Azelaic Acid Gel recall: CGMP Deviations
Azelaic Acid Gel, 15%, 50 grams, For Topical Use Only, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited Colvale-Bardez, Goa 403513, India…
Why was Azelaic Acid Gel recalled?
CGMP Deviations: Market complaints received for gritty texture (grainy)
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Batch # 19252524, Exp Date: May 2027
- Product
- Azelaic Acid Gel, 15%, 50 grams, For Topical Use Only, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited Colvale-Bardez, Goa 403513, India…
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
- Quantity
- 13824 tubes
- Distribution
- Nationwide within the United States
- Recall date
- October 1, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)