Azelaic Acid Gel, 15%, 50 gram tubes, For Topical Use only, Rx only, Distributed by: Glenmark Pharmaceuticals Inc
CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received.
- Agency
- FDA Drug
- Recall date
- Jul 23, 2026
- Status
- Ongoing
- Company
- Glenmark Pharmaceuticals Inc., USA
1. What product was recalled?
Azelaic Acid Gel, 15%, 50 gram tubes, For Topical Use only, Rx only, Distributed by: Glenmark Pharmaceuticals Inc
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.
Quantity: N/A
Code or lot text: Lot #: 19260937A, Exp. Date February 2028; 19261225A, 19261185A, Exp. Date March 2028; 19261664A, 19261682A, Exp. Date April 2028.
- LOT
- 19261185A
- LOT
- 19261225A
- LOT
- 19261664A
- LOT
- 19261682A
- LOT
- Exp. Date April 2028.
- LOT
- Exp. Date February 2028
- LOT
- Exp. Date March 2028
- LOT
- Lot #: 19260937A
- NDC
- 68462-626
- NDC
- 68462-626-52
- RECALL-NUMBER
- D-0731-2026
- UPC
- 0368462626528
2. Is my exact product affected?
Compare every printed identifier. A matching value can indicate that your product is included.
3. What is the hazard?
CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received.
4. What should I do now?
Follow the FDA recall notice and contact the recalling company for current instructions.
5. Where was it sold or distributed?
Nationwide
6. Were injuries or illnesses reported?
No separate injury or illness statement was present in the normalized record. Check the official source for the latest report.
7. What remedy is available?
Follow the FDA recall notice and contact the recalling company for current instructions.
8. Is the recall active or closed?
The source status is Ongoing. Recall Index urgency is elevated, which is a separate deterministic site label.
9. When was the information checked?
Last checked .
- unchanged
- created
10. Where is the official source?
Open the official FDA Drug source
Recall Index normalizes public source data for easier checking. Source agencies remain authoritative. Confirm identifiers and instructions at the official source.