AZELAIC ACID GEL
Generic: AZELAIC ACID
Encube EthicalsManufacturer
TOPICALRoute
AZELAIC ACIDActive Substance
2018-11-19Original Approval
AZELAIC ACID GEL is FDA application ANDA208724, sponsored by ENCUBE. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.
Recalls
Class II2025-09-17
Azelaic Acid Gel, 15%, 50 grams, For Topical Use Only, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited ColvalCGMP Deviations: Market complaints received for gritty texture (grainy)
Class II2026-07-23
Azelaic Acid Gel, 15%, 50 gram tubes, For Topical Use only, Rx only, Distributed by: Glenmark Pharmaceuticals Inc., USA,CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as
Class II2024-07-22
Glenmark, Azelaic Acid Gel, 15 %, 50 grams, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Colvale-Bardez, CGMP Deviations
Top Reported Reactions
1
DRUG INEFFECTIVE
145 reports
2
PAIN
118 reports
3
OFF LABEL USE
110 reports
4
VOMITING
100 reports
5
ABDOMINAL PAIN UPPER
97 reports
6
PRODUCT USE IN UNAPPROVED INDICATION
97 reports
7
GASTROOESOPHAGEAL REFLUX DISEASE
93 reports
8
PARAESTHESIA
92 reports
9
HYPOAESTHESIA
90 reports
10
MIGRAINE
90 reports