Glenmark Pharmaceuticals Inc., USA
Glenmark Pharmaceuticals Inc., USA appears in FDA public data with 140 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-0588-2026, Class II) was initiated on May 27, 2026.
Summary
- Total Recalls
- 140 (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-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 | December 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 | November 21, 2025 |
| D-0222-2026 | Class III | Nebivolol Tablets, 20 mg, 90 Tablets, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pi | November 18, 2025 |
| D-0662-2025 | Class II | Azelaic Acid Gel, 15%, 50 grams, For Topical Use Only, Rx only, Manufactured by: Glenmark Pharmaceut | September 17, 2025 |
| D-0021-2026 | Class II | Viorele, Desogestrel and Ethinyl Estradiol, USP, 0.15 mg/ 0.02 mg and Ethinyl Estradiol Tablets, USP | September 3, 2025 |
| D-0583-2025 | Class II | Theophylline extended-release tablets 400mg, 100-count bottle, Rx only, Manufactured by: Glenmark Ph | August 8, 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 | August 7, 2025 |
| D-0579-2025 | Class II | Carvedilol Tablets, USP, 25 mg, 500-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals | August 7, 2025 |
| D-0578-2025 | Class II | Carvedilol Tablets, USP, 12.5 mg, 500-count bottle, Rx only, Manufactured by: Glenmark Pharmaceutica | August 7, 2025 |
| D-0587-2025 | Class II | Carvedilol Tablets, USP, 12.5 mg, 500 Tablets per carton, Rx Only, Manufactured by: Glenmark Pharmac | August 6, 2025 |
| D-0588-2025 | Class II | Carvedilol Tablets, USP, 25 mg, 500 Tablets per carton, Rx Only, Manufactured by: Glenmark Pharmaceu | August 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-0338-2025 | Class II | Prochlorperazine Maleate Tablets, 10mg, 100-count bottles, Rx Only, Manufactured by: Glenmark Pharma | March 13, 2025 |
| D-0323-2025 | Class II | Rufinamide Tablets 200mg, 120-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limit | March 13, 2025 |
| D-0350-2025 | Class II | Pravastatin Sodium Tablets, USP, 80mg, a).90-count bottle (16714-570-01), b). 500-count bottle (NDC | March 13, 2025 |
| D-0325-2025 | Class II | Pravastatin Sodium Tablets 80mg, 90-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals | March 13, 2025 |
| D-0328-2025 | Class II | Metformin Hydrochloride Extended-Release Tablets 1000mg, 90-count bottle. Manufactured by: Glenmark | March 13, 2025 |
| D-0343-2025 | Class II | Lacosamide Tablets 150mg, 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limite | March 13, 2025 |