CLASS III Food recall · Reported 6 Mar 2019 · FDA Enforcement Report
Klaire Labs Melatonin Lozenge Formula Fast Dissolving recalled
ProThera is recalling Klaire Labs Melatonin Lozenge Formula Fast Dissolving, distributed in Kansas. The recall was initiated on 17 Jan 2019 and the FDA has classified it as Class III.
Check your package
Do not eat it. Return it to the store for a refund or throw it away. If you have symptoms after eating it, contact a doctor.
Recall details
- Recall number
- F-1101-2019
- FDA event ID
- 82010
- Recalling firm
- ProThera, Reno, NV
- Brand
- Klaire Labs
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 17 Jan 2019
- FDA classified
- 27 Feb 2019
- Reported
- 6 Mar 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Product category
- Other
Timeline
| 17 Jan 2019 | Recall initiated by company | |
| 27 Feb 2019 | Classified by FDA | +41 days |
| 6 Mar 2019 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Small quantity of product labeled as Melatonin Lozenge Formula were filled with L-Theanine.
Product as listed by the FDA
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
Where it was distributed
One customer in KS.
Questions about this recall
Why was it recalled?
Small quantity of product labeled as Melatonin Lozenge Formula were filled with L-Theanine.
Which lots are affected?
FG Lot 2018410057; Expiration Date 8/2020
Where was it sold?
One customer in KS.
What should I do if I have it?
Do not eat it. Return it to the store for a refund or throw it away. If you have symptoms after eating it, contact a doctor.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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