Alembic Pharmaceuticals Limited
FDA Regulatory Profile
Summary
- Total Recalls
- 7 (1 Class I)
- 510(k) Clearances
- 0
- Inspections
- 16
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| D-0248-2026 | Class III | Fesoterodine Fumarate, Extended-release Tablets, 8 mg, 30 Tablets, Rx only, Manufactured by: Alembic | December 16, 2025 |
| D-0156-2026 | Class III | Fesoterodine Fumarate, Extended-release Tablets, 4 mg, 30-count bottle, Rx only, Manufactured by: Al | October 10, 2025 |
| D-0566-2025 | Class II | Doxepin Hydrochloride Capsules, USP, 10 mg, 100 Capsules, Rx only, Manufactured by: Alembic Pharmace | July 25, 2025 |
| D-0459-2025 | Class II | Celecoxib Capsules, 200 mg, 500-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limi | May 9, 2025 |
| D-0447-2025 | Class II | Bromfenac Ophthalmic Solution 0.09%, 1.7 mL bottle, Rx only, Sterile, Manufactured for: Alembic Phar | May 7, 2025 |
| D-0326-2021 | Class I | Telmisartan Tablets, USP 20 mg, 30-count bottles, Rx only, Manufactured by: Alembic Pharmaceuticals | March 17, 2021 |
| D-1341-2020 | Class II | Aripiprazole Tablets, USP, 2 mg, 30 Tablets per bottle, Rx only, Manufactured by: Alembic Pharmaceut | June 10, 2020 |