Melatonin Lozenges (Klaire Labs) – Incorrect filling (2019)
Class III: A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences
Class III recall indicates unlikely adverse health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
ProThera, Inc. dba SFI USA
Lot Codes / Batch Numbers
FG Lot 2018410057, Expiration Date 8/2020
Products Sold
FG Lot 2018410057; Expiration Date 8/2020
ProThera, Inc. dba SFI USA is recalling Klaire Labs Melatonin Lozenge Formula Fast Dissolving 1 mg tablets; Packed in a 75 cc HDPE Bottle due to Small quantity of product labeled as Melatonin Lozenge Formula were filled with L-Theanine.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Small quantity of product labeled as Melatonin Lozenge Formula were filled with L-Theanine.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IN, KS
Page updated: Jan 6, 2026