Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
RxRecalls Get alerts
Class II · Moderate risk Terminated Initiated Jan 24, 2022 (5 years ago)

Lite Remfresh Advanced Ion-Powered Melatonin

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

cGMP deviations

Cause type: cGMP deviation

Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.

What was recalled

Lite Remfresh Advanced Ion-Powered Melatonin (Melatonin 0.5mg) Tablets, 36-count blisters, Physician's Seal LLC, Boca Raton, FL 33487

Drug: Melatonin

Recalling firm
Ultra Seal Corporation
Origin
NY, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0479-2022 · FDA notice

Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.

Other Melatonin recalls

See all

Other recalls by Ultra Seal Corporation

All 2022 recalls
Class II · Moderate risk

Sinus Relief

cGMP deviations

Terminated cGMP deviation Ultra Seal Corporation D-0518-2022