CLASS II Drug recall · Reported 19 Oct 2022 · FDA Enforcement Report
Skincell Mole & Skin Corrector Serum recalled by Justified Laboratories
Justified Laboratories is recalling Skincell Mole & Skin Corrector Serum, distributed in Puerto Rico. The recall was initiated on 9 Sep 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-0009-2023
- FDA event ID
- 90828
- Recalling firm
- Justified Laboratories, Arlington, TX
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Sep 2022
- FDA classified
- 7 Oct 2022
- Reported
- 19 Oct 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Hidden Drug Ingredients
Timeline
| 9 Sep 2022 | Recall initiated by company | |
| 7 Oct 2022 | Classified by FDA | +28 days |
| 19 Oct 2022 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Marketed Without An Approved NDA/ANDA; Unapproved new drug
Products marketed as supplements sometimes contain undeclared prescription drug ingredients such as sildenafil or sibutramine. These can interact dangerously with other medicines.
Product as listed by the FDA
Skincell Mole & Skin Corrector Serum, 1 fl. oz./30 mL jars, Distributed By: Justified Laboratoires, Arlington, TX 76011 USA UPC 8 10077 53221 8
Where it was distributed
United States including Puerto Rico and Canada
Questions about this recall
Why was it recalled?
Marketed Without An Approved NDA/ANDA; Unapproved new drug
Which lots are affected?
All lots remaining within expiry.
Where was it sold?
United States including Puerto Rico and Canada
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.
Other products in this recall event
1 other product · FDA event 90828This product is part of a recall event; the main page for the event is Skincell Mole & Skin Corrector Serum recalled by Justified Laboratories.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Skincell Mole & Skin Corrector Serum recalled by Justified Laboratories | Justified Laboratories | Hidden Drug Ingredients | PR |
More recalls from Justified Laboratories
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Skincell Mole & Skin Corrector Serum recalled by Justified Laboratories | Justified Laboratories | Hidden Drug Ingredients | PR |