Recall · openFDA Food Enforcement

Klaire Labs Melatonin Lozenge Formula Fast Dissolving 1 mg…: FDA Recall F-1101-2019

Agency action: Jan 17, 2019Record ID: F-1101-2019
View official source ↗

What happened

Original notice title

Klaire Labs Melatonin Lozenge Formula Fast Dissolving 1 mg tablets, recall F-1101-2019

From the archived source record

Small quantity of product labeled as Melatonin Lozenge Formula were filled with L-Theanine.

What the official notice says to do

Check the original notice for the instructions that apply to the named product, company, and affected lots.

Read the official notice →

Status and source details

Status recorded in the archive
Terminated
FDA recall classification
Class III
Recall initiated by
Voluntary: Firm initiated
Report date
Mar 6, 2019
Termination date in the archive
Mar 26, 2019
Source checked
Jul 16, 2026
Record revision
76183c8b9f2f

This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.

Sources, dates, and coverage →

What is affected

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
Company
ProThera, Inc. dba SFI USA
Lot / identifier
FG Lot 2018410057; Expiration Date 8/2020
Market / distribution
One customer in KS.