Ajanta Pharma USA Inc.

• TopiramateTopamax, Qudexy XR, Trokendi XR · 9 products
• Doxepin hydrochlorideSilenor, Prudoxin, Zonalon · 7 products
• RisperidoneUzedy, Risperdal, Risperdal M-Tab · 6 products
• BrexpiprazoleRexulti · 6 products
• AripiprazoleAbilify, Opipza, Abilify Asimtufii · 6 products
• Haloperidol6 products
• FenofibrateAntara, Lipofen, Tricor · 5 products
• SildenafilViagra, Vybrique, Revatio · 5 products
• TadalafilCialis, Tadliq, Adcirca · 5 products
• Omeprazole and sodium bicarbonateZegerid · 4 products
• LamotrigineLamictal, Lamictal XR, Subvenite · 4 products
• Venlafaxine hydrochlorideEffexor XR · 4 products
• Fluphenazine hydrochlorideFluphenazine Hydrochoride · 4 products
• Terazosin hydrochlorideTezruly · 4 products
• DoxycyclineDoxy 100, Acticlate Cap, Doryx Mpc · 4 products
• Metformin hydrochlorideGlumetza · 4 products
• Captopril4 products
• DuloxetineDrizalma Sprinkle · 4 products
• Amlodipine and olmesartan medoxomilAzor · 4 products
• MontelukastSingulair · 4 products
• PaliperidoneInvega · 4 products
• OxybutyninOxytrol · 3 products
• CarbamazepineTegretol XR, Equetro, Carbatrol · 3 products
• OxcarbazepineTrileptal, Oxtellar XR · 3 products
• Clomipramine hydrochlorideAnafranil · 3 products
• Acetazolamide2 products
• TetrabenazineXenazine · 2 products
• Tolterodine tartrateDetrol · 2 products
• Methazolamide2 products
• TheophyllineTheo-24 · 2 products
• ProchlorperazineCompro · 2 products
• Metoprolol tartrate and hydrochlorothiazide2 products
• Memantine hydrochloride2 products
• Varenicline tartrateChantix, Tyrvaya · 2 products
• Solifenacin succinate2 products
• RanolazineAspruzyo Sprinkle · 2 products
• ValganciclovirValcyte · 2 products
• GuanfacineIntuniv · 2 products
• Ranitidine2 products
• ChlorthalidoneThalitone, Hemiclor · 2 products
• VoriconazoleVfend · 2 products
• Naproxen and esomeprazole magnesium2 products
• LansoprazolePrevacid Solutab, Prevacid · 2 products
• ZolmitriptanZolmitriptan Od, Zolmiptriptan, Zomig · 2 products
• Almotriptan2 products
• Silodosin2 products
• Fluvoxamine maleate2 products
• PrucaloprideMotegrity · 2 products
• DapagliflozinFarxiga · 2 products
• FamotidinePepcid · 1 product
• TofacitinibXeljanz, Xeljanz XR · 1 product
• CholestyramineQuestran, Prevalite, Cholestyramine Light · 1 product
• Entacapone1 product
• Pantoprazole sodiumProtonix I.V., Protonix Delayed-Release, Pantoprazole Sodium I.V. · 1 product
• IvermectinStromectol, Soolantra · 1 product
• Ketorolac tromethamineAcuvail, Sprix, Ketrolac Tromethamine · 1 product
• ClonidineClonidine Transdermal System, Catapres-Tts-1, Clonidine Transdermal System Usp, 0.1 Mg/Day · 1 product
• Divalproex sodiumDepakote, Depakote ER, Depakote Sprinkles · 1 product
• Oseltamivir phosphateTamiflu · 1 product

• ANDA: Abbreviated New Drug Application: how a generic version is approved.

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

2026

1. September 17, 2026 · Class II · Ongoing · D-0010-2027 · Ranolazine

   Failed Dissolution Specifications: below specification

   Ranolazine Extended-Release Tablets, 1000 mg, 60-count bottle, Rx Only, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807. NDC: 27241-126-02

2. August 25, 2026 · Class III · Ongoing · D-0836-2026 · Fluphenazine hydrochloride

   Failed impurities/degradation specifications: (OOS) for Organic Impurities by HPLC (Impurity-A) during testing at the 18 months long term stability. Result: 1.1 percent. Spec: 1.0 percent.

   Fluphenazine Hydrochloride Tablets, USP, 1mg, 100-count bottles, Rx Only, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-255-01.

3. May 28, 2026 · Class II · Ongoing · D-0611-2026 · Fenofibrate

   CGMP Deviations

   Fenofibrate Capsules, USP 200 mg, Rx only, 100 Capsules, Manufactured by: Ajanta Pharma Limited, India, Marketed by: Ajanta Pharma USA Inc. Bridgewater, NJ 08807, NDC 27241-120-04.

4. May 27, 2026 · Class II · Ongoing · D-0594-2026 · Aripiprazole

   Product Mix-Up: A bottle containing Voriconazole Tablets 50 mg was labelled and distributed as Aripiprazole Tablets USP 30 mg.

   Aripiprazole Tablets USP, Rx only, 30 mg, 30 tablets, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-056-03.

5. April 29, 2026 · Class II · Ongoing · D-0514-2026 · Duloxetine

   CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.

   Duloxetine Delayed-Release Capsules, 30 mg, Rx Only, a) 90 Capsules, NDC 27241-098-09, b) 30 capsules, NDC 27241-098-03, c) 1000 Capsules, NDC 27241-098-10, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Mad

6. April 29, 2026 · Class II · Ongoing · D-0516-2026 · Duloxetine

   CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.

   Duloxetine Delayed-Release Capsules, 20 mg, Rx Only, 60 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-097-06.

7. April 29, 2026 · Class II · Ongoing · D-0515-2026 · Duloxetine

   CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.

   Duloxetine Delayed-Release Capsules, 60 mg, Rx Only, 30 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-099-03

2021

1. March 15, 2021 · Class II · Terminated · D-0407-2021 · Fenofibrate

   CGMP Deviations: Intermittent exposure to temperature excursion during storage.

   FENOFIBRATE CAPSULES, UPS 67MG 100 CAPSULES NDC/UPC 27241-118-04; RX; CAPSULES

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 →