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Alembic Pharmaceuticals Limited FDA Recalls
6 recalls on file across drugs, 1 of them Class I and 5 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Fesoterodine Fumarate, Extended-release Tablets, 8 mg, 30 Tablets, Rx only, Manufactured by: Alembic Pharmaceuticals LimClass IIIDec 16, 2025Failed Impurities/Degradation Specifications: Due to levels |
| Fesoterodine Fumarate, Extended-release Tablets, 4 mg, 30-count bottle, Rx only, Manufactured by: Alembic PharmaceuticalClass IIIOct 10, 2025Failed Impurities/Degradation Specifications: Due to levels |
| Doxepin Hydrochloride Capsules, USP, 10 mg, 100 Capsules, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, PanClass IIJul 25, 2025CGMP Deviations: Presence of Nitrosamine Drug Substance Rela |
| Celecoxib Capsules, 200 mg, 500-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation DivClass IIMay 9, 2025Presence of Foreign Tablets/Capsules; customer complaint fou |
| Bromfenac Ophthalmic Solution 0.09%, 1.7 mL bottle, Rx only, Sterile, Manufactured for: Alembic Pharmaceuticals, Inc., BClass IIMay 7, 2025Failed Impurities/Degradation Specifications |
| Telmisartan Tablets, USP 20 mg, 30-count bottles, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (FormulationClass IMar 17, 2021Labeling: Label-mixup |