CLASS II Drug recall · Reported 6 Oct 2021 · FDA Enforcement Report
Hydroquinone USP, 4% Skin Bleaching Cream recalled by Monarch PCM
Monarch PCM is recalling Hydroquinone USP, 4% Skin Bleaching Cream, distributed in Tennessee. The recall was initiated on 23 Sep 2021 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-0855-2021
- FDA event ID
- 88755
- Recalling firm
- Monarch PCM, Fort Worth, TX
- Brand
- Hydroquinone
- Manufacturer
- Westminster Pharmaceuticals, LLC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Sep 2021
- FDA classified
- 27 Sep 2021
- Reported
- 6 Oct 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Creams, Ointments & Gels
Timeline
| 23 Sep 2021 | Recall initiated by company | |
| 27 Sep 2021 | Classified by FDA | +4 days |
| 6 Oct 2021 | 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
Finished product specification did not meet USP specifications.
Product as listed by the FDA
Hydroquinone USP, 4% Skin Bleaching Cream, Rx only, Net Wt 1 oz (28.35g), Manufactured for: Westminster Pharmaceuticals, LLC Nashville, TN 37217 NDC 69367-174-01
Where it was distributed
TN
Questions about this recall
Why was it recalled?
Finished product specification did not meet USP specifications.
Which lots are affected?
Lots: 21FP1743, 21FP1745 Exp. 05/2023
Where was it sold?
TN
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.
More recalls from Monarch PCM
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Phenobarbital Elixir, USP 20 mg/, 1 Pint recalled by Monarch PCM | Monarch PCM | Other | TN |
| Food | CLASS II | Ferretts IPS Iron Liquid Dietary Supplement Iron Protein recalledFerretts IPS | Monarch PCM | Potency & Assay | UT |
| Drug | CLASS III | Sodium Sulfacetamide, 10%, Wash recalled by Monarch PCM | Monarch PCM | Potency & Assay | OH, TN |
| Drug | CLASS III | Hydroquinone, USP, 4% Skin Bleaching Cream recalled by Monarch PCMHydroquinone | Monarch PCM | Potency & Assay | OH, TN |
Other Hydroquinone recalls
All 10| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| 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 |
| Drug | CLASS II | Hydroquinone Solution in all strengths including recalled by Synergy Rx | Synergy Rx | Sterility | Nationwide |