Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Glenmark Pharmaceuticals Limited | Goa, India | Makes it and tests it | Problems found, fixed voluntarilyJun 30, 2026 · 7 inspections, 1 with FDA action |
Recalls
- Jul 23, 2026 · Class II · Glenmark Pharmaceuticals Inc., USA
CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received.
Lots: Lot #: 19260937A, Exp. Date February 2028; 19261225A, 19261185A, Exp. Date March 2028; 19261664A, 19261682A, Exp. Date April 2028. - Sep 17, 2025 · Class II · Glenmark Pharmaceuticals Inc., USA
CGMP Deviations: Market complaints received for gritty texture (grainy)
Lots: Batch # 19252524, Exp Date: May 2027 - Jul 22, 2024 · Class II · Glenmark Pharmaceuticals Inc., USA
CGMP Deviations
Lots: Lot# 19241453; Exp MARCH 2026
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Azelaic Acid: every company that makes it
- Form
- gel, topical
- Strength
- 0.15 g per 1 g
- Approval
- ANDA ANDA204637
- On the market since
- Nov 19, 2018
- Package NDCs
68462-626-52- Official label
- DailyMed (National Library of Medicine), updated Dec 23, 2021
Got it by mail or from a pharmacy you don't know? Look the pharmacy up on Who Filled My Rx?