CLASS II ONGOING Drug recall · Reported 5 Aug 2026 · FDA Enforcement Report
Azelaic Acid Gel, 15% tubes, For Topical Use only recalled
Glenmark Pharmaceuticals Inc., USA is recalling Azelaic Acid Gel, 15% tubes, For Topical Use only, distributed nationwide in the US. The recall was initiated on 23 Jul 2026 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0731-2026
- FDA event ID
- 99490
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA, Elmwood Park, NJ
- Brand
- Azelaic Acid
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 23 Jul 2026
- FDA classified
- 28 Jul 2026
- Reported
- 5 Aug 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Creams, Ointments & Gels
Timeline
| 23 Jul 2026 | Recall initiated by company | |
| 28 Jul 2026 | Classified by FDA | +5 days |
| 5 Aug 2026 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received.
Product as listed by the FDA
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.
Where it was distributed
Nationwide within the United States.
Questions about this recall
Why was it recalled?
CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received.
Which lots are affected?
Lot #: 19260937A, Exp. Date February 2028; 19261225A, 19261185A, Exp. Date March 2028; 19261664A, 19261682A, Exp. Date April 2028.
Where was it sold?
Nationwide within the United States.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Glenmark Pharmaceuticals Inc., USA
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|---|---|---|---|---|---|
| Drug | CLASS II | Alyacen 7/7/7, Norethindrone recalled by Glenmark PharmaceuticalsAlyacen 1/35 | Glenmark Pharmaceuticals Inc., USA | Potency & Assay | Nationwide |
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| Drug | CLASS III | Nebivolol Tablets, 20 mg recalled by Glenmark PharmaceuticalsNebivolol | Glenmark Pharmaceuticals Inc., USA | Other | Nationwide |
| Drug | CLASS III | Bisoprolol Fumarate and Hydrochlorothiazide Tablets recalledBisoprolol Fumarate And Hydrochlorothiazide | Glenmark Pharmaceuticals Inc., USA | Packaging Defects | Nationwide |
| Drug | CLASS II | Viorele, Desogestrel and Ethinyl Estradiol recalledViorele | Glenmark Pharmaceuticals Inc., USA | Potency & Assay | Nationwide |
Other Azelaic Acid recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Azelaic Acid Gel, 15%, For Topical Use Only recalledAzelaic Acid | Glenmark Pharmaceuticals Inc., USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Glenmark, Azelaic Acid Gel, 15 % recalled by Glenmark PharmaceuticalsAzelaic Acid | Glenmark Pharmaceuticals Inc., USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Azelaic Acid 15% Cream recalled by Synergy Rx | Synergy Rx | Sterility | Nationwide |