Glenmark Pharmaceuticals Inc., USA
Glenmark Pharmaceuticals Inc., USA appears in FDA public data with 141 recalls — including 2 Class I (most serious) —, 0 510(k) clearances, 3 FDA inspections, and 3 compliance actions on record. Its most recent recall (D-0731-2026, Class II) was initiated on Jul 23, 2026.
Summary
- Total Recalls
- 141 (2 Class I)
- 510(k) Clearances
- 0
- Inspections
- 3
- Compliance Actions
- 3
Known Names
Glenmark Pharmaceuticals Inc., Usa, Glenmark Pharmaceuticals Inc Usa, Glenmark Pharmaceuticals Inc. Usa
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| D-0731-2026 | Class II | Azelaic Acid Gel, 15%, 50 gram tubes, For Topical Use only, Rx only, Distributed by: Glenmark Pharma | Jul 23, 2026 |
| D-0588-2026 | Class II | Alyacen 7/7/7, Norethindrone and Ethinyl Estradiol Tablets USP, 0.5mg/0.035mg, 0.75mg/0.035mg, 1 mg/ | May 27, 2026 |
| D-0246-2026 | Class II | Ondansetron Orally Disintegrating Tablets, USP, 4mg, 30 Tablets (3 blistercards each containing 10 t | Dec 30, 2025 |
| D-0199-2026 | Class III | Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 2.5 mg/6.25 mg, packaged as (a) 30-count b | Nov 21, 2025 |
| D-0222-2026 | Class III | Nebivolol Tablets, 20 mg, 90 Tablets, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pi | Nov 18, 2025 |
| D-0662-2025 | Class II | Azelaic Acid Gel, 15%, 50 grams, For Topical Use Only, Rx only, Manufactured by: Glenmark Pharmaceut | Sep 17, 2025 |
| D-0021-2026 | Class II | Viorele, Desogestrel and Ethinyl Estradiol, USP, 0.15 mg/ 0.02 mg and Ethinyl Estradiol Tablets, USP | Sep 3, 2025 |
| D-0583-2025 | Class II | Theophylline extended-release tablets 400mg, 100-count bottle, Rx only, Manufactured by: Glenmark Ph | Aug 8, 2025 |
| D-0578-2025 | Class II | Carvedilol Tablets, USP, 12.5 mg, 500-count bottle, Rx only, Manufactured by: Glenmark Pharmaceutica | Aug 7, 2025 |
| D-0577-2025 | Class II | Carvedilol Tablets, USP, 3.125 mg, Packaged as: a)500-count bottle, NDC 68462-162-05; b) 100-count b | Aug 7, 2025 |
| D-0579-2025 | Class II | Carvedilol Tablets, USP, 25 mg, 500-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals | Aug 7, 2025 |
| D-0587-2025 | Class II | Carvedilol Tablets, USP, 12.5 mg, 500 Tablets per carton, Rx Only, Manufactured by: Glenmark Pharmac | Aug 6, 2025 |
| D-0588-2025 | Class II | Carvedilol Tablets, USP, 25 mg, 500 Tablets per carton, Rx Only, Manufactured by: Glenmark Pharmaceu | Aug 6, 2025 |
| D-0462-2025 | Class III | Ezetimibe and Simvastatin Tablets, 10mg/40mg, 90-count bottle, Rx only, Manufactured by: Glenmark Ph | May 19, 2025 |
| D-0452-2025 | Class II | Theophylline (Anhydrous) Extended-Release Tablets, 600 mg, 100 Tablets per bottle, Rx Only, Manufact | May 15, 2025 |
| D-0321-2025 | Class II | Lacosamide Tablets 200mg, 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limite | Mar 13, 2025 |
| D-0330-2025 | Class II | Lacosamide Tablets, 100mg , 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limi | Mar 13, 2025 |
| D-0318-2025 | Class II | Voriconazole Tablets 200 mg, 30-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Lim | Mar 13, 2025 |
| D-0341-2025 | Class II | Pravastatin Sodium Tablets, 20mg, a).500-count bottle (NDC# 68462-196-05), b). 90-count bottle (NDC# | Mar 13, 2025 |
| D-0324-2025 | Class II | Nitroglycerin Sublingual Tablets 0.4MG 100-count carton, Rx Only, Manufactured by: Glenmark Pharmac | Mar 13, 2025 |