Class II · Moderate risk
Hydroquinone USP
Finished product specification did not meet USP specifications.
Is Hydroquinone recalled?
Not under an active recall.
Hydroquinone was recalled 28 times in the past — all now closed. Most recent: Sep 23, 2021.
Most common reason: Sterility / contamination (19 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Hydroquinone. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Hydroquinone recalls on record
none so far in 2026; 28 on record, newest first
Class III · Low risk
Hydroquinone
Subpotency: one product for active ingredient assay and another one for preservative assay
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
Class II · Moderate risk
Hydroquinone 8%/ Tretinoin 0.1% Topical Ointment packaged in jars
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Class II · Moderate risk
Hydroquinone 28% Solution
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
HYDROQUINONE CREAM in all strengths including: 4%
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Tri-Bleaching Cream
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Ultra Lite Cream
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Tri-Bleaching Cream Hq
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Tri-Bleaching Cream
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Tri-Bleaching Cream
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Supreme Cream
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Supreme Bleaching Cream
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Quad Bleaching Cream
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Malek's Magic Plus
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Malek's Magic
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
HI-LITE Cream
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Firm and Fade
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
DUO Cream
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Brightening Cream
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
HYDROQUINONE SOLUTION in all strengths including 4%
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
HYDROQUINONE CREAM in all strengths including 4%
Lack of Assurance of Sterility: There are also CGMP Deviations.
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