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Glenmark Pharmaceuticals Inc., USA: Azelaic Acid Gel, 15%, 50 gram tubes, For Topical Use only, Rx only, Distributed by: Glenmark Pharmaceuticals Inc., USA, Elmwood Park, NJ 07

DrugsSource: FDA (drug) · Date: 2026-08-05

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
Glenmark Pharmaceuticals Inc., USA
Product
Azelaic Acid Gel, 15%, 50 gram tubes, For Topical Use only, Rx only, Distributed by: Glenmark Pharmaceuticals Inc., USA, Elmwood Park, NJ 07407, NDC 68462-626-52.
Reason / hazard
CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received.
Classification
Class II
Status
Ongoing
Distribution / sold at
Nationwide within the United States.
Recall initiated
2026-07-23
Code info
Lot #: 19260937A, Exp. Date February 2028; 19261225A, 19261185A, Exp. Date March 2028; 19261664A, 19261682A, Exp. Date April 2028.
Product quantity
N/A
Voluntary mandated
Voluntary: Firm initiated
City
Elmwood Park
State
NJ
Country
United States
Event id
99490
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