AvKARE
NDC labeler codes: 42291, 73190
What is a labeler?
The company whose name is on the package and in the FDA’s National Drug Code (NDC) Directory. It may make the medicine itself or sell medicine made by another company. The first part of every NDC code identifies the labeler.
Official FDA data only
Products, approvals and recalls come from the FDA (NDC Directory, Drugs@FDA, enforcement reports). Recalls are linked to this company by the NDC labeler code on the recalled product.
Questions about your medicine: ask your doctor or pharmacist. In an emergency, call 911.
Prescription medicines
- LamotrigineLamictal, Lamictal XR, Subvenite · 10 products
- AtomoxetineStrattera, Atoncy · 7 products
- Sacubitril and valsartanEntresto · 6 products
- Olmesartan medoxomil and hydrochlorothiazideBenicar Hct · 6 products
- Famciclovir6 products
- Lisdexamfetamine dimesylateVyvanse, Arynta · 6 products
- RisperidoneUzedy, Risperdal, Risperdal M-Tab · 6 products
- DasatinibSprycel, Phyrago · 6 products
- Ropinirole5 products
- Valsartan and hydrochlorothiazideDiovan Hct · 5 products
- TadalafilCialis, Tadliq, Adcirca · 5 products
- Olanzapine and fluoxetine5 products
- FenofibrateAntara, Lipofen, Tricor · 4 products
- Cephalexin4 products
- DiclofenacZipsor, Lofena, Cambia · 4 products
- TorsemideSoaanz · 4 products
- Terazosin hydrochlorideTezruly · 4 products
- PaliperidoneInvega · 4 products
- BrivaracetamBriviact · 4 products
- Potassium chlorideKlor-Con, Klor-Con M, Pokonza · 4 products
- Propranolol hydrochlorideInderal La, Inderal XL, Hemangeol · 4 products
- ProgesteroneCrinone, Prometrium, Endometrin · 4 products
- ValsartanDiovan · 4 products
- TopiramateTopamax, Qudexy XR, Trokendi XR · 4 products
- CarvedilolCoreg, Coreg CR · 4 products
- OxybutyninOxytrol · 4 products
- DeflazacortJaythari, Emflaza, Kymbee · 4 products
- NebivololBystolic · 4 products
- Amlodipine and olmesartan medoxomilAzor · 4 products
- Sunitinib malateSutent · 4 products
- EltrombopagPromacta · 4 products
- Captopril3 products
- TofacitinibXeljanz, Xeljanz XR · 3 products
- AzithromycinZithromax, Azasite · 3 products
- Acitretin3 products
- Telmisartan and hydrochlorothiazideMicardis Hct · 3 products
- Midodrine hydrochloride3 products
- Verapamil hydrochloride3 products
- Trazodone hydrochlorideRaldesy Tm · 3 products
- Venlafaxine hydrochlorideEffexor XR · 3 products
- DoxazosinCardura, Cardura XL · 3 products
- FurosemideLasix, Furoscix, Lasix Onyu · 3 products
- PirfenidoneEsbriet · 3 products
- Losartan potassium and hydrochlorothiazideHyzaar · 3 products
- Oseltamivir phosphateTamiflu · 3 products
- Mexiletine hydrochloride3 products
- Telmisartan3 products
- Vardenafil3 products
- IrbesartanAvapro · 3 products
- DiltiazemTiadylt ER, Cartia Xt, Tiazac Extended Release · 3 products
- PitavastatinZypitamag, Livalo · 3 products
- PioglitazoneActos · 3 products
- Carbidopa and levodopaCrexont, Rytary, Sinemet · 3 products
- AmlodipineNorvasc, Sdamlo, Norliqva · 3 products
- Tapentadol hydrochlorideNucynta ER, Nucynta · 3 products
- PrucaloprideMotegrity · 2 products
- AmantadineGocovri · 2 products
- NintedanibOfev · 2 products
- AzathioprineImuran, Azasan · 2 products
- Acetazolamide2 products
- Glipizide and metformin hydrochloride2 products
- EplerenoneInspra · 2 products
- Ondansetron2 products
- Sulfamethoxazole and trimethoprimSulfamethoxazole and Trimethoprim Ds, Sulfatrim, Bactrim Ds · 2 products
- UrsodiolReltone 200 Mg, Ursolign, Urso Forte · 2 products
- Metaxalone2 products
- Abiraterone acetateZytiga, Abirtega, Yonsa · 2 products
- Clobetasol propionateClobetasol Propionate (Emollient), Byqlovi, Tovet (Emollient Formulation) · 2 products
- Diclofenac sodium and misoprostolArthrotec, Dicloenac Sodium and Misoprostol DR · 2 products
- LeflunomideArava · 2 products
- PrimidoneMysoline · 2 products
- RanolazineAspruzyo Sprinkle · 2 products
- Silodosin2 products
- SucralfateCarafate · 2 products
- DapsoneAczone · 2 products
- RoflumilastZoryve, Daliresp · 2 products
- MontelukastSingulair · 2 products
- TeriflunomideAubagio · 2 products
- Piroxicam2 products
- TicagrelorBrilinta · 2 products
- DapagliflozinFarxiga · 2 products
- Methimazole2 products
- Dabigatran etexilatePradaxa · 2 products
- EstradiolEstradiol Vaginal, Dotti, Estradiol Transdermal System · 2 products
- EtravirineIntelence · 2 products
- Alosetron hydrochlorideLotronex · 2 products
- AnastrozoleArimidex · 2 products
- Benzonatate2 products
- Metformin hydrochlorideGlumetza · 2 products
- ValganciclovirValcyte · 2 products
- Varenicline tartrateChantix, Tyrvaya · 2 products
- ZolmitriptanZolmitriptan Od, Zolmiptriptan, Zomig · 2 products
- Mycophenolate mofetilCellcept, Myhibbin · 2 products
- MirtazapineRemeronsoltab, Remeron · 2 products
- Zafirlukast2 products
- Solifenacin succinate2 products
- NilotinibTasigna, Danziten, Cavhanza · 2 products
- Fluvoxamine maleate2 products
- LacosamideVimpat, Motpoly XR · 1 product
- Cefdinir1 product
- Butalbital, acetaminophen and caffeineFioricet · 1 product
- Lithium carbonateLithobid · 1 product
- MetoclopramideReglan, Gimoti · 1 product
- Tenofovir disoproxil fumarateViread · 1 product
- Azelastine hydrochloride1 product
- Etonogestrel and ethinyl estradiolNuvaring, Enilloring, Eluryng · 1 product
- DoxycyclineDoxy 100, Acticlate Cap, Doryx Mpc · 1 product
- Chloroquine phosphate1 product
- FingolimodGilenya · 1 product
- NystatinNystop, Klayesta, Nyamyc · 1 product
- Norelgestromin and ethinyl estradiolZafemy, Xulane, Gwyn Lo · 1 product
- Memantine and donepezilMemantine and Donepezil Hydrochlorides Extended-Release, Namzaric · 1 product
- Sevelamer carbonateRenvela · 1 product
- MesalaminePentasa, Lialda, Mesalamine Rectal · 1 product
- HydroxyureaDroxia, Hydrea, Siklos · 1 product
- LetrozoleFemara · 1 product
- Cilostazol1 product
- Primaquine phosphate1 product
- Norethindrone acetateGallifrey · 1 product
- RiluzoleTiglutik · 1 product
- Aspirin and extended-release dipyridamole1 product
- ErgocalciferolVitamin D · 1 product
- Fludrocortisone acetate1 product
- PosaconazoleNoxafil · 1 product
- TheophyllineTheo-24 · 1 product
- PazopanibVotrient · 1 product
- Emtricitabine and tenofovir disoproxil fumarateTruvada · 1 product
- Calcium acetate1 product
- AtovaquoneMepron · 1 product
- Acebutolol hydrochloride1 product
- Isradipine1 product
- EntecavirBaraclude · 1 product
- MethotrexateRasuvo, Otrexup, Trexall · 1 product
- RamelteonRozerem · 1 product
- SildenafilViagra, Vybrique, Revatio · 1 product
- BexaroteneTargretin · 1 product
- LidocaineXylocaine Mpf, Xylocaine, Lidocaine Viscous · 1 product
- TizanidineZanaflex, Ontralfy · 1 product
- DeferasiroxJadenu, Deferasorox, Exjade · 1 product
- LapatinibTykerb · 1 product
- Cyclobenzaprine hydrochlorideAmrix, Tonmya, Fexmid · 1 product
- Dutasteride1 product
- Minoxidil1 product
- Naltrexone hydrochloride1 product
- Tamsulosin hydrochloride1 product
- DeferiproneFerriprox · 1 product
FDA applications for these 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.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| September 3, 2026 | ANDA220865 | Tapentadol hydrochloride TAPENTADOL HYDROCHLORIDE | Msn |
| July 9, 2026 | ANDA212555 | Nintedanib NINTEDANIB ESYLATE | Glenmark Pharms Ltd |
| June 3, 2026 | ANDA217299 | Tofacitinib TOFACITINIB CITRATE | Msn |
| June 3, 2026 | ANDA220458 | Tofacitinib TOFACITINIB CITRATE | Apotex |
| April 6, 2026 | ANDA211478 | Dapagliflozin DAPAGLIFLOZIN | Msn |
| January 14, 2026 | ANDA212884 | Eltrombopag ELTROMBOPAG OLAMINE | Amneal |
| November 19, 2025 | ANDA218544 | Nilotinib NILOTINIB HYDROCHLORIDE | Msn |
| November 13, 2025 | ANDA214921 | Brivaracetam BRIVARACETAM | Msn |
| August 27, 2025 | ANDA211094 | Dasatinib DASATINIB | Teva Pharms USA |
| July 16, 2025 | ANDA213748 | Sacubitril and valsartan SACUBITRIL AND VALSARTAN | Msn |
| June 26, 2025 | ANDA219699 | Lacosamide LACOSAMIDE | Ajenat Pharms |
| June 24, 2025 | ANDA218977 | Prucalopride PRUCALOPRIDE SUCCINATE | Apotex |
| April 8, 2025 | ANDA219254 | Deflazacort JAYTHARI | Zydus Lifesciences |
| October 28, 2024 | ANDA218979 | Potassium chloride KLOR-CON | Twi Pharms |
| August 22, 2024 | ANDA213191 | Mesalamine MESALAMINE | Teva Pharms Inc |
| August 16, 2024 | ANDA217968 | Lapatinib LAPATINIB DITOSYLATE | Teva Pharms USA Inc |
| July 11, 2024 | ANDA217170 | Doxycycline DOXYCYCLINE | Apotex |
| May 28, 2024 | ANDA213605 | Sacubitril and valsartan SACUBITRIL AND VALSARTAN | Crystal |
| May 22, 2024 | ANDA213879 | Dabigatran etexilate DABIGATRAN ETEXILATE MESYLATE | Msn |
| October 19, 2023 | ANDA217517 | Pazopanib PAZOPANIB HYDROCHLORIDE | Teva Pharms Inc |
| August 25, 2023 | ANDA202830 | Lisdexamfetamine dimesylate LISDEXAMFETAMINE DIMESYLATE | Amneal |
| August 23, 2023 | ANDA214557 | Varenicline tartrate VARENICLINE TARTRATE | Alkem Labs Ltd |
| August 11, 2023 | ANDA204382 | Valsartan and hydrochlorothiazide VALSARTAN AND HYDROCHLOROTHIAZIDE | Amneal Pharms |
| June 29, 2023 | ANDA211157 | Etonogestrel and ethinyl estradiol ENILLORING | Xiromed |
| March 10, 2023 | ANDA206210 | Topiramate TOPIRAMATE | Actavis Labs Fl |
| December 22, 2022 | ANDA216626 | Posaconazole POSACONAZOLE | Amneal |
| November 29, 2022 | ANDA212506 | Diclofenac DICLOFENAC SODIUM | Alembic |
| August 11, 2022 | ANDA210608 | Tadalafil TADALAFIL | Prinston Inc |
| May 5, 2022 | ANDA215775 | Diltiazem DILTIAZEM HYDROCHLORIDE | DR Reddys Labs SA |
| April 15, 2022 | ANDA215576 | Sucralfate SUCRALFATE | Amneal Pharms |
| March 25, 2022 | ANDA212570 | Pirfenidone PIRFENIDONE | Amneal |
| January 3, 2022 | ANDA212569 | Pirfenidone PIRFENIDONE | Amneal |
| November 30, 2021 | ANDA213803 | Sunitinib malate SUNITINIB MALATE | Teva Pharms USA |
| October 25, 2021 | ANDA207842 | Eplerenone EPLERENONE | Everest Lifesciences |
| October 8, 2021 | ANDA215585 | Diclofenac DICLOFENAC POTASSIUM | Ingenus Pharms LLC |
| June 14, 2021 | ANDA214196 | Etravirine ETRAVIRINE | Amneal |
| February 25, 2021 | ANDA213950 | Norelgestromin and ethinyl estradiol ETHINYL ESTRADIOL AND NORELGESTROMIN | Amneal |
| December 17, 2020 | ANDA208165 | Oxybutynin OXYBUTYNIN CHLORIDE | Strides Pharma |
| August 24, 2020 | ANDA206463 | Lidocaine LIDOCAINE | Amneal |
| August 21, 2020 | ANDA213186 | Ramelteon RAMELTEON | Granules |
| July 2, 2020 | ANDA208008 | Fingolimod FINGOLIMOD HYDROCHLORIDE | Teva Pharms USA |
| April 7, 2020 | ANDA208596 | Ticagrelor TICAGRELOR | Msn |
| March 30, 2020 | ANDA208247 | Roflumilast ROFLUMILAST | Strides Pharma |
| March 23, 2020 | ANDA212781 | Ranolazine RANOLAZINE | Quagen |
| December 9, 2019 | ANDA206045 | Riluzole RILUZOLE | Kenton |
| December 2, 2019 | ANDA209356 | Sucralfate SUCRALFATE | Amneal |
| November 20, 2019 | ANDA210945 | Deferasirox DEFERASIROX | Msn |
| September 23, 2019 | ANDA204707 | Paliperidone PALIPERIDONE | Amneal Pharms |
| May 20, 2019 | ANDA210281 | Solifenacin succinate SOLIFENACIN SUCCINATE | Bostal |
| March 26, 2019 | ANDA209744 | Tadalafil TADALAFIL | Amneal Pharms Co |
| March 4, 2019 | ANDA202544 | Telmisartan and hydrochlorothiazide TELMISARTAN AND HYDROCHLOROTHIAZIDE | Glenmark Pharms Ltd |
| February 26, 2019 | ANDA210000 | Azithromycin AZITHROMYCIN | Bionpharma |
| February 26, 2019 | ANDA210001 | Azithromycin AZITHROMYCIN | Bionpharma |
| February 8, 2019 | ANDA208800 | Deferiprone DEFERIPRONE | Taro |
| January 7, 2019 | ANDA208327 | Abiraterone acetate ABIRATERONE ACETATE | Amneal Pharms |
| December 26, 2018 | ANDA211256 | Clobetasol propionate CLOBETASOL PROPIONATE | Amneal |
| December 3, 2018 | ANDA209010 | Amlodipine and olmesartan medoxomil AMLODIPINE AND OLMESARTAN MEDOXOMIL | Sciegen Pharms |
| December 3, 2018 | ANDA209745 | Silodosin SILODOSIN | Amneal Pharms Co |
| November 30, 2018 | ANDA207497 | Lamotrigine LAMOTRIGINE | Amneal Pharms |
| October 31, 2018 | ANDA209057 | Vardenafil VARDENAFIL HYDROCHLORIDE | Crossmedika SA |
| September 4, 2018 | ANDA209700 | Teriflunomide TERIFLUNOMIDE | Teva Pharms USA |
| September 4, 2018 | ANDA210105 | Bexarotene BEXAROTENE | Amneal Pharms Ny |
| May 7, 2018 | ANDA204717 | Carvedilol CARVEDILOL PHOSPHATE | Impax Labs Inc |
| April 17, 2018 | ANDA209701 | Clobetasol propionate CLOBETASOL PROPIONATE | Xiromed |
| March 20, 2018 | ANDA200959 | Sevelamer carbonate SEVELAMER CARBONATE | Quagen |
| February 27, 2018 | ANDA210186 | Oseltamivir phosphate OSELTAMIVIR PHOSPHATE | Amneal Pharms Ny |
| February 9, 2018 | ANDA209951 | Fenofibrate FENOFIBRATE | Amneal |
| January 26, 2018 | ANDA090636 | Tenofovir disoproxil fumarate TENOFOVIR DISOPROXIL FUMARATE | Hetero Labs Ltd III |
| January 26, 2018 | ANDA210347 | Piroxicam PIROXICAM | Strides Pharma |
| January 22, 2018 | ANDA210194 | Estradiol ESTRADIOL | Padagis Israel |
| December 19, 2017 | ANDA207803 | Fenofibrate FENOFIBRATE | Bostal |
| October 20, 2017 | ANDA205229 | Progesterone PROGESTERONE | Xiromed |
| September 7, 2017 | ANDA207724 | Progesterone PROGESTERONE | Amneal Pharms Ny |
| August 28, 2017 | ANDA204660 | Azelastine hydrochloride AZELASTINE HYDROCHLORIDE | Amneal |
| June 8, 2017 | ANDA090894 | Emtricitabine and tenofovir disoproxil fumarate EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | Teva Pharms USA |
| May 30, 2017 | ANDA079022 | Atomoxetine ATOMOXETINE HYDROCHLORIDE | Teva Pharms USA |
| May 25, 2017 | ANDA203821 | Nebivolol NEBIVOLOL HYDROCHLORIDE | Glenmark Pharms Ltd |
| May 17, 2017 | ANDA209093 | Oseltamivir phosphate OSELTAMIVIR PHOSPHATE | Amneal Pharms |
| February 3, 2017 | ANDA205932 | Pitavastatin PITAVASTATIN CALCIUM | Orient Pharma Co Ltd |
| January 27, 2017 | ANDA208328 | Memantine and donepezil MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE | Amneal |
| December 22, 2016 | ANDA206647 | Alosetron hydrochloride ALOSETRON HYDROCHLORIDE | Amneal Pharms |
| December 13, 2016 | ANDA207427 | Metformin hydrochloride METFORMIN HYDROCHLORIDE | Regcon Holdings |
| October 27, 2016 | ANDA205530 | Acetazolamide ACETAZOLAMIDE | Heritage Pharma |
| July 18, 2016 | ANDA205220 | Valganciclovir VALGANCICLOVIR HYDROCHLORIDE | Actavis Labs Fl Inc |
| July 12, 2016 | ANDA204598 | Fenofibrate FENOFIBRATE | Hetero Labs Ltd III |
| June 23, 2016 | ANDA206043 | Primaquine phosphate PRIMAQUINE PHOSPHATE | Ingenus Pharms LLC |
| May 31, 2016 | ANDA208278 | Amantadine AMANTADINE HYDROCHLORIDE | Zydus Pharms |
| March 8, 2016 | ANDA206392 | Aspirin and extended-release dipyridamole ASPIRIN AND DIPYRIDAMOLE | Amneal Pharms |
| January 11, 2016 | ANDA204011 | Valsartan VALSARTAN | Amneal Pharms |
| November 20, 2015 | ANDA203118 | Dutasteride DUTASTERIDE | Amneal Pharms |
| November 12, 2015 | ANDA206652 | Entecavir ENTECAVIR | Amneal Pharms |
| September 17, 2015 | ANDA202956 | Zolmitriptan ZOLMITRIPTAN | Jubilant Generics |
| September 8, 2015 | ANDA204415 | Telmisartan TELMISARTAN | Amneal Pharms |
| July 30, 2015 | ANDA091133 | Benzonatate BENZONATATE | Onesource Specialty |
| June 29, 2015 | ANDA202315 | Calcium acetate CALCIUM ACETATE | Heritage Pharms Inc |
| May 29, 2015 | ANDA205256 | Estradiol ESTRADIOL | Amneal Pharms |
| May 22, 2015 | ANDA204633 | Acitretin ACITRETIN | Sigmapharm Labs LLC |
| February 23, 2015 | ANDA203534 | Irbesartan IRBESARTAN | Jubilant Generics |
| November 4, 2014 | ANDA200790 | Valganciclovir VALGANCICLOVIR HYDROCHLORIDE | Strides Pharma Intl |
| September 10, 2014 | ANDA202438 | Famciclovir FAMCICLOVIR | Hetero Labs Ltd V |
| March 18, 2014 | ANDA202960 | Atovaquone ATOVAQUONE | Amneal Pharms |
| January 10, 2014 | ANDA077210 | Pioglitazone PIOGLITAZONE HYDROCHLORIDE | Teva Pharms USA |
| June 21, 2013 | ANDA203399 | Metaxalone METAXALONE | Amneal Pharms |
| April 23, 2013 | ANDA091482 | Fluvoxamine maleate FLUVOXAMINE MALEATE | Actavis Elizabeth |
| March 25, 2013 | ANDA202074 | Olanzapine and fluoxetine OLANZAPINE AND FLUOXETINE HYDROCHLORIDE | Teva Pharms |
| February 28, 2013 | ANDA202025 | Sildenafil SILDENAFIL CITRATE | Amneal Pharms |
| February 14, 2013 | ANDA202540 | Ursodiol URSODIOL | Ph Health |
| September 18, 2012 | ANDA201845 | Losartan potassium and hydrochlorothiazide LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | Jubilant Cadista |
| August 3, 2012 | ANDA200405 | Montelukast MONTELUKAST SODIUM | Lannett Co Inc |
| July 30, 2012 | ANDA200275 | Norethindrone acetate NORETHINDRONE ACETATE | Amneal Pharms |
| July 9, 2012 | ANDA201089 | Diclofenac sodium and misoprostol DICLOFENAC SODIUM AND MISOPROSTOL | Actavis Labs Fl Inc |
| June 19, 2012 | ANDA077528 | Olanzapine and fluoxetine OLANZAPINE AND FLUOXETINE HYDROCHLORIDE | Teva Pharms |
| May 17, 2012 | ANDA090869 | Ropinirole ROPINIROLE HYDROCHLORIDE | Actavis Elizabeth |
| February 3, 2012 | ANDA078868 | Tizanidine TIZANIDINE HYDROCHLORIDE | Apotex Inc |
| July 15, 2011 | ANDA078703 | Propranolol hydrochloride PROPRANOLOL HYDROCHLORIDE | Adare Pharms Inc |
| June 3, 2011 | ANDA090289 | Letrozole LETROZOLE | Teva Pharms |
| February 14, 2011 | ANDA091616 | Lithium carbonate LITHIUM CARBONATE | Glenmark Pharms Ltd |
| June 28, 2010 | ANDA076565 | Venlafaxine hydrochloride VENLAFAXINE HYDROCHLORIDE | Teva |
| June 28, 2010 | ANDA078058 | Anastrozole ANASTROZOLE | Teva Pharms |
| June 28, 2010 | ANDA079220 | Anastrozole ANASTROZOLE | Natco Pharma Ltd |
| June 10, 2010 | ANDA090055 | Mycophenolate mofetil MYCOPHENOLATE MOFETIL | Strides Pharma |
| June 10, 2010 | ANDA090456 | Mycophenolate mofetil MYCOPHENOLATE MOFETIL | Strides Pharma |
| March 2, 2010 | ANDA090377 | Tamsulosin hydrochloride TAMSULOSIN HYDROCHLORIDE | Impax Labs |
| November 16, 2009 | ANDA040885 | Butalbital, acetaminophen and caffeine BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | Lgm Pharma |
| February 4, 2009 | ANDA078503 | Oxybutynin OXYBUTYNIN CHLORIDE | Osmotica Pharm Us |
| January 27, 2009 | ANDA079132 | Lamotrigine LAMOTRIGINE | Jubilant Cadista |
| December 29, 2008 | ANDA078707 | Risperidone RISPERIDONE | Renata |
| June 2, 2008 | ANDA077419 | Potassium chloride POTASSIUM CHLORIDE | Actavis Labs Fl Inc |
| May 29, 2008 | ANDA078720 | Amantadine AMANTADINE HYDROCHLORIDE | Bionpharma |
| April 23, 2008 | ANDA040866 | Primidone PRIMIDONE | Amneal Pharm |
| August 24, 2007 | ANDA077487 | Famciclovir FAMCICLOVIR | Teva Pharms |
| August 22, 2007 | ANDA077666 | Mirtazapine MIRTAZAPINE | Apotex |
| June 28, 2007 | ANDA076846 | Amlodipine AMLODIPINE BESYLATE | Teva |
| June 27, 2007 | ANDA078152 | Ondansetron ONDANSETRON | Glenmark Pharms Ltd |
| May 9, 2007 | ANDA065368 | Cefdinir CEFDINIR | Teva Pharms |
| September 12, 2006 | ANDA077746 | Midodrine hydrochloride MIDODRINE HYDROCHLORIDE | Apotex |
| April 19, 2006 | ANDA077563 | Cyclobenzaprine hydrochloride CYCLOBENZAPRINE HYDROCHLORIDE | Jubilant Cadista |
| January 5, 2006 | ANDA077317 | Isradipine ISRADIPINE | Watson Labs Teva |
| November 14, 2005 | ANDA065218 | Azithromycin AZITHROMYCIN | Pliva |
| October 28, 2005 | ANDA077270 | Glipizide and metformin hydrochloride GLIPIZIDE AND METFORMIN HYDROCHLORIDE | Teva Pharms |
| September 13, 2005 | ANDA077090 | Leflunomide LEFLUNOMIDE | Apotex |
| February 18, 2005 | ANDA040547 | Methimazole METHIMAZOLE | Aiping Pharm Inc |
| January 27, 2005 | ANDA076899 | Sulfamethoxazole and trimethoprim SULFAMETHOXAZOLE AND TRIMETHOPRIM | Amneal Pharms Ny |
| December 20, 2004 | ANDA075317 | Terazosin hydrochloride TERAZOSIN HYDROCHLORIDE | Jubilant Cadista |
| December 10, 2004 | ANDA077030 | Cilostazol CILOSTAZOL | Apotex |
| April 22, 2004 | ANDA076541 | Mirtazapine MIRTAZAPINE | Sun Pharm Inds Inc |
| March 26, 2004 | ANDA076796 | Furosemide FUROSEMIDE | Prinston Inc |
| August 29, 2003 | ANDA040516 | Chloroquine phosphate CHLOROQUINE PHOSPHATE | Impax Labs |
| June 5, 2003 | NDA021532 | Olmesartan medoxomil and hydrochlorothiazide BENICAR HCT | Cosette |
| May 30, 2003 | ANDA076346 | Torsemide TORSEMIDE | Pliva Pharm Ind |
| March 18, 2002 | ANDA040431 | Fludrocortisone acetate FLUDROCORTISONE ACETATE | Impax Labs |
| October 18, 2000 | ANDA075580 | Doxazosin DOXAZOSIN MESYLATE | Apotex |
| December 30, 1999 | ANDA075047 | Acebutolol hydrochloride ACEBUTOLOL HYDROCHLORIDE | Amneal Pharm |
| May 26, 1999 | ANDA075274 | Naltrexone hydrochloride NALTREXONE HYDROCHLORIDE | Elite Labs |
| November 20, 1998 | ANDA074726 | Potassium chloride KLOR-CON M10, KLOR-CON M15, KLOR-CON M20 | Upsher Smith Labs |
| November 13, 1998 | ANDA075185 | Diclofenac DICLOFENAC SODIUM | Carlsbad |
| October 28, 1998 | ANDA074737 | Captopril CAPTOPRIL | Macleods Pharms |
| October 16, 1998 | ANDA075143 | Hydroxyurea HYDROXYUREA | Barr |
| September 26, 1996 | NDA020547 | Zafirlukast ACCOLATE | Strides Pharma Intl |
| February 16, 1996 | ANDA074069 | Azathioprine AZATHIOPRINE | Amneal |
| May 16, 1995 | ANDA074377 | Mexiletine hydrochloride MEXILETINE HYDROCHLORIDE | Teva |
| September 3, 1993 | ANDA074260 | Carbidopa and levodopa CARBIDOPA AND LEVODOPA | Actavis Elizabeth |
| October 15, 1990 | ANDA081099 | Methotrexate METHOTREXATE SODIUM | Barr |
| April 30, 1990 | ANDA089763 | Theophylline THEOPHYLLINE | Heritage Pharma Avet |
| July 15, 1988 | ANDA062713 | Cephalexin CEPHALEXIN | Ajenat Pharms |
| April 5, 1988 | ANDA071881 | Verapamil hydrochloride VERAPAMIL HYDROCHLORIDE | Heritage |
| March 9, 1988 | ANDA071525 | Trazodone hydrochloride TRAZODONE HYDROCHLORIDE | Pliva |
| December 31, 1987 | NDA019594 | Ursodiol ACTIGALL | Teva Branded Pharm |
| December 11, 1987 | ANDA071523 | Trazodone hydrochloride TRAZODONE HYDROCHLORIDE | Teva Pharms USA |
| December 11, 1987 | ANDA071524 | Trazodone hydrochloride TRAZODONE HYDROCHLORIDE | Teva Pharms USA |
| February 13, 1987 | ANDA062702 | Cephalexin CEPHALEXIN | Teva |
| April 17, 1986 | NDA019123 | Potassium chloride KLOR-CON | Upsher Smith Labs |
| July 29, 1985 | ANDA070184 | Metoclopramide METOCLOPRAMIDE HYDROCHLORIDE | Teva |
| January 16, 1984 | ANDA062506 | Nystatin NYSTATIN | Teva |
| July 3, 1979 | ANDA086841 | Dapsone DAPSONE | Everest Life Sci |
| October 16, 1978 | ANDA080704 | Ergocalciferol VITAMIN D | Bionpharma |
| — | ANDA072708 | Minoxidil | — |
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
2025
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November 18, 2025 · Class III · Ongoing · D-0222-2026 · Nebivolol
Cross Contamination with Other Products
Nebivolol Tablets, 20 mg, 90 Tablets, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for Avkare, Pulaski, TN 38478, Product of Italy, NDC 42291-874-90.
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June 26, 2025 · Class III · Ongoing · D-0529-2025 · Pitavastatin
Failed Impurity/Degradation Specifications
Pitavastatin Tablets, 2 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 42291-906-90
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June 26, 2025 · Class III · Ongoing · D-0528-2025 · Pitavastatin
Failed Impurity/Degradation Specifications
Pitavastatin Tablets, 1 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 42291-905-90
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February 4, 2025 · Class II · Ongoing · D-0229-2025 · Silodosin
Subpotent Drug: Out of Specification (OOS) result for De hydro Impurity (0.654%) for 18 M Stability sample and low assay 94.9% (specification of NLT 95.0% NMT 105%)
Silodosin Capsules, 8mg, 90-count bottle, Rx only, Manufactured for: AvKare, Pulaski, TN 38478, Manufactured by: Amneal Pharmaceuticals of NY, LLC, NY 11719, NDC 42291-778-90
2024
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October 18, 2024 · Class II · Ongoing · D-0104-2025 · Sunitinib malate
Labeling: Label Mix-Up
Sunitinib Malate Capsules, 25 mg, 28-count bottles, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 42291-902-28
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October 18, 2024 · Class II · Ongoing · D-0103-2025 · Sunitinib malate
Labeling: Label Mix-Up
Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 42291-901-28
2022
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July 20, 2022 · Class III · Terminated · D-1329-2022 · Lamotrigine
Labeling: Label Error on Declared Strength
Lamotrigine Tablets, USP 100 mg, 1000-count bottles, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-367-10, UPC 3 42291 36710 4
2020
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May 28, 2020 · Class III · Terminated · D-1289-2020 · Lamotrigine
Presence of Foreign Substance consistent with granules from desiccant packs used during storage
Lamotrigine Tablets, USP, 150 mg, Rx Only, a) 60 count Bottle, NDC 42291-368-60, b) 500 count Bottle, NDC 42291-368-50, Manufactured for: AvKARE, Inc. Pulaski, TN 38478.
2019
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March 1, 2019 · Class III · Terminated · D-0990-2019 · Oxybutynin
Failed Dissolution Specifications
Oxybutynin Chloride Extended-Release Tablets USP 10 mg, a) 100 tablets (NDC 42291-634-01) and b) 500 tablets (NDC 42291-634-50) bottles, Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478
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).
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026