Glenmark Pharmaceuticals Inc., USA 2026-08-05 Health serious FDA
Health · FDA · Recall #FDA-D-0731-2026
Azelaic Acid Gel, 15%, 50 gram tubes, For Topical Use only, Rx only, Distributed by:… Recall
Issued August 5, 2026 · Glenmark Pharmaceuticals Inc., USA
In August 2026, Glenmark Pharmaceuticals Inc., USA recalled the Azelaic Acid Gel, 15%, 50 gram tubes, For Topical Use only, Rx only, Distributed by:…, a serious health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Dana Whitfield, RecallCheckr
What this means for you
CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received.
What you should do
- 1 Stop using Azelaic Acid Gel, 15%, 50 gram tubes, For Topical Use only, Rx only, Distributed by:… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Glenmark Pharmaceuticals Inc., USA to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Glenmark Pharmaceuticals Inc., USA
- Category
- Health
- Recall date
- August 5, 2026
- Units affected
- Not reported
- Sold at
- Nationwide within the United States.
- Recall number
- FDA-D-0731-2026
- Made in
- United States
- Issuing agency
- FDA
In context
- Glenmark Pharmaceuticals Inc., USA has 54 recalls in our database.
- We're tracking 3,707 Health recalls in our database.
- This is the 487th Health recall we've logged in 2026.