Class II · Moderate risk
Hydroquinone USP
Finished product specification did not meet USP specifications.
Hydroquinone
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Subpotency: one product for active ingredient assay and another one for preservative assay
Cause type: Wrong potency / content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.
What was recalled
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
Affected NDC
69367-0174-01
Compare with the code on your package — it is the most precise check available.
Drug: Hydroquinone
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Hydroquinone NDC 69367-0174 |
40 mg/g | Cream Topical |
Westminster Pharmaceuticals, LLC | Rx |
- Recalling firm
- Monarch PCM, LLC
- NDC code
- 69367-174-01
- Origin
- TX, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0818-2021 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Hydroquinone recalls
See all
Class II · Moderate risk
DCL AHA Lightening Gel
GMP Deviations
Class II · Moderate risk
Hydroquinone/Fluocinolone/Tretonoin/Kojic Acid 4/0.01/0.05/2% Cream 30 gm tube
Lack of Processing Control
Class II · Moderate risk
Dermanak original crema blanqueador
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Class II · Moderate risk
eb5 Skincare that Works. Age Spot Treatment. Skin Lightening…
Failed Stability Specifications: Out-of-specification for viscosity, pH and specific gravity
Other recalls by Monarch PCM, LLC
All 2021 recalls
Class III · Low risk
Phenobarbital Elixir
Does Not Meet USP or OTC Monograph: Product exceeds USP specification for alcohol content
Class II · Moderate risk
Hydroquinone USP
Finished product specification did not meet USP specifications.
Class III · Low risk
Sodium Sulfacetamide
Subpotency: one product for active ingredient assay and another one for preservative assay
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