CLASS II Drug recall · Reported 12 Nov 2014 · FDA Enforcement Report
Obagi Nu-Derm Clear, AM PM 3, Skin Bleaching recalled
Obagi Medical Products is recalling Obagi Nu-Derm Clear, AM PM 3, Skin Bleaching and Corrector Cream, Hydroquinone USP, 4%, distributed nationwide in the US. The recall was initiated on 17 Oct 2014 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-0234-2015
- FDA event ID
- 69569
- Recalling firm
- Obagi Medical Products, Irvine, CA
- Manufacturer
- Obagi Cosmeceuticals LLC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Oct 2014
- FDA classified
- 31 Oct 2014
- Reported
- 12 Nov 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Creams, Ointments & Gels
Timeline
| 17 Oct 2014 | Recall initiated by company | |
| 31 Oct 2014 | Classified by FDA | +14 days |
| 12 Nov 2014 | 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
Labeling: Label Mix-Up; Containers of the Obagi Nu-Derm Clear pre-labeled bottles were inadvertently introduced into the Obagi Exfoderm Forte packaging line. Therefore customers which ordered Clear RX actually had contents of Exfoderm forte.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Obagi Nu-Derm Clear, AM PM 3, Skin Bleaching and Corrector Cream, Hydroquinone USP, 4%, Rx Only, Net Wt. 2 OZ. (57 g) bottle, Dist by OMP Inc, Long Beach CA 90802, Made in USA, NDC 62032-101-36
Where it was distributed
Nationwide and Mexico and Slovenia
Questions about this recall
Why was it recalled?
Labeling: Label Mix-Up; Containers of the Obagi Nu-Derm Clear pre-labeled bottles were inadvertently introduced into the Obagi Exfoderm Forte packaging line. Therefore customers which ordered Clear RX actually had contents of Exfoderm forte.
Which lots are affected?
Lot #: 13I1218, Product/Part #: 362032101361, Exp 09/30/2016
Where was it sold?
Nationwide and Mexico and Slovenia
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 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.
Other Hydroquinone recalls
All 10| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Hydroquinone USP, 4% Skin Bleaching Cream recalled by Monarch PCMHydroquinone | Monarch PCM | Other | TN |
| Drug | CLASS III | Hydroquinone, USP, 4% Skin Bleaching Cream recalled by Monarch PCMHydroquinone | Monarch PCM | Potency & Assay | OH, TN |
| Drug | CLASS II | Hydroquinone/Fluocinolone/Tretonoin/Kojic Acid recalled | The Medicine Shoppe Pharmacy | Other | FL |
| Drug | CLASS II | Hydroquinone 8%/ Tretinoin 0.1% Topical Ointment recalled | KRS Global Biotechnology | Packaging Defects | Nationwide |
| Drug | CLASS II | Hydroquinone Cream in all strengths including recalled by Synergy Rx | Synergy Rx | Sterility | Nationwide |