Alembic Pharmaceuticals Limited recalls

5 recalls on record · latest: December 16, 2025

Official U.S. recall history for Alembic Pharmaceuticals Limited, compiled from official government records.

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Alembic Pharmaceuticals Limited recalls Fesoterodine Fumarate, Extended-release Tablets, 8 mg, 30 Tablets, Rx only, Manufactured by: Alembic Pharmaceuticals Li…

December 16, 2025 · Drug & medication recalls Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurit…

Alembic Pharmaceuticals Limited recalls Fesoterodine Fumarate, Extended-release Tablets, 4 mg, 30-count bottle, Rx only, Manufactured by: Alembic Pharmaceutica…

October 10, 2025 · Drug & medication recalls Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurit…

Doxepin Hydrochloride Capsules recalled over manufacturing violations

July 25, 2025 · Drug & medication recalls Moderate risk CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above…

Alembic Pharmaceuticals Limited recalls Celecoxib Capsules, 200 mg, 500-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Di…

May 9, 2025 · Drug & medication recalls Moderate risk Presence of Foreign Tablets/Capsules; customer complaint found one Tadalafil 5m…

Alembic Pharmaceuticals Limited recalls Bromfenac Ophthalmic Solution 0.09%, 1.7 mL bottle, Rx only, Sterile, Manufactured for: Alembic Pharmaceuticals, Inc.,…

May 7, 2025 · Drug & medication recalls Moderate risk Failed Impurities/Degradation Specifications