Home / Food recalls / 2019
ProThera, Inc. dba SFI USA
FDA recall F-1101-2019 · Class III · reported 2019-03-06 · Terminated
- 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.
- Quantity
- 120 bottles
- Distribution
- One customer in KS.
- Firm location
- NV, United States
- Initiated
- Voluntary: Firm initiated
- First notice
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Recall started
- 2019-01-17
- Terminated
- 2019-03-26
- Code info
- FG Lot 2018410057; Expiration Date 8/2020
Source: U.S. Food and Drug Administration, openFDA Food Enforcement database (openFDA Food Enforcement, imported 2026-09). The FDA does not validate openFDA data for completeness or accuracy. This is a record of an enforcement action, not safety advice.