Alembic Pharmaceuticals recalls
FDA enforcement reports naming Alembic Pharmaceuticals Limited as the recalling firm.
- Recall reports
- 9
- Class I (serious)
- 1
- Most recent report
- Jan 14, 2026
- Jan 14, 2026Fesoterodine Fumarate, Extended-release Tablets, 8 mg, 30 Tablets, Rx only, Manufacture…Drug · Alembic Pharmaceuticals LimitedFailed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.Class III
- Nov 26, 2025Fesoterodine Fumarate, Extended-release Tablets, 4 mg, 30-count bottle, Rx only, Manufa…Drug · Alembic Pharmaceuticals LimitedFailed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.Class III
- Aug 13, 2025Doxepin Hydrochloride Capsules, USP, 10 mg, 100 Capsules, Rx only, Manufactured by: Ale…Drug · Alembic Pharmaceuticals LimitedCGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.Class II
- Jun 18, 2025Celecoxib Capsules, 200 mg, 500-count bottle, Rx only, Manufactured by: Alembic Pharmac…Drug · Alembic Pharmaceuticals LimitedPresence of Foreign Tablets/Capsules; customer complaint found one Tadalafil 5mg tablet inside a sealed 500-count bottle of Celecoxib 200mg capsuleClass II
- Jun 4, 2025Bromfenac Ophthalmic Solution 0Drug · Alembic Pharmaceuticals LimitedFailed Impurities/Degradation SpecificationsClass II
- Aug 23, 2023Tobramycin Opthalmic Solution USP, 0Drug · ALEMBIC PHARMACEUTICALS, INC.Failed Impurities/Degradation SpecificationsClass III
- Aug 2, 2023Diclofenac Sodium Topical Solution USP, 2% w/w, 3Drug · ALEMBIC PHARMACEUTICALS, INC.Defective Delivery SystemClass II
- Apr 14, 2021Telmisartan Tablets, USP 20 mg, 30-count bottles, Rx only, Manufactured by: Alembic Pha…Drug · Alembic Pharmaceuticals LimitedLabeling: Label-mixupClass I
- Jul 1, 2020Aripiprazole Tablets, USP, 2 mg, 30 Tablets per bottle, Rx only, Manufactured by: Alemb…Drug · Alembic Pharmaceuticals LimitedLabeling: Label mix up: Bottles labeled as aripiprazole 2 mg, 30 count had aripiprazole 5 mg tablets, 100 count.Class II