Class II · Moderate risk
Azelaic Acid Gel
CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received.
Is Azelaic Acid recalled?
Yes — there is an active recall. 3 ongoing FDA recalls mention Azelaic Acid (10 total). Check the affected lots below.
Most common reason: Sterility / contamination (6 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Azelaic Acid. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Azelaic Acid recalls in 2026
1 initiated in 2026, 10 in total — newest first
Class II · Moderate risk
Azelaic Acid Gel
CGMP Deviations: Market complaints received for gritty texture (grainy)
Class II · Moderate risk
Glenmark
CGMP Deviations
Class II · Moderate risk
Azelaic Acid 99.0+% Micro 500 Grams
cGMP Deviations
Class II · Moderate risk
Kojic Acid 8%/Azelaic Acid 15% Cream
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Metronidazole 1% Gel
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Azelaic Acid 15% Cream
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Acne Solution
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Clindamycin 1%
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Adapalene 0.1%
Lack of Assurance of Sterility: There are also CGMP Deviations.
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