SFI USA recalls melatonin lozenges with L-Theanine contamination
SFI USA recalls melatonin loz: Klaire Labs 1mg fast dissolving tablets with L-Theanine contamination. No remedy provided in official notice.
Recall notice
Small quantity of product labeled as Melatonin Lozenge Formula were filled with L-Theanine.
Contact the company
What happened, in plain English
SFI USA has recalled Klaire Labs melatonin lozenges that were mistakenly filled with L-Theanine instead of melatonin. This could cause confusion about the product's actual contents. Read more at govinfonow.com/recall/17803-sfi-usa-recalls-melatonin-lozenges-with-l-theanine-contamination.
Source Summary by GovInfoNow · govinfonow.com/recall/17803-sfi-usa-recalls-melatonin-lozenges-with-l-theanine-contamination · Updated October 5, 2026 · FDA enforcement record: FDA #F-1101-2019
Cite this page
“SFI USA recalls melatonin lozenges with L-Theanine contamination.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/17803-sfi-usa-recalls-melatonin-lozenges-with-l-theanine-contamination. Based on FDA recall #F-1101-2019 (https://api.fda.gov/food/enforcement.json?search=recall_number:%22F-1101-2019%22&limit=1).
Why it’s dangerous
The product was labeled as melatonin but contained L-Theanine instead. L-Theanine is a different compound that may not have the intended sleep effects and could lead to incorrect usage.
Who’s affected
People who purchased Klaire Labs melatonin lozenges with the specific UPC 8 28054 17845 8 and SKU ML1 from the manufacturer. Those using melatonin for sleep may be at risk of incorrect dosing.
How to tell if you have this one
Check for the UPC 8 28054 17845 8 on the bottle or SKU ML1. The product was sold in 75 cc HDPE bottles with 60 tablets, expiring 8/2020.
- Brand
SFI USA- Product
Klaire Labs Melatonin Lozenge Formula Fast Dissolving 1 mg tablets; Packed in a 75 cc HDPE Bottle 60 Tablets UPC: 8- Category
Food
What to do — step by step
Check Product Details
Look for the UPC 8 28054 17845 8 or SKU ML1 on the bottle to confirm if it's the recalled item.
Where it went and when
Where it was distributed
Distributed in Kansas.
FDA distribution: “One customer in KS.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Kansas.
Recall timeline
FDA terminated this recall 2 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #F-1101-2019 (January 17, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for F-1101-2019 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.