Klaire Labs Melatonin Lozenge Formula Recalled Due to Incorrect Ingredient
ProThera, Inc. is recalling 120 bottles of Klaire Labs Melatonin Lozenge Formula because the product was filled with L-Theanine instead of melatonin.
The agency’s classification
FDA (Food): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 III, which indicates the product is not likely to cause adverse health consequences. The hazard involves a labeling/filling error where the wrong ingredient (L-Theanine) was used, which is a minor labeling or formulation error without reported illness.
Plain-English summary
ProThera, Inc. dba SFI USA is recalling 120 bottles of Klaire Labs Melatonin Lozenge Formula Fast Dissolving 1 mg tablets. The recall was initiated because a small quantity of the product labeled as Melatonin Lozenge Formula was filled with L-Theanine instead of the intended ingredient.
The affected product is packed in a 75 cc HDPE Bottle containing 60 tablets. The specific lot number is FG Lot 2018410057, with an expiration date of 8/2020. The product was distributed to one customer in Kansas.
Consumers who have purchased this product should check their inventory for the specific lot number and expiration date listed above. If they possess the affected product, they should stop using it and contact the recalling firm for instructions on how to return the product or obtain a refund.
The recalled product
- Product
- Klaire Labs Melatonin Lozenge Formula Fast Dissolving 1 mg tablets; Packed in a 75 cc HDPE Bottle 60 Tablets UPC: 8 28054 17845 8; SKU: ML1
- Manufacturer
- ProThera, Inc. dba SFI USA
- Category
- Food — Dietary Supplement
- Affected units
- 120
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 (2)
- FG Lot 2018410057
- Expiration Date 8/2020
Distribution
Distributed in 1 state:
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