSmiley National Recalls Kratom Products Due to Unapproved Ingredients
FDA (Food) · 2014-04-16
- ModerateSmiley National Recalls Kratom Products Due to Unapproved Dietary Ingredients
FDA (Food) · 2014-04-16
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