CLASS II Drug recall · Reported 9 Feb 2022 · FDA Enforcement Report
Lite Remfresh Advanced Ion-Powered Melatonin recalled by Ultra Seal
Ultra Seal is recalling Lite Remfresh Advanced Ion-Powered Melatonin (Melatonin 5mg) Tablets blisters, distributed nationwide in the US. The recall was initiated on 24 Jan 2022 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0479-2022
- FDA event ID
- 89464
- Recalling firm
- Ultra Seal, New Paltz, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Jan 2022
- FDA classified
- 31 Jan 2022
- Reported
- 9 Feb 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Vitamins & OTC Supplements
Timeline
| 24 Jan 2022 | Recall initiated by company | |
| 31 Jan 2022 | Classified by FDA | +7 days |
| 9 Feb 2022 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
cGMP deviations
Product as listed by the FDA
Lite Remfresh Advanced Ion-Powered Melatonin (Melatonin 0.5mg) Tablets, 36-count blisters, Physician's Seal LLC, Boca Raton, FL 33487
Where it was distributed
Nationwide within the United States
Questions about this recall
Is Lite Remfresh Advanced Ion-Powered Melatonin (Melatonin 5mg) Tablets blisters recalled?
Yes. Ultra Seal recalled Lite Remfresh Advanced Ion-Powered Melatonin (Melatonin 5mg) Tablets blisters on 24 Jan 2022. The recall is Class II and its status is Terminated. Recall number D-0479-2022.
Why was it recalled?
cGMP deviations
Which lots are affected?
Lot #: 19E058A, 19E058B, Exp. Date 05/2022
Where was it sold?
Nationwide within the United States
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Ultra Seal
All 66| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Multi-Symptom Cramp Relief (acetaminophen 325mg recalled by Ultra Seal | Ultra Seal | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Electrolyte Supplement Tablets (calcium 2 mg recalled by Ultra Seal | Ultra Seal | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Cetafen Cough & Cold Cough & Cold Relief recalled by Ultra Seal | Ultra Seal | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | REMfresh Advanced Ion-Powered Melatonin (Melatonin 5 mg) Caplets recalled | Ultra Seal | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Sinus Decongestant Nasal Decongestant recalled by Ultra Seal | Ultra Seal | Manufacturing (CGMP) Deviations | Nationwide |