CLASS III Drug recall · Reported 29 Sep 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 Ohio, Tennessee. The recall was initiated on 1 Sep 2021 and the FDA has classified it as Class III.
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-0818-2021
- FDA event ID
- 88598
- Recalling firm
- Monarch PCM, Fort Worth, TX
- Brand
- Hydroquinone
- Manufacturer
- Westminster Pharmaceuticals, LLC
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 1 Sep 2021
- FDA classified
- 20 Sep 2021
- Reported
- 29 Sep 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Potency & Assay
- Drug class
- Creams, Ointments & Gels
Timeline
| 1 Sep 2021 | Recall initiated by company | |
| 20 Sep 2021 | Classified by FDA | +19 days |
| 29 Sep 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
Subpotency: one product for active ingredient assay and another one for preservative assay
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Hydroquinone, USP, 4% Skin Bleaching Cream, packaged in 1 oz (28.35g) tube, Rx only, Manufactured for: Westminster Pharmaceuticals, LLC Nashville, TN 37217, NDC 69367-174-01 UPC 3 69367 17401 5
Where it was distributed
OH, TN
Questions about this recall
Why was it recalled?
Subpotency: one product for active ingredient assay and another one for preservative assay
Which lots are affected?
Lot: 21FP1731 Exp 05/2023
Where was it sold?
OH, 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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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 products in this recall event
1 other product · FDA event 88598| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Sodium Sulfacetamide, 10%, Wash recalled by Monarch PCM | Monarch PCM | Potency & Assay | OH, TN |
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 |
| Drug | CLASS II | Hydroquinone USP, 4% Skin Bleaching Cream recalled by Monarch PCMHydroquinone | 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 |
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 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 |