Glenmark Pharmaceuticals Inc., USA recalls 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 grainy, gritty, or sandy) were received.
Read the official notice →- Date
- 2026-08-05
- Country
- United States
- Brand
- Glenmark Pharmaceuticals
- Product
- Azelaic Acid Gel, 15%, 50 gram tubes, For Topical Use only, Rx only, Distributed by: Glenmark Pharmaceuticals Inc., USA, Elmwood Park, NJ…
- Classification
- Class II
- Units
- Nationwide within the United States.
- Category
- Drugs & medical
- Source
- FDA · Drug
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Glenmark Pharmaceuticals recalls
- 2026-06-24
US
Glenmark Pharmaceuticals Inc., USA recalls Alyacen 7/7/7, Norethindrone and Ethinyl Estradiol Tablets USP, 0.5mg/0.035mg, 0.75mg/0.035mg, 1 mg/0.0.35mg, 3 Blister Cards…
Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.
- 2026-01-07
US
Glenmark Pharmaceuticals Inc., USA recalls Ondansetron Orally Disintegrating Tablets, USP, 4mg, 30 Tablets (3 blistercards each containing 10 tablets), Rx only,…
Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished…
- 2025-12-17
US
- 2025-12-10
US
Glenmark Pharmaceuticals Inc., USA recalls Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 2.5 mg/6.25 mg, packaged as (a) 30-count bottles, NDC-68462-878-30;…
Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe
- 2025-10-22
US
Glenmark Pharmaceuticals Inc., USA recalls Viorele, Desogestrel and Ethinyl Estradiol, USP, 0.15 mg/ 0.02 mg and Ethinyl Estradiol Tablets, USP, 0.01 mg, 3 Blisters…
Failed Impurities/Degradation Specifications
- 2025-10-01
US
Glenmark Pharmaceuticals Inc., USA recalls Azelaic Acid Gel, 15%, 50 grams, For Topical Use Only, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited…
CGMP Deviations: Market complaints received for gritty texture (grainy)
Other drugs & medical recalls in the United States
- 2026-08-05
US
PHILIPS MEDICAL SYSTEMS recalls IQon Spectral CT IQon Spectral CT Upgrades
The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tracking shots may occur. This may result in the clinical acquisition being…
FDA · DevicePHILIPS MEDICAL SYSTEMSUS Nationwide Distribution including Puerto RicoOfficial notice →US
Ascend Laboratories, LLC recalls Dabigatran Etexilate Capsules, 75 mg, 60-count (6x10)blister pack further packaged in a carton, Rx only, Manufactured by: Alkem…
Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability
US
US
MICRO LABS USA INC recalls Dorzolamide HCl and Timolol Maleate Ophthalmic Solution, USP, 2%/0.5%, 10mL - bottle, Rx only, Manufactured by: Micro Labs Limited, India,…
Defective Container: Firm received multiple complaints of broken cap spikes and undeliverable drops.
- 2026-07-29
US
Karl Storz Endoscopy recalls Flexible Hystero-Fiberscope Kits REF: 11264BBU1, 11264BBUK1, that contain expired Single Use Endoscopic Seal: GYN, REF: 26153EAU/1.
Flexible hysteroscopes indicated for use during diagnostic and operative hysteroscopic procedures may contain an expired single use endoscopic seal for gynecology use, which could impact the assurance of sterility.
FDA · DeviceKarl Storz EndoscopyUS Nationwide distribution in the states of FL, MA, MN, TX, OH, NY, CA, MI,…Official notice →US
Alphatec Spine, Inc. recalls SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System
Intraoperative neuromonitoring device, due to a software issue, may experience loss or interruption of triggered electromyography (tEMG) functionality during use, displaying as system faults, loss of communication…
FDA · DeviceAlphatec Spine, Inc.US Nationwide distribution in the states of TX, MO, IN.Official notice →