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Alembic Pharmaceuticals Recalls
9 recalls on record · July 1, 2020 to January 14, 2026 · Drugs
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
January 14, 2026DrugsFDA
Alembic Pharmaceuticals Limited recalls Fesoterodine Fumarate, Extended-release Tablets, 8 mg, 30 Tablets, Rx only, Manufactured by: Alembic Pharmaceuticals Lim
Hazard: Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
November 26, 2025DrugsFDA
Alembic Pharmaceuticals Limited recalls Fesoterodine Fumarate, Extended-release Tablets, 4 mg, 30-count bottle, Rx only, Manufactured by: Alembic Pharmaceutical
Hazard: Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
August 13, 2025DrugsFDA
Alembic Pharmaceuticals Limited recalls Doxepin Hydrochloride Capsules, USP, 10 mg, 100 Capsules, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Pan
Hazard: CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
June 18, 2025DrugsFDA
Alembic Pharmaceuticals Limited recalls Celecoxib Capsules, 200 mg, 500-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Div
Hazard: Presence of Foreign Tablets/Capsules; customer complaint found one Tadalafil 5mg tablet inside a sealed 500-count bottle of Celecoxib 200mg capsule
June 4, 2025DrugsFDA
Alembic Pharmaceuticals Limited recalls Bromfenac Ophthalmic Solution 0.09%, 1.7 mL bottle, Rx only, Sterile, Manufactured for: Alembic Pharmaceuticals, Inc., B
Hazard: Failed Impurities/Degradation Specifications
August 23, 2023DrugsFDA
ALEMBIC PHARMACEUTICALS, INC. recalls Tobramycin Opthalmic Solution USP, 0.3%, 5mL bottle, Rx only, Manufactured for: Alembic Pharmaceuticals, Bedminster, NJ
Hazard: Failed Impurities/Degradation Specifications
August 2, 2023DrugsFDA
ALEMBIC PHARMACEUTICALS, INC. recalls Diclofenac Sodium Topical Solution USP, 2% w/w, 3.8 FL.OZ.(112 grams) bottles, Rx only, Manufactured for: Alembic Pharm
Hazard: Defective Delivery System
April 14, 2021DrugsFDA
Alembic Pharmaceuticals Limited recalls Telmisartan Tablets, USP 20 mg, 30-count bottles, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation
Hazard: Labeling: Label-mixup
July 1, 2020DrugsFDA
Alembic Pharmaceuticals Limited recalls Aripiprazole Tablets, USP, 2 mg, 30 Tablets per bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formu
Hazard: Labeling: Label mix up: Bottles labeled as aripiprazole 2 mg, 30 count had aripiprazole 5 mg tablets, 100 count.