Epic Pharma, LLC

• BuspironeBucapsol · 12 products
• BupropionWellbutrin SR, Aplenzin, Wellbutrin XL · 11 products
• Metformin hydrochlorideGlumetza · 7 products
• CholestyramineQuestran, Prevalite, Cholestyramine Light · 6 products
• Oxycodone hydrochlorideOxycontin, Roxybond, Roxicodone · 5 products
• GabapentinNeurontin, Gralise, Relgaabi · 5 products
• Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfateAdderall, Mixed Salts of a Single Entity Amphetamine Product XR, Adderall XR · 5 products
• Doxepin hydrochlorideSilenor, Prudoxin, Zonalon · 5 products
• Chlordiazepoxide hydrochloride5 products
• Oseltamivir phosphateTamiflu · 4 products
• EntecavirBaraclude · 4 products
• MetoprololToprol XL, Lopressor, Kapspargo · 4 products
• CelecoxibCelebrex, Vyscoxa, Elyxyb - Celecoxib · 4 products
• AzithromycinZithromax, Azasite · 4 products
• Leucovorin calciumVykoura · 4 products
• AmlodipineNorvasc, Sdamlo, Norliqva · 3 products
• EstradiolEstradiol Vaginal, Dotti, Estradiol Transdermal System · 3 products
• NystatinNystop, Klayesta, Nyamyc · 3 products
• Oxazepam3 products
• Tapentadol hydrochlorideNucynta ER, Nucynta · 3 products
• Flecainide acetate3 products
• Sotalol hydrochlorideBetapace, Sotalol Hydrochloride Af, Betapace Af · 3 products
• Hydroxyzine3 products
• Venlafaxine hydrochlorideEffexor XR · 3 products
• Trandolapril3 products
• Oxycodone and acetaminophenEndocet, Prolate, Percocet · 3 products
• Molindone hydrochloride3 products
• DeferasiroxJadenu, Deferasorox, Exjade · 3 products
• CitalopramCelexa · 3 products
• Icosapent ethylVascepa · 3 products
• CyclophosphamideFrindovyx · 3 products
• Hydrocodone bitartrate and acetaminophenNorco · 3 products
• CarbamazepineTegretol XR, Equetro, Carbatrol · 3 products
• Potassium chlorideKlor-Con, Klor-Con M, Pokonza · 3 products
• LabetalolLabetalol HCL in Dextrose · 3 products
• Sulindac2 products
• Meperidine hydrochlorideDemerol · 2 products
• NicardipineCardene IV · 2 products
• NintedanibOfev · 2 products
• Protriptyline hydrochloride2 products
• Ethambutol hydrochloride2 products
• Demeclocycline2 products
• Nizatidine2 products
• Benzonatate2 products
• CalcitriolVectical · 2 products
• Betaxolol hydrochlorideBetoptic S · 2 products
• Methadone hydrochlorideMethadone Hydrocloride Dye-Free, Sugar-Free, Unflavored, Methadose, Methadose Sugar-Free · 2 products
• Quinidine2 products
• Rifampin2 products
• AmphetamineAdzenys Xr-Odt, Dyanavel XR, Evekeo · 2 products
• GuanfacineIntuniv · 2 products
• EthosuximideZarontin · 2 products
• Oxymorphone hydrochloride2 products
• Meclizine hydrochloride2 products
• DoxycyclineDoxy 100, Acticlate Cap, Doryx Mpc · 2 products
• OxcarbazepineTrileptal, Oxtellar XR · 1 product
• Sodium polystyrene sulfonateKionex · 1 product
• IvermectinStromectol, Soolantra · 1 product
• OMEGA-3-ACID ethyl estersOmega-3-Acid Ethyl Ester · 1 product
• Flavoxate hydrochloride1 product
• Oxycodone and aspirin1 product
• MethylprednisoloneSolu-Medrol, Medrol · 1 product
• UrsodiolReltone 200 Mg, Ursolign, Urso Forte · 1 product
• Phentermine hydrochlorideLomaira · 1 product
• ErgocalciferolVitamin D · 1 product
• Benzphetamine hydrochloride1 product
• Dutasteride1 product
• AmantadineGocovri · 1 product
• Sulfadiazine1 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.

2021

1. March 15, 2021 · Class II · Terminated · D-0582-2021 · Sulindac

   CGMP Deviations: Intermittent exposure to temperature excursion during storage.

   Sulindac Tablets, USP, 200mg 100-count bottles, Rx Only, Manufactured by: Epic Pharma, LLC, Laurelton, NY 11413, NDC 42806-011-01

2019

1. September 26, 2019 · Class II · Terminated · D-0135-2020 · Estradiol

   Presence of Foreign Tablets/Capsules: Estradiol 1 mg was found in a 100 count bottle of Estradiol 0.5 mg Tablets.

   Estradiol tablets, 0.5 mg, 100-count bottles, Rx only, Distributed by Epic Pharma, LLC Laurelton, NY 11413, NDC 42806-087-01

2018

1. December 4, 2018 · Class II · Terminated · D-0297-2019 · Estradiol

   Presence of foreign tablet/capsule: A single foreign tablet was found in pharmacy dispensed bottle of 30 Estradiol 2 mg tablets.

   Estradiol Tablets, USP, 2 mg, 100-count bottle, Rx Only, Distributed by: Epic Pharma, LLC Laurelton, NY 11413, NDC 42806-089-01

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

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