Azelaic Acid Gel, 15%, 50 gram tubes, For Topical Use only, Rx only, Distributed by: Glenmark Pharmaceuticals Inc., USA,
Summary
The FDA issued a Class II for Azelaic Acid Gel, 15%, 50 gram tubes, For Topical Use only, Rx only, Distributed by Glenmark Pharmaceuticals Inc., USA. Reason: CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received..
Details
Source
Drug Recall
External ID
D-0731-2026
Action Date
2026-08-05
Status
Ongoing
Category
drug
Product Description
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.
Lot/Code Info: Lot #: 19260937A, Exp. Date February 2028; 19261225A, 19261185A, Exp. Date March 2028; 19261664A, 19261682A, Exp. Date April 2028.
Quantity Affected: N/A
Reason for Recall
CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received.
Distribution
Nationwide within the United States.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-07-23
Company
Elmwood Park, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 35 drug recalls issued in the same week, part of 63 drug-related FDA actions this month.
Glenmark Pharmaceuticals Inc., USA has 124 FDA actions in our database, including 124 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Glenmark Pharmaceuticals Inc., USA) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Glenmark Pharmaceuticals Inc., USA have FDA actions?
Glenmark Pharmaceuticals Inc., USA has 124 FDA actions in our database, including 124 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0731-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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