Rising Pharma Holdings, Inc.

• Venlafaxine hydrochlorideEffexor XR · 9 products
• PregabalinLyrica, Lyrica CR · 8 products
• QuetiapineSeroquel, Seroquel XR · 7 products
• MirtazapineRemeronsoltab, Remeron · 7 products
• AtomoxetineStrattera, Atoncy · 7 products
• OxybutyninOxytrol · 7 products
• Amitriptyline hydrochloride6 products
• Carbidopa, levodopa and entacapone6 products
• AmoxicillinAmoxil · 6 products
• Amlodipine besylate and benazepril hydrochloride6 products
• FluconazoleDiflucan · 6 products
• TemozolomideTemodar · 6 products
• Pramipexole dihydrochloride6 products
• Albuterol sulfateVentolin HFA, Albuterol Sulate HFA, Proair Respiclick · 6 products
• Doxepin hydrochlorideSilenor, Prudoxin, Zonalon · 5 products
• BuspironeBucapsol · 5 products
• GabapentinNeurontin, Gralise, Relgaabi · 5 products
• Cyclobenzaprine hydrochlorideAmrix, Tonmya, Fexmid · 5 products
• TimololTimoptic in Ocudose, Timoptic-Xe, Timoptic · 5 products
• Tramadol hydrochlorideConzip · 4 products
• Cefprozil4 products
• TorsemideSoaanz · 4 products
• Ramipril4 products
• Perphenazine4 products
• ChlorthalidoneThalitone, Hemiclor · 4 products
• Trazodone hydrochlorideRaldesy Tm · 4 products
• MontelukastSingulair · 4 products
• AtorvastatinLipitor · 4 products
• DoxazosinCardura, Cardura XL · 4 products
• Memantine hydrochloride4 products
• Rizatriptan benzoateRizafilm, Maxalt-Mlt, Maxalt · 4 products
• RosuvastatinCrestor · 4 products
• LevetiracetamKeppra, Spritam, Keppra XR · 4 products
• Enalapril maleateVasotec, Epaned · 4 products
• EscitalopramLexapro · 4 products
• Captopril and hydrochlorothiazide4 products
• Chlorzoxazone4 products
• Meclizine hydrochloride4 products
• Fluphenazine hydrochlorideFluphenazine Hydrochoride · 4 products
• Ondansetron4 products
• Hydroxyzine3 products
• Carbidopa and levodopaCrexont, Rytary, Sinemet · 3 products
• DiclofenacZipsor, Lofena, Cambia · 3 products
• AllopurinolAloprim · 3 products
• Glyburide and metformin hydrochloride3 products
• Galantamine3 products
• Flecainide acetate3 products
• Trandolapril3 products
• FelodipineFelopdipine · 3 products
• PioglitazoneActos · 3 products
• GlipizideGlucotrol XL · 3 products
• Fluocinolone acetonideFluocinolone Acetonide Oil, Derma-Smoothe/Fs, Synalar · 3 products
• Famciclovir3 products
• SpironolactoneAldactone · 3 products
• FamotidinePepcid · 3 products
• BumetanideBumex, Enbumyst · 3 products
• Propafenone hydrochloride3 products
• Divalproex sodiumDepakote, Depakote ER, Depakote Sprinkles · 3 products
• MetoprololToprol XL, Lopressor, Kapspargo · 3 products
• Repaglinide3 products
• OmeprazolePrilosec · 3 products
• Midodrine hydrochloride3 products
• LorazepamAtivan, Loreev XR · 3 products
• Olmesartan medoxomilBenicar · 3 products
• CarbamazepineTegretol XR, Equetro, Carbatrol · 3 products
• Clomipramine hydrochlorideAnafranil · 3 products
• Cefadroxil3 products
• Alendronate sodiumBinosto, Fosamax · 3 products
• AtenololTenormin · 3 products
• FurosemideLasix, Furoscix, Lasix Onyu · 3 products
• Mexiletine hydrochloride3 products
• CiprofloxacinCiprofloxacin in Dextrose, Cipro, Ciloxan · 3 products
• Glimepiride3 products
• AmlodipineNorvasc, Sdamlo, Norliqva · 3 products
• BaclofenGablofen, Lyvispah, Baclofen (Intrathecal) · 3 products
• Fenoprofen calciumFenopron Tm · 3 products
• MethylphenidateMetadate Cd, Relexxii, Methylphenidate Hydrochloride Cd · 3 products
• SumatriptanImitrex, Tosymra, Zembrace Symtouch · 3 products
• Tolterodine tartrateDetrol · 2 products
• Dicyclomine hydrochloride2 products
• GlycopyrrolateGlyrx-Pf, Glycate, Cuvposa · 2 products
• LevocarnitineCarnitor, Carnitor Sf · 2 products
• Darifenacin2 products
• Donepezil hydrochlorideAricept · 2 products
• Potassium chlorideKlor-Con, Klor-Con M, Pokonza · 2 products
• Indapamide2 products
• Methimazole2 products
• TinidazoleTindazole, Tindamax · 2 products
• OfloxacinOcuflox · 2 products
• BudesonidePulmicort Flexhaler, Pulmicort Respules, Uceris · 2 products
• Bisoprolol fumarate2 products
• Clarithromycin2 products
• Cefuroxime axetil2 products
• EsomeprazoleNexium · 2 products
• RasagilineAzilect · 2 products
• ZolmitriptanZolmitriptan Od, Zolmiptriptan, Zomig · 2 products
• Potassium citrateUrocit-K · 2 products
• Lithium carbonateLithobid · 2 products
• DapsoneAczone · 2 products
• Methyldopa2 products
• AzithromycinZithromax, Azasite · 2 products
• LamotrigineLamictal, Lamictal XR, Subvenite · 2 products
• Ranitidine2 products
• ValacyclovirValtrex · 2 products
• FinasteridePropecia, Proscar · 2 products
• Pioglitazone and metformin hydrochlorideActoplus Met · 2 products
• Sulfamethoxazole and trimethoprimSulfamethoxazole and Trimethoprim Ds, Sulfatrim, Bactrim Ds · 2 products
• Zaleplon2 products
• Benzonatate2 products
• MetronidazoleMetronidazole Vaginal, Metronidazole Vaginal Gel, Likmez · 2 products
• CarisoprodolSoma · 2 products
• BupropionWellbutrin SR, Aplenzin, Wellbutrin XL · 2 products
• Aminocaproic acid2 products
• Nateglinide2 products
• TrientineSyprine, Cuvrior · 2 products
• Nitrofurantoin2 products
• Chloroquine phosphate2 products
• Pyridostigmine bromideMestinon, Pryidostigmine Bromide, Regonol · 2 products
• MesalaminePentasa, Lialda, Mesalamine Rectal · 2 products
• TizanidineZanaflex, Ontralfy · 2 products
• Pantoprazole sodiumProtonix I.V., Protonix Delayed-Release, Pantoprazole Sodium I.V. · 2 products
• EplerenoneInspra · 2 products
• Chlorhexidine gluconatePeriogard Alcohol Free, Dash Chlorhexidine Gluconate 0.12% Oral Rinse, Chlorhexidine Gluconate 0.12% Oral Rinse · 2 products
• Cyproheptadine2 products
• ModafinilProvigil · 2 products
• Cefpodoxime proxetil2 products
• Mycophenolate mofetilCellcept, Myhibbin · 1 product
• Diflorasone diacetatePsorcon · 1 product
• Erythromycin and benzoyl peroxide1 product
• LactuloseKristalose, Lactulose Crystalline, Enulose · 1 product
• Hydroxychloroquine sulfatePlaquenil, Sovuna · 1 product
• SulfasalazineAzulfidine, Azulfidine En-Tabs · 1 product
• ClotrimazoleClotic (Clotrimazole) Otic Solution · 1 product
• Calcium acetate1 product
• Alfuzosin hydrochlorideUroxatral · 1 product
• Abiraterone acetateZytiga, Abirtega, Yonsa · 1 product
• CalcitriolVectical · 1 product
• Clomiphene citrateClomid, Milophene · 1 product
• PentoxifyllineTrental · 1 product
• Sertraline hydrochlorideZoloft · 1 product
• ClopidogrelPlavix · 1 product
• DichlorphenamideOrmalvi, Keveyis · 1 product
• ClindamycinCleocin Phosphate, Cleocin Hydrochloride, Clindamycin Phoaphate Topical Solution Usp, 1% · 1 product
• SelegilineEmsam, Zelapar · 1 product
• AmantadineGocovri · 1 product
• Phenoxybenzamine hydrochloride1 product
• HydrocortisoneSolu-Cortef, Proctozone-Hc, Alkindi Sprinkle · 1 product
• Toremifene citrateFareston · 1 product
• Norepinephrine bitartrateLevophed · 1 product
• Ipratropium bromideAtrovent HFA · 1 product
• Ipratropium bromide and albuterol sulfateCombivent Respimat · 1 product
• Mafenide acetateSulfamylon · 1 product
• Methylergonovine maleateMethergine · 1 product
• Probenecid1 product
• Probenecid and colchicine1 product
• Triamcinolone acetonideKenalog-40, Triderm, Triesence · 1 product
• AzathioprineImuran, Azasan · 1 product
• HydrochlorothiazideInzirqo · 1 product
• ZileutonZyflo · 1 product
• AbacavirZiagen · 1 product
• Entacapone1 product
• Tamsulosin hydrochloride1 product
• LinezolidZyvox · 1 product
• Water-miscible retinyl palmitateAquasol a Parenteral · 1 product
• ItraconazoleTolsura, Sporanox · 1 product
• SirolimusHyftor, Fyarro · 1 product
• Cefdinir1 product
• MoxifloxacinVigamox · 1 product
• LamivudineEpivir · 1 product
• FingolimodGilenya · 1 product
• DexamethasoneTaperdex 6-Day, Hemady, Taperdex 12-Day · 1 product
• Clindamycin palmitate hydrochlorideClindamycin Palmitate Hydrochloride (Pediatric), Cleocin Pediatric · 1 product
• LatanoprostIyuzeh, Xalatan, Xelpros · 1 product
• PhenytoinDilantin, Phenytek, Phenytoin Infatabs · 1 product
• CetirizineQuzyttir, Zerviate · 1 product
• Cromolyn sodiumGastrocrom · 1 product
• Cevimeline hydrochlorideEvoxac · 1 product
• GemfibrozilLopid · 1 product
• Folic acidQuiofic · 1 product
• Cefixime1 product
• Neomycin sulfate, polymyxin b sulfate and hydrocortisoneNeomycin and Polymyxin B Sulfates and Hydrocortisone, Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension, Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic · 1 product
• Nitazoxanide1 product
• Edetate calcium disodium1 product

• NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
• 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 3, 2026 · Class II · Ongoing · D-0852-2026 · Chlorthalidone

   Failed Dissolution Specifications

   Chlorthalidone Tablets, USP, 25 mg, 100 Tablets per bottle, Rx only, Manufactured by: Inventia Healthcare Limited. NDC: 64980-599-01

2. July 13, 2026 · Class II · Ongoing · D-0724-2026 · Cyproheptadine

   Presence of Precipitate: medication was crystallizing and particles floating in the bottle

   Rising, Cyproheptadine Hydrochloride Syrup, 2mg/5 mL, 473 mL (ONE PINT), Rx only, Manufactured for: Rising Pharma Holdings, Inc., East Brunswick, NJ, Manufactured by: Lyne Laboratories, Inc., Brockton, MA. NDC 64980-504-

3. June 5, 2026 · Class II · Ongoing · D-0610-2026 · Chlorthalidone

   Failed Dissolution Specifications

   Chlorthalidone Tablets, USP, 25 mg, [100 or 1000] Tablets pr bottle, Rx only, Manufactured by: Inventia Healthcare Limited, Additional Ambernath, M.I.D.C., Ambernath (East) - 421506, INDIA. Distributed by: Risiong Pharma

4. April 23, 2026 · Class II · Ongoing · D-0520-2026 · Enalapril maleate

   Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test

   Enalapril Maleate Tablets, USP, 20 mg, 1,000-count bottle, Rx only, Manufactured by: Unique Pharmaceutical Laboratories (A Div. of J.B. Chemicals & Pharmaceuticals Ltd.), Mumbai 400 030, India, Distributed by: Rising Pha

5. March 3, 2026 · Class II · Ongoing · D-0384-2026 · Temozolomide

   Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing

   Product label: Temozolomide Capsules, 5mg, packaged in 5-capsule bottles, Rx only, Manufactured for: Rising Pharmaceuticals, Inc., Allendale, NJ 07401, Country of origin: Taiwan, NDC 16571-816-51.

6. January 10, 2026 · Class II · Ongoing · D-0293-2026 · Furosemide

   Presence of Foreign Substance

   Furosemide Tablets, USP 40 mg, 1,000 Tablets, Rx Only, Manufactured for: Rising Pharmaceuticals Inc., East Brunswick, NJ 08816, Manufactured by: Graviti Pharmaceuticals Pvt. Ltd. Telangana - 502307, India, NDC 64980-563-

2025

1. October 7, 2025 · Class II · Ongoing · D-0029-2026 · Carbidopa, levodopa and entacapone

   Product mix up: complaint received that sealed medication bottle contained Carbidopa, Levodopa, and Entacapone film-coated tablets (37.5 mg/150 mg/200 mg) instead of labelled lower strength Carbidopa, Levodopa, and Entacapone film-coated tablets (25 mg/100 mg/200 mg).

   Carbidopa, Levodopa, Entacapone Tablets, 25 mg/100 mg/200 mg, 100-count bottle, Rx Only, Manufactured for: Rising Pharma Holdings, Inc. East Brunswick, NJ, 08816, Manufactured by Suven Pharmaceuticals Limited, Pashamylar

2. September 15, 2025 · Class II · Ongoing · D-0037-2026 · Bupropion

   Failed Tablet/Capsule Specifications

   Bupropion Hydrochloride Extended-Release Tablets USP (XL), 300 mg, 30-count bottles, Rx Only, Mfd. by: Graviti Pharmaceuticals Private Limited, Sangareddy, Telangana, India, Dist. by: Rising Phar, NDC 16571-863-03.

3. July 5, 2025 · Class II · Ongoing · D-0543-2025 · Timolol

   Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle.

   Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-514-05.

4. April 18, 2025 · Class II · Ongoing · D-0403-2025 · Timolol

   Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.

   Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 10mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-514-01

5. January 23, 2025 · Class II · Ongoing · D-0214-2025 · Timolol

   Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.

   Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-514-05.

2024

1. December 5, 2024 · Class II · Ongoing · D-0114-2025 · Timolol

   Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.

   Timolol Maleate Ophthalmic Solution USP, 0.25%, Sterile, 15mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-513-1

2. October 29, 2024 · Class II · Ongoing · D-0035-2025 · Timolol

   Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle

   Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-514-05.

3. August 12, 2024 · Class II · Ongoing · D-0642-2024 · Timolol

   Defective Container: patients are unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.

   Timolol Maleate Ophthalmic Solution USP, 0.5%, packaged in: a) 5mL bottle (NDC 64980-514-05), and b) 10mL bottle (NDC 64980-514-01), Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, India, Distributed by: Rising

4. July 18, 2024 · Class II · Ongoing · D-0632-2024 · Timolol

   Defective container; yellow colored spike from cap lodged in the nozzle

   Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, [NDC 64980-514-05

5. June 24, 2024 · Class III · Ongoing · D-0599-2024 · Diflorasone diacetate

   Failed Impurities/Degradation Specifications: The impurity results at 12 months stability testing,did not conform to the specification limit.

   Diflorasone Diacetate Ointment, USP, 0.05%, 60g tube, Rx only, Mfd. By: Lyne Laboratories, Inc., Brockton, MA 02301; Mfd. For: Rising Pharmaceuticals, Inc., East Brunswick, NJ 08816 NDC 64980-124-60

6. May 16, 2024 · Class III · Ongoing · D-0541-2024 · Pregabalin

   Presence of Foreign Tablets/Capsules: Complaint received from a re-packager, American Health Packaging (AHP), where a foreign tablet was discovered in one of the bottles during packaging set up. Tablet identified as pantoprazole tablet 20mg.

   Pregabalin Capsules 50mg, 1000-count bottle, Rx Only, Manufactured for: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, Manufactured by: Laurus Labs Limited, Anakapalli-531011, India, NDC 64980-411-10

7. April 25, 2024 · Class II · Terminated · D-0488-2024 · Timolol

   Defective Container: yellow-colored spike from cap lodged in the nozzle. Firm received several complaints from customers.

   Timolol Maleate Ophthalmic Solution, USP, 0.5%, packaged in a) 5mL bottles (NDC 64980-514-05), and b) 15 mL bottles (NDC 64980-514-15), Rx only, Manufactured by: FDC Limited, Maharashtra, India, Distributed by: Rising Ph

2023

1. December 29, 2023 · Class II · Ongoing · D-0222-2024 · Bupropion

   Presence of Foreign Tablets/Capsules

   buPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150mg, 30-count bottles, Rx Only, Manufactured for: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816 Manufactured by: Graviti Pharmaceuticals Pvt. Ltd. Tela

2022

1. February 7, 2022 · Class II · Ongoing · D-0573-2022 · Methylphenidate

   Failed Tablet Specifications: Recall of this drug product was voluntarily initiated by the manufacturer due to a market complaint, which stated that a tablet in the sealed bottle was twice larger in size when compared to the remaining tablets. This complaint is second of its kind.

   Methylphenidate Hydrochloride Chewable Tablets, 2.5 mg, 100-count bottle, Rx Only, Manufactured for: Rising Pharmaceuticals Inc., Saddle Brook, NJ 07863, NDC 64980-221-01

2019

1. November 15, 2019 · Class III · Terminated · D-1367-2020 · Timolol

   Labeling: Label mix-up: A case of Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml, had the outer carton for Timolol Maleate Sterile Ophthalmic solution USP 0.5%, 5ml but the bottle inside was Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml.

   Timolol Maleate USP, 0.5%, 5 mL, Sterile Opthalmic Solution, Rx Only, For Topical Application in the Eye, Distributed by: Rising Pharmaceuticals, Inc. Saddle Brook, NJ 07663, Manufactured by: FDC Limited B-8, MIDC Indust

2. November 15, 2019 · Class III · Terminated · D-1368-2020 · Timolol

   Labeling: Label mix-up: A case of Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml, had the outer carton for Timolol Maleate Sterile Ophthalmic solution USP 0.5%, 5ml but the bottle inside was Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml.

   Timolol Maleate Sterile Opthalmic Solution,USP 0.25%, 5 mL, Rx Only, For Topical Application, Distributed by: Rising Pharmaceuticals, Inc. Saddle Brook, NJ 07863, Manufactured by: FDC Limited B-8, MDC Industrial Area, Wa

2018

1. April 13, 2018 · Class II · Terminated · D-0712-2018 · Fluocinolone acetonide

   Subpotent Drug

   Fluocinolone Acetonide Topical Oil, 0.01% (Ear Drops) 20 mL, Rx Only, Manufactured by: Lyne Laboratories, Inc. Brockton, MA 02307 Manufactured for: Rising Pharmaceuticals, Inc. Allendale, NJ 07401, NDC 64980-329-20, UPC

2. April 13, 2018 · Class II · Terminated · D-0711-2018 · Fluocinolone acetonide

   Subpotent Drug

   Fluocinolone Acetonide Topical Oil, 0.01% (Body Oil) 118.28 mL (4 fl. oz.) Rx Only, Manufactured by: Lyne Laboratories, Inc. Brockton, MA 02307 Manufactured for: Rising Pharmaceuticals, Inc. Allendale, NJ 07401, NDC 6498

3. April 13, 2018 · Class II · Terminated · D-0713-2018 · Fluocinolone acetonide

   Subpotent Drug

   Fluocinolone Acetonide Topical Oil, 0.01% (Scalp Oil) 118.28 mL (4 fl.oz.) Rx Only, Manufactured by: Lyne Laboratories, Inc. Brockton, MA 02307 Manufactured for: Rising Pharmaceuticals, Inc. Allendale, NJ 07401, NDC 6498

2012

1. March 9, 2012 · Class III · Terminated · D-1422-2012 · Ciprofloxacin

   Labeling Illegible: Missing Label; The voluntary recall of the aforementioned batch of product is being initiated due to two bottles missing container labels.

   Ciprofloxacin Tablets, USP, 500 mg, Rx Only, 100 Tablets per Bottle, Manufactured in India by: Unique Pharmaceutical Laboratories (A Division of J.B. Chemicals & Pharmaceuticals Ltd.), Mumbai - 400 030, Distributed by: P

What do the recall classes mean?

Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).

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 →