Severity
Low
LowClass IIITerminated
FDA Food recall · Reported March 6, 2019
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
Small quantity of product labeled as Melatonin Lozenge Formula were filled with L-Theanine.
ProThera, Inc. dba Sfi USA recalled Klaire Labs Melatonin Lozenge Formula Fast Dissolving 1 mg tablets; Packed in a 75 cc H… - a low-severity action.
Klaire Labs Melatonin Lozenge Formula Fast Dissolving 1 mg tablets; Packed in a 75 cc H… was recalled by ProThera, Inc. dba Sfi USA in March 6, 2019. Reason: Small quantity of product labeled as Melatonin Lozenge Formula were filled with L-Theanine.. Check the official notice for the remedy. Verify recall #F-1101-2019 with the FDA Food before acting.
The recall
ProThera, Inc. dba Sfi USA issued this low-severity FDA Food recall-Small quantity of product labeled as Melatonin Lozenge Formula were filled with L-Theanine..
- Low
- severity level
- Class III
- classification
- March 6, 2019
- reported
Sourced from official FDA Food enforcement records. Verify recall #F-1101-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Food action (record #F-1101-2019) was formally reported on March 6, 2019, with the manufacturer initiating the action on January 17, 2019. It is classified under Low severity (Class III), with a current status of Terminated. ProThera, Inc. dba Sfi USA is listed as the recalling firm, operating out of Reno, NV. Federal records list the affected scope as 120 bottles.
The documented reason for this recall is: Small quantity of product labeled as Melatonin Lozenge Formula were filled with L-Theanine. Distribution data in the federal record shows the product reached: One customer in KS.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Children & Baby Products recalls over time
Where this recall sits in its category - 3,772 children & baby products recalls on record
Of 88,001 recalls with an agency hazard classification, 19,020 are high severity, 64,468 moderate, and 4,513 low. A further 16,157 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
120 bottles
Related Recalls
6
0 from same agency
Product description
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
Reason for recall
Small quantity of product labeled as Melatonin Lozenge Formula were filled with L-Theanine.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | F-1101-2019 |
| Date reported | March 6, 2019 |
| Date initiated | January 17, 2019 |
| Recalling firm | ProThera, Inc. dba Sfi USA |
| Firm location | Reno, NV |
| Affected scope | 120 bottles |
| Distribution | One customer in KS. |
Profile values are sourced directly from the official FDA Food enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (F-1101-2019) and product description against the item you own. Search the archive
- Confirm the current status with FDA Food before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Food record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by ProThera, Inc. dba Sfi USA. Units affected: 120 bottles.
Why was this product recalled? ▼
Small quantity of product labeled as Melatonin Lozenge Formula were filled with L-Theanine.
Which agency issued this recall? ▼
This recall was issued by the FDA Food on March 6, 2019. Severity: Low. Recall number: F-1101-2019.
Where was the recalled product distributed? ▼
Distribution: One customer in KS..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (F-1101-2019) against your product. Visit the official FDA Food website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
What are the health risks of consuming a recalled food product? ▼
Recalled food products may contain contaminants, undeclared allergens, or harmful bacteria such as Salmonella, Listeria, or E. coli. Consuming these products can cause foodborne illness ranging from mild gastrointestinal symptoms to serious conditions requiring hospitalization. If you have consumed a recalled food product and experience symptoms, contact your healthcare provider and report to the FDA via MedWatch.
Nationwide recalls with similar severity or category timing
Two federal-filing-derived peer sets for this notice, both outside the same recalling firm and filing state so the neighborhoods are not firm or geographic containment.
Similar severity · nearest report date
Same archive severity grade (Low), closest by report date among other firms and states.
Similar Children & Baby Products · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
Showing 5 of 4006 other recalls in this category.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Food, reported March 6, 2019. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.