RecallRadar

FDA Food recall F-1101-2019

Klaire Labs Melatonin Lozenge Formula Fast Dissolving 1 mg tablets

On 2019-03-06 the FDA classified a Class III recall of Klaire Labs Melatonin Lozenge Formula Fast Dissolving 1 mg tablets by Prothera, citing small quantity of product labeled as Melatonin Lozenge Formula were filled with L-Theanine.

Read the official FDA Food notice

AgencyFDA Food
Recall numberF-1101-2019
ClassificationClass III
Statusterminated
Initiated2019-01-17
Published2019-03-06
Last updated2026-09-13 11:50 UTC
CompanyProthera
DistributionKS

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

Reason

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

Identifiers

upc828054178458
code_infoFG Lot 2018410057; Expiration Date 8/2020

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:50 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/food/enforcement.json?search=recall_number:%22F-1101-2019%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.