Alembic Pharmaceuticals recalls
Alembic Pharmaceuticals appears in 9 official U.S. recall notices indexed by RecallRadar, most recently on 2026-01-14.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 9 |
|---|---|
| Published | 2020-07-01 to 2026-01-14 |
| By agency | FDA Drug (9) |
| By classification | Class II (5), Class III (3), Class I (1) |
| By status | ongoing (7), terminated (2) |
| Distribution named in notices | US |
Recalls
- Fesoterodine Fumarate, Extended-release Tablets, 8 mg, 30 Tablets, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panelav 38935…
FDA Drug · Class III · 2026-01-14 · Alembic Pharmaceuticals
Reason: Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit. - Fesoterodine Fumarate, Extended-release Tablets, 4 mg, 30-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panelav…
FDA Drug · Class III · 2025-11-26 · Alembic Pharmaceuticals
Reason: Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit. - Doxepin Hydrochloride Capsules, USP, 10 mg, 100 Capsules, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panela v 389350, Gujar…
FDA Drug · Class II · 2025-08-13 · Alembic Pharmaceuticals
Reason: CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit. - Celecoxib Capsules, 200 mg, 500-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division), Panelav 389…
FDA Drug · Class II · 2025-06-18 · Alembic Pharmaceuticals
Reason: Presence of Foreign Tablets/Capsules; customer complaint found one Tadalafil 5mg tablet inside a sealed 500-count bottle of Celecoxib 200mg capsule - Bromfenac Ophthalmic Solution 0.09%, 1.7 mL bottle, Rx only, Sterile, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921…
FDA Drug · Class II · 2025-06-04 · Alembic Pharmaceuticals
Reason: Failed Impurities/Degradation Specifications - Tobramycin Opthalmic Solution USP, 0.3%, 5mL bottle, Rx only, Manufactured for: Alembic Pharmaceuticals, Bedminster, NJ 07921, USA, NDC 623…
FDA Drug · Class III · 2023-08-23 · Alembic Pharmaceuticals
Reason: Failed Impurities/Degradation Specifications - Diclofenac Sodium Topical Solution USP, 2% w/w, 3.8 FL.OZ.(112 grams) bottles, Rx only, Manufactured for: Alembic Pharmaceuticals, Inc
FDA Drug · Class II · 2023-08-02 · Alembic Pharmaceuticals
Reason: Defective Delivery System - Telmisartan Tablets, USP 20 mg, 30-count bottles, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division) Panelav…
FDA Drug · Class I · 2021-04-14 · Alembic Pharmaceuticals
Reason: Labeling: Label-mixup - Aripiprazole Tablets, USP, 2 mg, 30 Tablets per bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division) Pa…
FDA Drug · Class II · 2020-07-01 · Alembic Pharmaceuticals
Reason: Labeling: Label mix up: Bottles labeled as aripiprazole 2 mg, 30 count had aripiprazole 5 mg tablets, 100 count.