Alembic Pharmaceuticals Inc.

• DoxycyclineDoxy 100, Acticlate Cap, Doryx Mpc · 14 products
• LamotrigineLamictal, Lamictal XR, Subvenite · 13 products
• Ropinirole12 products
• Pramipexole dihydrochloride12 products
• DiltiazemTiadylt ER, Cartia Xt, Tiazac Extended Release · 12 products
• Amlodipine and atorvastatinCaduet · 11 products
• FenofibrateAntara, Lipofen, Tricor · 11 products
• PregabalinLyrica, Lyrica CR · 8 products
• Venlafaxine hydrochlorideEffexor XR · 8 products
• AripiprazoleAbilify, Opipza, Abilify Asimtufii · 8 products
• Desipramine hydrochlorideNorpramin · 6 products
• DeferasiroxJadenu, Deferasorox, Exjade · 6 products
• Clobetasol propionateClobetasol Propionate (Emollient), Byqlovi, Tovet (Emollient Formulation) · 6 products
• Carbidopa, levodopa and entacapone6 products
• DasatinibSprycel, Phyrago · 6 products
• Chlorpromazine hydrochloride5 products
• FluoxetineProzac · 5 products
• ClonazepamKlonopin · 5 products
• Vardenafil5 products
• Lurasidone hydrochlorideLatuda · 5 products
• Doxepin hydrochlorideSilenor, Prudoxin, Zonalon · 5 products
• Valsartan and hydrochlorothiazideDiovan Hct · 5 products
• MetronidazoleMetronidazole Vaginal, Metronidazole Vaginal Gel, Likmez · 4 products
• ValsartanDiovan · 4 products
• ZolmitriptanZolmitriptan Od, Zolmiptriptan, Zomig · 4 products
• Telmisartan and amlodipine4 products
• Oseltamivir phosphateTamiflu · 4 products
• CarbamazepineTegretol XR, Equetro, Carbatrol · 4 products
• GuanfacineIntuniv · 4 products
• PaliperidoneInvega · 4 products
• Lithium carbonateLithobid · 4 products
• ClonidineClonidine Transdermal System, Catapres-Tts-1, Clonidine Transdermal System Usp, 0.1 Mg/Day · 4 products
• Amlodipine and valsartanExforge · 4 products
• TemazepamRestoril · 4 products
• LacosamideVimpat, Motpoly XR · 4 products
• TadalafilCialis, Tadliq, Adcirca · 4 products
• TreprostinilTyvaso Dpi, Remodulin, Orenitram · 4 products
• RivastigmineRivastigmine Transdermal System, Exelon · 4 products
• Amlodipine and olmesartan medoxomilAzor · 4 products
• Candesartan cilexetilAtacand · 4 products

• NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
• ANDA: Abbreviated New Drug Application: how a generic version is approved.

Showing the 125 newest of 214 applications. Full lists: Drugs@FDA →

The sponsor is the company that holds the FDA application; it can differ from the labeler.

2025

1. December 16, 2025 · Class III · Ongoing · D-0248-2026 · Fesoterodine fumarate

   Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.

   Fesoterodine Fumarate, Extended-release Tablets, 8 mg, 30 Tablets, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, N

2. October 10, 2025 · Class III · Ongoing · D-0156-2026 · Fesoterodine fumarate

   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 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminst

3. July 25, 2025 · Class II · Ongoing · D-0566-2025 · Doxepin hydrochloride

   CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.

   Doxepin Hydrochloride Capsules, USP, 10 mg, 100 Capsules, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panela v 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921,

4. May 9, 2025 · Class II · Ongoing · D-0459-2025 · Celecoxib

   Presence of Foreign Tablets/Capsules; customer complaint found one Tadalafil 5mg tablet inside a sealed 500-count bottle of Celecoxib 200mg capsule

   Celecoxib Capsules, 200 mg, 500-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division), Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster,

5. May 7, 2025 · Class II · Ongoing · D-0447-2025 · Bromfenac

   Failed Impurities/Degradation Specifications

   Bromfenac Ophthalmic Solution 0.09%, 1.7 mL bottle, Rx only, Sterile, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, Manufactured by Alembic Pharmaceuticals Limitied, Gujarat, India, Made in

2023

1. July 27, 2023 · Class III · Ongoing · D-1086-2023 · Tobramycin

   Failed Impurities/Degradation Specifications

   Tobramycin Opthalmic Solution USP, 0.3%, 5mL bottle, Rx only, Manufactured for: Alembic Pharmaceuticals, Bedminster, NJ 07921, USA, NDC 62332-518-05

2. June 22, 2023 · Class II · Ongoing · D-0941-2023 · Diclofenac

   Defective Delivery System

   Diclofenac Sodium Topical Solution USP, 2% w/w, 3.8 FL.OZ.(112 grams) bottles, Rx only, Manufactured for: Alembic Pharmaceuticals, Inc. Bedminster, NJ 07921, USA Manufactured by: Alembic Pharmaceuticals Limited (Derma Di

2021

1. March 17, 2021 · Class I · Terminated · D-0326-2021 · Telmisartan

   Labeling: Label-mixup

   Telmisartan Tablets, USP 20 mg, 30-count bottles, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division) Panelav 38935, Gujarat, India Manufactured for: Alembic Pharmaceuticals, Inc. 750 Route 2

2. March 15, 2021 · Class II · Terminated · D-0413-2021 · Bromfenac

   CGMP Deviations: Intermittent exposure to temperature excursion during storage.

   BROMFENAC OPHTHALMIC SOLUTION 0.09% 1.7ML NDC/UPC 62332-508-17; RX; DROPS

3. March 15, 2021 · Class II · Terminated · D-0412-2021 · Metoprolol tartrate and hydrochlorothiazide

   CGMP Deviations: Intermittent exposure to temperature excursion during storage.

   Metoprolol Tartrate and Hydrochlorothiazide Tablets, USP 50 mg/25 mg 100 Tablets Rx only NDC 62332-115-31 Manufactured for: Alembic Pharmaceuticals, Inc. 750 Route 202, Bridgewater, NJ 08807 USA

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1. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
2. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
3. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026

FDA Enforcement Report search → · Report an error →