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Drug company (FDA labeler)

Golden State Medical Supply, Inc.

NDC labeler codes: 51407, 60429, 84677

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.

At a glance

232Prescription medicines
645Products (NDC)
285FDA applications
9Recalls

Prescription medicines

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.
ApprovedApplicationMedicineSponsor
June 25, 2026ANDA220972 Tofacitinib
TOFACITINIB CITRATE		Sciegen Pharms
June 3, 2026ANDA204196 Dextromethorphan hydrobromide and quinidine sulfate
DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE		Sun Pharm
June 3, 2026ANDA218096 Tofacitinib
TOFACITINIB CITRATE		Apotex
April 30, 2026ANDA202426 Sitagliptin and metformin hydrochloride
SITAGLIPTIN AND METFORMIN HYDROCHLORIDE		Apotex
April 23, 2026ANDA204687 Valsartan and hydrochlorothiazide
VALSARTAN AND HYDROCHLOROTHIAZIDE		Sciegen Pharms
April 6, 2026ANDA211491 Dapagliflozin and metformin hydrochloride
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE		Sun Pharm
April 2, 2026ANDA219819 Nintedanib
NINTEDANIB ESYLATE		Dexcel
March 31, 2026ANDA208465 Olmesartan medoxomil and hydrochlorothiazide
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE		Sciegen Pharms
January 20, 2026ANDA202425 Sitagliptin
SITAGLIPTIN PHOSPHATE		Apotex
October 7, 2025ANDA219677 Lamotrigine
LAMOTRIGINE		Taro
August 6, 2025ANDA219058 Doxepin hydrochloride
DOXEPIN HYDROCHLORIDE		Taro
May 1, 2025ANDA208584 Ticagrelor
TICAGRELOR		Apotex
March 6, 2025ANDA202954 Sildenafil
SILDENAFIL CITRATE		Jubilant Generics
October 16, 2024ANDA219251 Fludrocortisone acetate
FLUDROCORTISONE ACETATE		Zydus Lifesciences
August 8, 2024ANDA218988 Trazodone hydrochloride
TRAZODONE HYDROCHLORIDE		Granules
May 28, 2024ANDA213682 Sacubitril and valsartan
SACUBITRIL AND VALSARTAN		Alembic
December 7, 2023ANDA211236 Eslicarbazepine acetate
ESLICARBAZEPINE ACETATE		Apotex
October 19, 2023ANDA217713 Pazopanib
PAZOPANIB HYDROCHLORIDE		Apotex
August 31, 2023ANDA217753 Alvimopan
ALVIMOPAN		Hikma
August 7, 2023ANDA217269 Guanfacine
GUANFACINE HYDROCHLORIDE		Alembic
June 6, 2023ANDA217533 Mesalamine
MESALAMINE		Amta
June 1, 2023ANDA216782 Dicyclomine hydrochloride
DICYCLOMINE HYDROCHLORIDE		Twi Pharms
May 31, 2023ANDA212709 Pirfenidone
PIRFENIDONE		Apotex
April 18, 2023ANDA212490 Roflumilast
ROFLUMILAST		Alkem Labs Ltd
April 3, 2023ANDA214823 Doxepin hydrochloride
DOXEPIN HYDROCHLORIDE		Msn
March 15, 2023ANDA215787 Diclofenac
DICLOFENAC POTASSIUM		Pharmazone
January 20, 2023NDA214373 Bexagliflozin
BRENZAVVY		Theracosbio
December 22, 2022ANDA210385 Dimethyl fumarate
DIMETHYL FUMARATE		Aurobindo Pharma
November 25, 2022ANDA216209 Ramelteon
RAMELTEON		Xiromed
November 9, 2022ANDA209050 Sorafenib
SORAFENIB TOSYLATE		Yabao Pharm
October 28, 2022ANDA216393 Trimethoprim
TRIMETHOPRIM		Novitium Pharma
September 16, 2022ANDA202666 Dexlansoprazole
DEXLANSOPRAZOLE		Twi Pharms
May 19, 2022ANDA210701 Ambrisentan
AMBRISENTAN		Apotex
May 18, 2022ANDA210568 Cefpodoxime proxetil
CEFPODOXIME PROXETIL		Alkem Labs Ltd
May 10, 2022ANDA212226 Posaconazole
POSACONAZOLE		Specgx LLC
March 23, 2022ANDA215788 Ketorolac tromethamine
KETOROLAC TROMETHAMINE		Pharmazone
March 17, 2022ANDA204921 Lacosamide
LACOSAMIDE		Msn Labs Pvt Ltd
January 25, 2022ANDA215885 Baclofen
BACLOFEN		Mankind Pharma
December 30, 2021ANDA214051 Ivabradine
IVABRADINE HYDROCHLORIDE		Ingenus Pharms LLC
November 26, 2021ANDA214403 Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE		Lannett Co Inc
November 18, 2021ANDA201942 Rasagiline
RASAGILINE MESYLATE		Carnegie
November 10, 2021ANDA208195 Entecavir
ENTECAVIR		Yung Shin Pharm
October 29, 2021ANDA215563 Bisoprolol fumarate
BISOPROLOL FUMARATE		Novitium Pharma
October 6, 2021ANDA215001 Loperamide hydrochloride
LOPERAMIDE HYDROCHLORIDE		Edenbridge Pharms
July 26, 2021ANDA211975 Erythromycin
ERYTHROMYCIN		Torrent
June 30, 2021ANDA209437 Icosapent ethyl
ICOSAPENT ETHYL		Apotex
April 20, 2021ANDA215043 Famotidine
FAMOTIDINE		Novitium Pharma
March 30, 2021ANDA212918 Atovaquone
ATOVAQUONE		Bionpharma
March 30, 2021ANDA213827 Metolazone
METOLAZONE		Innogenix
February 18, 2021ANDA214017 Droxidopa
DROXIDOPA		Sciegen Pharms
February 10, 2021ANDA208476 Fenofibrate
FENOFIBRATE		Bostal
January 22, 2021ANDA210344 Ursodiol
URSODIOL		Strides Pharma
January 22, 2021ANDA212996 Chlorpromazine hydrochloride
CHLORPROMAZINE HYDROCHLORIDE		Lannett Co Inc
January 13, 2021ANDA091055 Emtricitabine and tenofovir disoproxil fumarate
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE		Strides Pharma
January 7, 2021ANDA214534 Fluphenazine hydrochloride
FLUPHENAZINE HYDROCHLORIDE		DR Reddys
December 10, 2020ANDA212977 Omeprazole
OMEPRAZOLE		Xiromed
November 27, 2020ANDA210068 Methenamine hippurate
METHENAMINE HIPPURATE		Ingenus Pharms LLC
October 21, 2020ANDA211835 Aprepitant
APREPITANT		Torrent
October 14, 2020ANDA210382 Dimethyl fumarate
DIMETHYL FUMARATE		Twi Pharms
October 1, 2020ANDA207849 Midodrine hydrochloride
MIDODRINE HYDROCHLORIDE		Xiromed
July 15, 2020ANDA209946 Colesevelam hydrochloride
COLESEVELAM HYDROCHLORIDE		Zhejiang Jingxin
July 6, 2020ANDA212015 Erythromycin
ERYTHROMYCIN		Torrent
April 8, 2020ANDA213438 Hydroxyurea
HYDROXYUREA		Leading
April 6, 2020ANDA205232 Perphenazine
PERPHENAZINE		Zydus Pharms
March 17, 2020ANDA206093 Tetrabenazine
TETRABENAZINE		Apotex
February 5, 2020ANDA210425 Colchicine
COLCHICINE		Granules
December 16, 2019ANDA212670 Zileuton
ZILEUTON		Strides Pharma Intl
October 15, 2019ANDA205414 Febuxostat
FEBUXOSTAT		Hikma
October 2, 2019ANDA211494 Clobetasol propionate
CLOBETASOL PROPIONATE		Saptalis Pharms
September 30, 2019ANDA208212 Vilazodone hydrochloride
VILAZODONE HYDROCHLORIDE		Teva Pharms USA
September 4, 2019ANDA208058 Lurasidone hydrochloride
LURASIDONE HYDROCHLORIDE		Heritage Pharma Avet
August 19, 2019ANDA204562 Tolterodine tartrate
TOLTERODINE TARTRATE		Inventia Hlthcare
August 13, 2019ANDA204975 Fesoterodine fumarate
FESOTERODINE FUMARATE		DR Reddys
July 19, 2019ANDA208677 Pregabalin
PREGABALIN		Sciegen Pharms
June 14, 2019ANDA208783 Diltiazem
DILTIAZEM HYDROCHLORIDE		Novast Labs
May 20, 2019ANDA211657 Solifenacin succinate
SOLIFENACIN SUCCINATE		Sciegen Pharms
May 14, 2019ANDA211117 Albendazole
ALBENDAZOLE		Edenbridge Pharms
April 29, 2019ANDA204800 Felodipine
FELODIPINE		Yung Shin Pharm
April 24, 2019ANDA206381 Rosuvastatin
ROSUVASTATIN CALCIUM		Sciegen Pharms
April 5, 2019ANDA211642 Thiothixene
THIOTHIXENE		Novitium Pharma
November 23, 2018ANDA211542 Temazepam
TEMAZEPAM		Alembic
November 21, 2018ANDA210992 Methylphenidate
METHYLPHENIDATE HYDROCHLORIDE		Granules
November 14, 2018ANDA205869 Letrozole
LETROZOLE		Pharmobedient
November 5, 2018ANDA210918 Isosorbide mononitrate
ISOSORBIDE MONONITRATE		Riconpharma LLC
October 31, 2018ANDA208446 Abiraterone acetate
ABIRATERONE ACETATE		Mylan
October 22, 2018ANDA209687 Clobazam
CLOBAZAM		Upsher Smith Labs
August 30, 2018ANDA205231 Diltiazem
DILTIAZEM HYDROCHLORIDE		Twi Pharms
July 30, 2018ANDA206765 Dalfampridine
DALFAMPRIDINE		Alkem Labs Ltd
July 23, 2018ANDA210955 Nadolol
NADOLOL		Regcon Holdings
June 29, 2018ANDA208130 Olmesartan medoxomil
OLMESARTAN MEDOXOMIL		Sciegen Pharms
June 20, 2018ANDA209603 Labetalol
LABETALOL HYDROCHLORIDE		Appco
May 22, 2018NDA210308 Abiraterone acetate
YONSA		Sun Pharm
April 30, 2018ANDA209735 Esomeprazole
ESOMEPRAZOLE MAGNESIUM		Sun Pharm
April 13, 2018ANDA209869 Pravastatin sodium
PRAVASTATIN SODIUM		Biocon Pharma
February 13, 2018ANDA205210 Doxazosin
DOXAZOSIN MESYLATE		Heritage Pharma
February 6, 2018ANDA204106 Metoprolol
METOPROLOL SUCCINATE		Novast Labs
December 26, 2017ANDA203832 Metformin hydrochloride
METFORMIN HYDROCHLORIDE		Mpp Pharma
November 29, 2017ANDA209635 Quetiapine
QUETIAPINE FUMARATE		Sciegen Pharms
October 25, 2017ANDA090132 Carvedilol
CARVEDILOL PHOSPHATE		Sun Pharm Industries
October 23, 2017ANDA209823 Oxybutynin
OXYBUTYNIN CHLORIDE		Novitium Pharma
September 29, 2017ANDA206094 Sevelamer carbonate
SEVELAMER CARBONATE		DR Reddys
September 14, 2017ANDA209966 Modafinil
MODAFINIL		Cadila
August 16, 2017ANDA206261 Acyclovir
ACYCLOVIR		Carlsbad
August 11, 2017ANDA207405 Tamsulosin hydrochloride
TAMSULOSIN HYDROCHLORIDE		Alkem Labs Ltd
July 28, 2017ANDA205327 Methylphenidate
METHYLPHENIDATE HYDROCHLORIDE		Osmotica Pharm Us
July 12, 2017ANDA205927 Prasugrel
PRASUGREL		Mylan
July 3, 2017ANDA203481 Omeprazole
OMEPRAZOLE		Breckenridge
June 30, 2017ANDA090080 Moxifloxacin
MOXIFLOXACIN HYDROCHLORIDE		Apotex
June 21, 2017ANDA204644 Imatinib mesylate
IMATINIB MESYLATE		Mylan
June 16, 2017ANDA203899 Niacin
NIACIN		Quagen
June 12, 2017ANDA207311 Ezetimibe
EZETIMIBE		Ohm Labs Inc
June 5, 2017ANDA091640 Mesalamine
MESALAMINE		Zydus Pharms
May 30, 2017ANDA078983 Atomoxetine
ATOMOXETINE HYDROCHLORIDE		Apotex
April 26, 2017ANDA200909 Ezetimibe and simvastatin
EZETIMIBE AND SIMVASTATIN		DR Reddys Labs SA
February 3, 2017ANDA205955 Pitavastatin
PITAVASTATIN CALCIUM		Sawai USA
August 26, 2016ANDA208191 Nitroglycerin
NITROGLYCERIN		DR Reddys
August 25, 2016ANDA202987 Nifedipine
NIFEDIPINE		Novast Labs
July 25, 2016ANDA203203 Lansoprazole
LANSOPRAZOLE		Xiromed
March 22, 2016ANDA091161 Mometasone furoate (mometasone)
MOMETASONE FUROATE		Apotex
September 23, 2015ANDA205087 Cyproheptadine
CYPROHEPTADINE HYDROCHLORIDE		Ingenus Pharms LLC
July 10, 2015ANDA203431 Travoprost ophthalmic solution
TRAVOPROST		Apotex
June 22, 2015ANDA205650 Pyridostigmine bromide
PYRIDOSTIGMINE BROMIDE		Zydus Pharms
June 2, 2015ANDA201408 Guanfacine
GUANFACINE HYDROCHLORIDE		Twi Pharms
June 1, 2015ANDA201087 Amlodipine besylate valsartan hydrochlorothiazide
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE		Strides Pharma Intl
April 16, 2015ANDA203659 Nebivolol
NEBIVOLOL HYDROCHLORIDE		Ani Pharms
October 29, 2014ANDA203104 Donepezil hydrochloride
DONEPEZIL HYDROCHLORIDE		Twi Pharms
October 29, 2014ANDA203907 Donepezil hydrochloride
DONEPEZIL HYDROCHLORIDE		Sciegen Pharms
October 28, 2014ANDA203855 Pramipexole dihydrochloride
PRAMIPEXOLE DIHYDROCHLORIDE		Sciegen Pharms
September 9, 2014ANDA203646 Levocetirizine dihydrochloride
LEVOCETIRIZINE DIHYDROCHLORIDE		Sciegen Pharms
August 25, 2014ANDA202330 Buspirone
BUSPIRONE HYDROCHLORIDE		Strides Pharma
August 20, 2014ANDA204279 Hydroxyzine
HYDROXYZINE HYDROCHLORIDE		Heritage
August 6, 2014ANDA203546 Potassium citrate
POTASSIUM CITRATE		Zydus Pharms
June 27, 2014ANDA203326 Buprenorphine and naloxone
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE		Hikma
June 11, 2014ANDA203088 Duloxetine
DULOXETINE HYDROCHLORIDE		Breckenridge
May 27, 2014ANDA202362 Atovaquone and proguanil hydrochloride
ATOVAQUONE AND PROGUANIL HYDROCHLORIDE		Mylan
April 7, 2014ANDA091028 OMEGA-3-ACID ethyl esters
OMEGA-3-ACID ETHYL ESTERS		Pharmobedient
April 3, 2014ANDA203126 Nifedipine
NIFEDIPINE		Twi Pharms
February 3, 2014ANDA077667 Modafinil
MODAFINIL		Apotex
February 3, 2014ANDA091182 Glycopyrrolate
GLYCOPYRROLATE		Regcon Holdings
January 2, 2014ANDA202941 Lamivudine
LAMIVUDINE		Apotex
December 30, 2013ANDA091431 Amlodipine besylate and benazepril hydrochloride
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE		Heritage
December 11, 2013ANDA090694 Duloxetine
DULOXETINE HYDROCHLORIDE		Lupin
November 8, 2013ANDA090678 Rabeprazole sodium
RABEPRAZOLE SODIUM		Lannett Co Inc
September 16, 2013ANDA091649 Capecitabine
CAPECITABINE		Teva Pharms USA
September 11, 2013ANDA203769 Metformin hydrochloride
METFORMIN HYDROCHLORIDE		Sciegen Pharms
August 16, 2013ANDA200900 Progesterone
PROGESTERONE		Bionpharma
August 8, 2013ANDA091681 Disulfiram
DISULFIRAM		Alvogen
July 1, 2013ANDA203062 Rizatriptan benzoate
RIZATRIPTAN BENZOATE		Aurobindo Pharma Ltd
June 3, 2013ANDA201507 Hydroxyzine
HYDROXYZINE PAMOATE		Heritage Pharma
May 24, 2013ANDA091174 Calcitriol
CALCITRIOL		Bionpharma
March 28, 2013ANDA090011 Amlodipine and valsartan
AMLODIPINE BESYLATE AND VALSARTAN		Strides Pharma Intl
March 26, 2013ANDA091151 Eszopiclone
ESZOPICLONE		Mylan Pharms Inc
December 31, 2012ANDA202490 Rizatriptan benzoate
RIZATRIPTAN BENZOATE		Aurobindo Pharma Ltd
October 12, 2012ANDA091289 Trospium chloride
TROSPIUM CHLORIDE		Actavis Labs Fl Inc
October 1, 2012ANDA202496 Ipratropium bromide and albuterol sulfate
ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE		Ritedose Corp
August 21, 2012ANDA091558 Mycophenolic acid
MYCOPHENOLATE SODIUM		Apotex Inc
April 23, 2012ANDA090798 Olanzapine
OLANZAPINE		Apotex Inc
March 27, 2012ANDA090120 Quetiapine
QUETIAPINE FUMARATE		Hikma
March 27, 2012ANDA090749 Quetiapine
QUETIAPINE FUMARATE		Hikma
March 19, 2012ANDA078948 Ibandronate sodium
IBANDRONATE SODIUM		Apotex Inc
March 2, 2012ANDA077561 Ziprasidone
ZIPRASIDONE HYDROCHLORIDE		Apotex
December 2, 2011ANDA091606 Lamivudine
LAMIVUDINE		Apotex
October 24, 2011ANDA091265 Olanzapine
OLANZAPINE		Apotex Inc
September 12, 2011ANDA091261 Levetiracetam
LEVETIRACETAM		Apotex Inc
July 15, 2011ANDA078703 Propranolol hydrochloride
PROPRANOLOL HYDROCHLORIDE		Adare Pharms Inc
June 20, 2011ANDA076710 Levofloxacin
LEVOFLOXACIN		DR Reddys Labs Inc
May 25, 2011ANDA090935 Warfarin sodium
WARFARIN SODIUM		Invagen Pharms
March 7, 2011ANDA078423 Fluconazole
FLUCONAZOLE		Ani Pharms
January 20, 2011ANDA078281 Pantoprazole sodium
PANTOPRAZOLE SODIUM		Lannett Co Inc
September 17, 2010ANDA090596 Tacrolimus
TACROLIMUS		Mylan
August 3, 2010ANDA090455 Ergocalciferol
ERGOCALCIFEROL		Onesource
June 10, 2010ANDA090314 Sumatriptan
SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE (AUTOINJECTOR)		Onesource Specialty
June 7, 2010ANDA065496 Cefuroxime axetil
CEFUROXIME AXETIL		Alkem Labs Ltd
June 4, 2010ANDA077714 Terbinafine hydrochloride
TERBINAFINE HYDROCHLORIDE		Breckenridge Pharm
September 22, 2009ANDA077911 Glimepiride
GLIMEPIRIDE		Carlsbad
September 9, 2009ANDA077463 Nateglinide
NATEGLINIDE		Strides Pharma Intl
August 10, 2009ANDA077744 Sumatriptan
SUMATRIPTAN SUCCINATE		Mylan
March 31, 2009ANDA078115 Carbamazepine
CARBAMAZEPINE		Taro
March 23, 2009ANDA078828 Risperidone
RISPERIDONE		Jubilant Cadista
March 20, 2009ANDA090097 Liothyronine sodium
LIOTHYRONINE SODIUM		DR Reddys Labs SA
February 6, 2009ANDA077604 Galantamine
GALANTAMINE HYDROBROMIDE		Yabao Pharm
December 1, 2008ANDA040864 Butalbital, acetaminophen and caffeine
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE		Granules
June 13, 2008ANDA078627 Venlafaxine hydrochloride
VENLAFAXINE HYDROCHLORIDE		Sun Pharm Inds Inc
January 11, 2008ANDA078069 Oxcarbazepine
OXCARBAZEPINE		Breckenridge Pharm
December 28, 2007ANDA077806 Balsalazide disodium
BALSALAZIDE DISODIUM		Hikma
December 14, 2007ANDA040734 Methimazole
METHIMAZOLE		Heritage Pharma
October 30, 2007ANDA077002 Digoxin
DIGOXIN		Hikma
September 26, 2007NDA022100 Amlodipine and olmesartan medoxomil
AZOR		Cosette
September 12, 2007ANDA077538 Fluticasone propionate
FLUTICASONE PROPIONATE		Apotex
September 5, 2007ANDA078384 Carvedilol
CARVEDILOL		Regcon Holdings
July 2, 2007ANDA076390 Terbinafine hydrochloride
TERBINAFINE HYDROCHLORIDE		Pharmazone
June 25, 2007ANDA077851 Ondansetron
ONDANSETRON HYDROCHLORIDE		Natco Pharma Ltd
June 15, 2007NDA021875 Armodafinil
NUVIGIL		Nuvo Pharms
April 23, 2007ANDA077214 Zolpidem tartrate
ZOLPIDEM TARTRATE		Pharmazone
March 16, 2007ANDA040702 Hydrochlorothiazide
HYDROCHLOROTHIAZIDE		Leading
February 28, 2007ANDA077797 Cyclobenzaprine hydrochloride
CYCLOBENZAPRINE HYDROCHLORIDE		Prinston Inc
January 31, 2007ANDA076588 Valacyclovir
VALACYCLOVIR HYDROCHLORIDE		Sun Pharm Inds Ltd
December 20, 2006ANDA078034 Simvastatin
SIMVASTATIN		Biocon Pharma
December 7, 2006ANDA077918 Meloxicam
MELOXICAM		Yung Shin Pharm
September 5, 2006ANDA040684 Phenytoin
EXTENDED PHENYTOIN SODIUM		Taro
April 21, 2006ANDA040560 Theophylline
THEOPHYLLINE		Mpp Pharma
February 22, 2006ANDA076504 Fluticasone propionate
FLUTICASONE PROPIONATE		Hikma
January 31, 2006NDA021908 Lubiprostone
AMITIZA		Sucampo Pharma LLC
January 17, 2006ANDA076143 Bupropion
BUPROPION HYDROCHLORIDE		Apotex
September 2, 2005NDA021774 Zolpidem tartrate
AMBIEN CR		Cosette
May 31, 2005ANDA076894 Torsemide
TORSEMIDE		Heritage
May 13, 2005ANDA076433 Fenofibrate
FENOFIBRATE		Rhodes Pharms
April 29, 2005ANDA077045 Citalopram
CITALOPRAM HYDROBROMIDE		Epic Pharma
March 1, 2005ANDA076943 Torsemide
TORSEMIDE		Hikma
June 9, 2004ANDA076126 Ciprofloxacin
CIPROFLOXACIN, CIPROFLOXACIN HYDROCHLORIDE		Carlsbad
June 9, 2004ANDA076558 Ciprofloxacin
CIPROFLOXACIN, CIPROFLOXACIN HYDROCHLORIDE		Hikma
April 23, 2004ANDA076550 Propafenone hydrochloride
PROPAFENONE HYDROCHLORIDE		Ani Pharms
March 18, 2004ANDA076561 Diclofenac
CATAFLAM		Pangea
February 13, 2004ANDA040528 Mercaptopurine
MERCAPTOPURINE		Hikma
February 11, 2004ANDA076118 Benazepril hydrochloride
BENAZEPRIL HYDROCHLORIDE		Prinston Inc
January 16, 2004ANDA076704 Metoprolol
METOPROLOL TARTRATE		Mylan
July 30, 2003ANDA075356 Paroxetine
PAROXETINE HYDROCHLORIDE		Apotex
June 19, 2003ANDA076122 Mirtazapine
MIRTAZAPINE		Mylan
March 13, 2003ANDA076174 Etodolac
ETODOLAC		Taro
December 18, 2002ANDA075638 Ketoconazole
KETOZOLE		Sun Pharma Canada
October 28, 2002ANDA075882 Flecainide acetate
FLECAINIDE ACETATE		Ani Pharms
September 26, 2002ANDA076140 Sotalol hydrochloride
SOTALOL HYDROCHLORIDE		Apotex
June 19, 2002ANDA075977 Tramadol hydrochloride
TRAMADOL HYDROCHLORIDE		Teva
March 22, 2002ANDA076264 Naltrexone hydrochloride
NALTREXONE HYDROCHLORIDE		Specgx LLC
February 27, 2002ANDA075948 Carbamazepine
CARBAMAZEPINE		Apotex
December 17, 2001ANDA075551 Lovastatin
LOVASTATIN		Teva
November 14, 2001ANDA075682 Ibuprofen
IBUPROFEN		DR Reddys
October 2, 2001NDA021324 Budesonide
ENTOCORT EC		Padagis Us
July 25, 2001ANDA075671 Megestrol acetate
MEGESTROL ACETATE		Strides Pharma Intl
May 25, 2001ANDA075951 Norethindrone acetate
NORETHINDRONE ACETATE		Barr
April 16, 2001ANDA075805 Famotidine
FAMOTIDINE		Carlsbad
February 2, 2001ANDA065061 Clindamycin
CLINDAMYCIN HYDROCHLORIDE		Sun Pharm Inds Ltd
January 23, 2001ANDA075657 Enalapril maleate
ENALAPRIL MALEATE		Taro
December 1, 2000ANDA065055 Doxycycline
DOXYCYCLINE		Strides Pharma Intl
October 24, 2000ANDA075687 Carbamazepine
CARBAMAZEPINE		Taro Pharm Inds
October 20, 2000ANDA040409 Hydrocodone bitartrate and acetaminophen
ANEXSIA 5/325		Specgx LLC
July 15, 1999ANDA040301 Warfarin sodium
WARFARIN SODIUM		Taro
June 15, 1999ANDA075319 Ketoconazole
KETOCONAZOLE		Taro
June 7, 1999ANDA075252 Azathioprine
AZASAN		Aaipharma LLC
April 30, 1999ANDA075382 Acyclovir
ACYCLOVIR		Carlsbad
March 19, 1999NDA020612 Lidocaine
LIDODERM		Teikoku Pharma USA
December 24, 1998ANDA040254 Trihexyphenidyl hydrochloride
TRIHEXYPHENIDYL HYDROCHLORIDE		Novitium Pharma
December 24, 1998NDA020717 Modafinil
PROVIGIL		Nuvo Pharms
November 13, 1998ANDA075185 Diclofenac
DICLOFENAC SODIUM		Carlsbad
June 4, 1998NDA020838 Candesartan cilexetil
ATACAND		Ani Pharms
April 30, 1998ANDA075078 Etodolac
ETODOLAC		Taro
March 11, 1998ANDA075074 Etodolac
ETODOLAC		Taro Pharm Inds
June 6, 1997ANDA074871 Selegiline
SELEGILINE HYDROCHLORIDE		Apotex
February 28, 1997ANDA040204 Dicyclomine hydrochloride
DICYCLOMINE HYDROCHLORIDE		Hikma
December 31, 1996ANDA074694 Clomipramine hydrochloride
CLOMIPRAMINE HYDROCHLORIDE		Taro
October 3, 1996ANDA074649 Carbamazepine
CARBAMAZEPINE		Taro
May 16, 1996ANDA074450 Mexiletine hydrochloride
MEXILETINE HYDROCHLORIDE		Ani Pharms
March 26, 1996ANDA074514 Diclofenac
DICLOFENAC SODIUM		Actavis Elizabeth
February 13, 1996ANDA074505 Captopril
CAPTOPRIL		Hikma
October 18, 1995ANDA074007 Acebutolol hydrochloride
ACEBUTOLOL HYDROCHLORIDE		Ani Pharms
October 4, 1995NDA020498 Bicalutamide
CASODEX		Ani Pharms
August 31, 1995ANDA074497 Glipizide
GLIPIZIDE		Ani Pharms
July 27, 1995ANDA074299 Indapamide
INDAPAMIDE		Ani Pharms
June 30, 1993ANDA040001 Methazolamide
METHAZOLAMIDE		Ani Pharms
January 29, 1993ANDA081297 Benzonatate
BENZONATATE		Bionpharma
May 15, 1992ANDA081235 Methotrexate
METHOTREXATE SODIUM		Mylan
April 30, 1992ANDA073552 Betamethasone dipropionate
BETAMETHASONE DIPROPIONATE		Sun Pharma Canada
January 24, 1992ANDA073457 Atenolol
ATENOLOL		Mylan
October 31, 1991ANDA072926 Lorazepam
LORAZEPAM		Watson Labs
October 31, 1991ANDA072927 Lorazepam
LORAZEPAM		Watson Labs
October 31, 1991ANDA072928 Lorazepam
LORAZEPAM		Watson Labs
February 1, 1989ANDA072637 Albuterol sulfate
ALBUTEROL SULFATE		Sun Pharm Industries
November 14, 1988ANDA071826 Minoxidil
MINOXIDIL		Ph Health
November 14, 1988ANDA071839 Minoxidil
MINOXIDIL		Ph Health
April 5, 1988ANDA071881 Verapamil hydrochloride
VERAPAMIL HYDROCHLORIDE		Heritage
December 8, 1987ANDA071251 Triamterene and hydrochlorothiazide
TRIAMTERENE AND HYDROCHLOROTHIAZIDE		Apotex Inc
November 2, 1987ANDA088088 Isosorbide dinitrate
ISOSORBIDE DINITRATE		Hikma
July 14, 1987ANDA089399 Amitriptyline hydrochloride
AMITRIPTYLINE HYDROCHLORIDE		Sun Pharm Inds Inc
August 25, 1986ANDA071017 Sulfamethoxazole and trimethoprim
SULFAMETHOXAZOLE AND TRIMETHOPRIM		Sun Pharm Industries
July 16, 1986ANDA070772 Metronidazole
METRONIDAZOLE		Innogenix
November 19, 1985ANDA070213 Propranolol hydrochloride
PROPRANOLOL HYDROCHLORIDE		Mylan
April 3, 1985ANDA088803 Lidocaine
LIDOCAINE HYDROCHLORIDE		Hikma
September 11, 1984ANDA062505 Doxycycline
DOXYCYCLINE HYCLATE		Chartwell
August 17, 1981ANDA086724 Lidocaine
LIDOCAINE		Sun Pharma Canada
October 29, 1979ANDA086988 Methocarbamol
METHOCARBAMOL		Prinston Inc
December 1, 1978ANDA084903 Primidone
PRIMIDONE		Lannett
July 19, 1978ANDA084612 Dexamethasone
DEXAMETHASONE		Hikma
February 26, 1974ANDA083677 Prednisone
PREDNISONE		Mylan
—ANDA080292 Prednisone—
—ANDA088832 Prednisone—

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

Recall timeline

2024

  1. February 14, 2024 · Class II · Ongoing · D-0349-2024 · Fluticasone propionate

    CGMP Deviations:Suspected potential presence of Burkholderia cepacia complex

    Fluticasone Propionate Nasal Spray USP, 50 mcg per spray, 120 metered sprays, 16 g net fill, Rx only, Manufactured by: Apotek Inc., Toronto, Ontario, Cananda, Marketed by: GSMS Incorporated, Camarillo, CA, NDC 60429-195-

2023

  1. November 10, 2023 · Class II · Terminated · D-0129-2024 · Paroxetine

    Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out of specification results for the excipient Amadori Glucose adduct of Paroxetine

    PAROXETINE tablets, USP, 20 mg, Packaged as a) 90-count bottle NDC 60429-735-90; b)1000-count bottle, NDC 60429-735-10; Rx Only, Manufactured by Apotex, Inc., Toronto, Ontario, Canada, M9L 1T9, Packaged by GSMS, Incorpor

  2. November 10, 2023 · Class II · Terminated · D-0130-2024 · Paroxetine

    Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out of specification results for the excipient Amadori Glucose adduct of Paroxetine

    PAROXETINE tablets, USP, 40 mg, Packaged as a) 30-count bottle, NDC 60429-737-30; b) 90-count bottle NDC 60429-737-90; c)1000-count bottle, NDC 60429-737-10; Rx Only, Manufactured by Apotex, Inc., Toronto, Ontario, Canad

  3. November 10, 2023 · Class II · Terminated · D-0128-2024 · Paroxetine

    Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out of specification results for the excipient Amadori Glucose adduct of Paroxetine

    PAROXETINE tablets, USP, 10 mg, Packaged as a) 30-count bottle, NDC 60429-734-30; b) 90-count bottle NDC 60429-734-90; c)1000-count bottle, NDC 60429-734-10; Rx Only, Manufactured by Apotex, Inc., Toronto, Ontario, Canad

2022

  1. September 29, 2022 · Class I · Terminated · D-0019-2023 · Atenolol

    Label Mix - up; a bottle labeled as Atenolol 25mg Tablets contained Clopidogrel 75mg Tablets

    Atenolol Tablets, USP, 25 mg, 1000-count bottle, Rx only, Manufactured by: ALPHAPHARM PTY LTD, Marketed by: GSMS, Incorporated, Camarillo, CA 93012, USA, NDC 60429-027-10

  2. March 16, 2022 · Class II · Ongoing · D-1179-2022 · Enalapril maleate

    CGMP Deviations

    Enalapril Maleate Tablets, USP; 10 mg; 90 tablets, NDC 60429-185-90; manufactured by Taro Pharmaceutical Industries, Ltd.; packaged by GSMS, Incorporated, CA.

  3. March 16, 2022 · Class II · Ongoing · D-1178-2022 · Enalapril maleate

    CGMP Deviations

    Enalapril Maleate Tablets, USP; 5 mg; 90 tablets, NDC 60429-184-90; manufactured by Taro Pharmaceutical Industries, Ltd.; packaged by GSMS, Incorporated, CA.

  4. March 16, 2022 · Class II · Ongoing · D-1180-2022 · Enalapril maleate

    CGMP Deviations

    Enalapril Maleate Tablets, USP; 20 mg; 90 tablets, NDC 60429-186-90; manufactured by Taro Pharmaceutical Industries, Ltd.; packaged by GSMS, Incorporated, CA.

  5. March 16, 2022 · Class II · Ongoing · D-1177-2022 · Enalapril maleate

    CGMP Deviations

    Enalapril Maleate Tablets, USP; 2.5 mg; 90 tablets, NDC 60429-183-90; manufactured by Taro Pharmaceutical Industries, Ltd.; packaged by GSMS, Incorporated, CA, USA.

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

  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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