Medical emergency?Emergency? Call 911. Nearest emergency roomsNearest ERs

Español Near me My list Help
US Patient GuideUSA
Surprise me
Drug company (FDA labeler)

AvPAK

NDC labeler code: 50268

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

155Prescription medicines
322Products (NDC)
178FDA applications
11Recalls

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
September 18, 2025ANDA219904 Acamprosate calcium
ACAMPROSATE CALCIUM		Bionpharma
July 16, 2025ANDA213748 Sacubitril and valsartan
SACUBITRIL AND VALSARTAN		Msn
May 22, 2024ANDA213879 Dabigatran etexilate
DABIGATRAN ETEXILATE MESYLATE		Msn
February 16, 2024ANDA218221 Carbamazepine
CARBAMAZEPINE		Bionpharma
September 25, 2023ANDA218149 Methimazole
METHIMAZOLE		Bionpharma
February 9, 2023ANDA215243 Ramelteon
RAMELTEON		Micro Labs
December 27, 2022ANDA217054 Dicyclomine hydrochloride
DICYCLOMINE HYDROCHLORIDE		Twi Pharms
April 7, 2022ANDA212500 Posaconazole
POSACONAZOLE		DR Reddys
March 17, 2022ANDA208308 Lacosamide
LACOSAMIDE		Regcon Holdings
February 8, 2022ANDA214982 Digoxin
DIGOXIN		Aurobindo Pharma Ltd
January 11, 2022ANDA215939 Oxcarbazepine
OXCARBAZEPINE		Annora Pharma
October 22, 2021ANDA215579 Loperamide hydrochloride
LOPERAMIDE HYDROCHLORIDE		Bionpharma
July 15, 2021ANDA214242 Mesalamine
MESALAMINE		Alkem Labs Ltd
May 19, 2021ANDA214548 Amitriptyline hydrochloride
AMITRIPTYLINE HYDROCHLORIDE		Unichem
January 7, 2021ANDA214534 Fluphenazine hydrochloride
FLUPHENAZINE HYDROCHLORIDE		DR Reddys
November 30, 2020ANDA209953 Ranolazine
RANOLAZINE		Alkem Labs Ltd
October 16, 2020ANDA214295 Ursodiol
URSODIOL		Zydus Lifesciences
October 1, 2020ANDA207401 Acetazolamide
ACETAZOLAMIDE		Micro Labs Ltd India
May 18, 2020ANDA208416 Abiraterone acetate
ABIRATERONE ACETATE		DR Reddys
April 7, 2020ANDA208596 Ticagrelor
TICAGRELOR		Msn
December 2, 2019ANDA209356 Sucralfate
SUCRALFATE		Amneal
August 1, 2019ANDA212172 Methenamine hippurate
METHENAMINE HIPPURATE		Micro Labs
July 19, 2019ANDA209357 Pregabalin
PREGABALIN		Msn
July 8, 2019ANDA212277 Venlafaxine hydrochloride
VENLAFAXINE HYDROCHLORIDE		Annora Pharma
July 2, 2019ANDA210201 Misoprostol
MISOPROSTOL		Acq Pharma
April 17, 2019ANDA208250 Azithromycin
AZITHROMYCIN		Cspc Ouyi
January 14, 2019ANDA203561 Hydrochlorothiazide
HYDROCHLOROTHIAZIDE		Sciegen Pharms
November 23, 2018ANDA211659 Baclofen
BACLOFEN		Zydus Lifesciences
November 5, 2018ANDA207402 Clindamycin
CLINDAMYCIN HYDROCHLORIDE		Micro Labs
October 31, 2018ANDA209587 Butalbital, acetaminophen and caffeine
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE		Lgm Pharma
October 16, 2018ANDA211301 Ursodiol
URSODIOL		Amneal Pharms Co
October 12, 2018ANDA210742 Chlorthalidone
CHLORTHALIDONE		Appco
September 10, 2018ANDA209755 Chlorpromazine hydrochloride
CHLORPROMAZINE HYDROCHLORIDE		Amneal Pharms Co
July 19, 2018ANDA210041 Potassium chloride
POTASSIUM CHLORIDE		Amneal
May 1, 2018ANDA210441 Hydroxychloroquine sulfate
HYDROXYCHLOROQUINE SULFATE		Appco
April 30, 2018ANDA209226 Cinacalcet
CINACALCET HYDROCHLORIDE		Strides Pharma
January 26, 2018ANDA090742 Tenofovir disoproxil fumarate
TENOFOVIR DISOPROXIL FUMARATE		Strides Pharma
November 28, 2017ANDA207288 Sevelamer carbonate
SEVELAMER CARBONATE		Amneal Pharms Co
November 20, 2017ANDA209734 Acetazolamide
ACETAZOLAMIDE		Strides Pharma
October 26, 2017ANDA207057 Gabapentin
GABAPENTIN		Cspc Ouyi
October 18, 2017ANDA209724 Bumetanide
BUMETANIDE		Amneal Pharms Co
October 10, 2017ANDA205253 Trazodone hydrochloride
TRAZODONE HYDROCHLORIDE		Zydus Pharms
August 11, 2017ANDA207405 Tamsulosin hydrochloride
TAMSULOSIN HYDROCHLORIDE		Alkem Labs Ltd
July 7, 2017ANDA204652 Flucytosine
FLUCYTOSINE		Novel Labs Inc
June 12, 2017ANDA208803 Ezetimibe
EZETIMIBE		Amneal Pharms Co
May 30, 2017ANDA078983 Atomoxetine
ATOMOXETINE HYDROCHLORIDE		Apotex
April 6, 2017ANDA090693 Bupropion
BUPROPION HYDROCHLORIDE		Lupin
January 13, 2017ANDA207812 Methotrexate
METHOTREXATE SODIUM		Zydus Pharms
October 31, 2016ANDA207616 Rosuvastatin
ROSUVASTATIN CALCIUM		Hetero Labs Ltd V
September 28, 2016ANDA204711 Colchicine
COLCHICINE		Amneal Pharms
September 26, 2016ANDA205080 Itraconazole
ITRACONAZOLE		Amneal Pharms
August 8, 2016ANDA206654 Voriconazole
VORICONAZOLE		Prinston Inc
July 28, 2016ANDA204467 Allopurinol
ALLOPURINOL		Regcon Holdings
April 8, 2016ANDA208206 Raloxifene hydrochloride
RALOXIFENE HYDROCHLORIDE		Amneal Pharms
March 18, 2016ANDA205166 Valganciclovir
VALGANCICLOVIR HYDROCHLORIDE		Hetero Labs Ltd V
February 18, 2016ANDA205115 Doxycycline
DOXYCYCLINE		Zydus Pharms
January 29, 2016ANDA201760 Buprenorphine
BUPRENORPHINE HYDROCHLORIDE		Sun Pharm
October 26, 2015ANDA203179 Calcium acetate
CALCIUM ACETATE		Mpp Pharma
October 13, 2015ANDA200022 Memantine hydrochloride
MEMANTINE HYDROCHLORIDE		Unichem
September 25, 2015ANDA078279 Esomeprazole
ESOMEPRAZOLE MAGNESIUM		DR Reddys
August 21, 2015ANDA204519 Celecoxib
CELECOXIB		Alembic
July 31, 2015ANDA203346 Alprazolam
ALPRAZOLAM		Aurobindo Pharma
July 24, 2015ANDA203578 Niacin
NIACIN		Amneal Pharms
June 19, 2015ANDA203437 Entacapone
ENTACAPONE		Aurobindo Pharma Ltd
May 29, 2015ANDA203730 Divalproex sodium
DIVALPROEX SODIUM		Amneal Pharms
April 28, 2015ANDA205064 Aripiprazole
ARIPIPRAZOLE		Hetero Labs Ltd V
January 5, 2015ANDA203311 Valsartan
VALSARTAN		Hetero Labs Ltd V
October 27, 2014ANDA201578 Sirolimus
SIROLIMUS		DR Reddys
September 15, 2014ANDA204165 Clopidogrel
CLOPIDOGREL BISULFATE		Sciegen Pharms
September 10, 2014ANDA202843 Montelukast
MONTELUKAST SODIUM		Hetero Labs Ltd V
September 10, 2014ANDA202882 Pantoprazole sodium
PANTOPRAZOLE SODIUM		Hetero Labs Ltd V
March 18, 2014ANDA202960 Atovaquone
ATOVAQUONE		Amneal Pharms
March 4, 2014ANDA202632 Moxifloxacin
MOXIFLOXACIN HYDROCHLORIDE		Aurobindo Pharma Ltd
February 7, 2014ANDA078888 Buspirone
BUSPIRONE HYDROCHLORIDE		Zydus Pharms
January 8, 2014ANDA201676 Sirolimus
SIROLIMUS		Zydus Pharms
September 13, 2013ANDA091560 Abacavir
ABACAVIR SULFATE		Hetero Labs Ltd III
June 21, 2013ANDA203399 Metaxalone
METAXALONE		Amneal Pharms
June 13, 2013ANDA200197 Mycophenolate mofetil
MYCOPHENOLATE MOFETIL		Alkem Labs Ltd
April 15, 2013ANDA202675 Glycopyrrolate
GLYCOPYRROLATE		Aurobindo Pharma
February 28, 2013ANDA202025 Sildenafil
SILDENAFIL CITRATE		Amneal Pharms
February 22, 2013ANDA202128 Potassium chloride
POTASSIUM CHLORIDE		Amneal Pharms
February 22, 2013ANDA203136 Buprenorphine and naloxone
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE		Amneal Pharms
February 12, 2013ANDA201504 Quetiapine
QUETIAPINE FUMARATE		Alkem Labs Ltd
September 27, 2012ANDA202566 Modafinil
MODAFINIL		Aurobindo Pharma Ltd
August 15, 2012ANDA078889 Metoprolol
METOPROLOL SUCCINATE		Reddys
August 3, 2012ANDA200405 Montelukast
MONTELUKAST SODIUM		Lannett Co Inc
August 1, 2012ANDA090617 Metoprolol
METOPROLOL SUCCINATE		DR Reddys Labs Ltd
July 25, 2012ANDA065489 Clarithromycin
CLARITHROMYCIN		Aurobindo
May 29, 2012ANDA090548 Atorvastatin
ATORVASTATIN CALCIUM		Apotex Inc
March 2, 2012ANDA077561 Ziprasidone
ZIPRASIDONE HYDROCHLORIDE		Apotex
December 23, 2011ANDA090856 Fenofibrate
FENOFIBRATE		Lupin Ltd
November 25, 2011ANDA078986 Carbamazepine
CARBAMAZEPINE		Apotex Inc
November 4, 2011ANDA091249 Mycophenolate mofetil
MYCOPHENOLATE MOFETIL		Alkem Labs Ltd
June 3, 2011ANDA200161 Letrozole
LETROZOLE		Natco Pharma Ltd
April 12, 2011ANDA091240 Indomethacin
INDOMETHACIN		Hetero Labs Ltd III
February 23, 2011ANDA201451 Meclizine hydrochloride
MECLIZINE HYDROCHLORIDE		Amneal Pharms
January 31, 2011ANDA091483 Ondansetron
ONDANSETRON HYDROCHLORIDE		Amneal Pharms
January 20, 2011ANDA078281 Pantoprazole sodium
PANTOPRAZOLE SODIUM		Lannett Co Inc
December 20, 2010ANDA090836 Cephalexin
CEPHALEXIN		Alkem Labs Ltd
October 6, 2010ANDA078243 Losartan potassium
LOSARTAN POTASSIUM		Zydus Pharms USA Inc
August 3, 2010ANDA090455 Ergocalciferol
ERGOCALCIFEROL		Onesource
July 23, 2010ANDA090478 Cyclobenzaprine hydrochloride
CYCLOBENZAPRINE HYDROCHLORIDE		Invagen Pharms
June 28, 2010ANDA079220 Anastrozole
ANASTROZOLE		Natco Pharma Ltd
June 7, 2010ANDA090061 Finasteride
FINASTERIDE		Hetero Labs Ltd III
May 24, 2010ANDA090682 Valacyclovir
VALACYCLOVIR HYDROCHLORIDE		Aurobindo Pharma
May 12, 2010ANDA090509 Tacrolimus
TACROLIMUS		DR Reddys Labs Ltd
February 16, 2010ANDA090624 Sulfamethoxazole and trimethoprim
SULFAMETHOXAZOLE AND TRIMETHOPRIM		Aurobindo Pharma
December 9, 2009ANDA090485 Tramadol hydrochloride and acetaminophen
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN		Amneal Pharms
November 13, 2009NDA022430 Tranexamic acid
LYSTEDA		J Molner
November 6, 2009ANDA090200 Methocarbamol
METHOCARBAMOL		Hetero Labs Ltd III
August 26, 2009ANDA078895 Clonidine
CLONIDINE HYDROCHLORIDE		Unichem
April 17, 2009ANDA078490 Omeprazole
OMEPRAZOLE		DR Reddys Labs Ltd
March 27, 2009ANDA078235 Topiramate
TOPIRAMATE		Zydus Pharms USA Inc
March 13, 2009ANDA079067 Metronidazole
METRONIDAZOLE		Alembic Pharms Ltd
February 4, 2009ANDA078503 Oxybutynin
OXYBUTYNIN CHLORIDE		Osmotica Pharm Us
January 27, 2009ANDA079234 Torsemide
TORSEMIDE		Hetero Labs Ltd III
October 7, 2008ANDA077731 Fluconazole
FLUCONAZOLE		Aurobindo Pharma
May 29, 2008ANDA078720 Amantadine
AMANTADINE HYDROCHLORIDE		Bionpharma
May 5, 2008ANDA078110 Ropinirole
ROPINIROLE HYDROCHLORIDE		Prinston Inc
April 23, 2008ANDA040866 Primidone
PRIMIDONE		Amneal Pharm
April 17, 2008ANDA078321 Metformin hydrochloride
METFORMIN HYDROCHLORIDE		Cspc Ouyi
March 26, 2008ANDA076509 Fenofibrate
FENOFIBRATE		Impax Labs
December 28, 2007ANDA077883 Balsalazide disodium
BALSALAZIDE DISODIUM		Apotex
November 27, 2007ANDA040777 Oxycodone and acetaminophen
OXYCODONE AND ACETAMINOPHEN		Amneal Pharms
November 27, 2007ANDA040778 Oxycodone and acetaminophen
OXYCODONE AND ACETAMINOPHEN		Amneal Pharms Ny
July 31, 2007ANDA078539 Ondansetron
ONDANSETRON HYDROCHLORIDE		Aurobindo Pharma
July 25, 2007ANDA078406 Paroxetine
PAROXETINE HYDROCHLORIDE		Aurobindo Pharma
March 30, 2007ANDA040646 Hydrocortisone
HYDROCORTISONE		Impax Labs Inc
February 6, 2007ANDA077670 Sertraline hydrochloride
SERTRALINE HYDROCHLORIDE		Lupin
December 27, 2006ANDA077910 Bisoprolol fumarate
BISOPROLOL FUMARATE		Aurobindo Pharma
December 7, 2006ANDA077918 Meloxicam
MELOXICAM		Yung Shin Pharm
October 23, 2006ANDA076341 Pravastatin sodium
PRAVASTATIN SODIUM		Apotex
September 12, 2006ANDA077746 Midodrine hydrochloride
MIDODRINE HYDROCHLORIDE		Apotex
September 5, 2006ANDA040684 Phenytoin
EXTENDED PHENYTOIN SODIUM		Taro
August 25, 2006ANDA040736 Hydrocodone bitartrate and acetaminophen
HYDROCODONE BITARTRATE AND ACETAMINOPHEN		Amneal Pharms Ny
August 25, 2006ANDA040746 Hydrocodone bitartrate and acetaminophen
HYDROCODONE BITARTRATE AND ACETAMINOPHEN		Amneal Pharms Ny
July 27, 2006ANDA077836 Gemfibrozil
GEMFIBROZIL		Invagen Pharms
June 28, 2006ANDA077856 Clonazepam
CLONAZEPAM		Prinston Inc
May 31, 2006ANDA077869 Zonisamide
ZONISAMIDE		Invagen Pharms
February 3, 2006ANDA076820 Benazepril hydrochloride
BENAZEPRIL HYDROCHLORIDE		Amneal Pharms
January 17, 2006ANDA076143 Bupropion
BUPROPION HYDROCHLORIDE		Apotex
November 21, 2005ANDA077127 Nifedipine
NIFEDIPINE		Osmotica Pharm Us
October 14, 2005ANDA077220 Pilocarpine hydrochloride
PILOCARPINE HYDROCHLORIDE		Lannett Co Inc
October 6, 2005ANDA077091 Glimepiride
GLIMEPIRIDE		DR Reddys Labs Ltd
September 23, 2005ANDA065170 Mupirocin
MUPIROCIN		Sun Pharma Canada
September 13, 2005ANDA077090 Leflunomide
LEFLUNOMIDE		Apotex
March 1, 2005ANDA076856 Dantrolene sodium
DANTROLENE SODIUM		Impax Labs
December 20, 2004ANDA075317 Terazosin hydrochloride
TERAZOSIN HYDROCHLORIDE		Jubilant Cadista
December 10, 2004ANDA077030 Cilostazol
CILOSTAZOL		Apotex
September 30, 2003ANDA040537 Cyproheptadine
CYPROHEPTADINE HYDROCHLORIDE		Mountain
September 26, 2002ANDA076140 Sotalol hydrochloride
SOTALOL HYDROCHLORIDE		Apotex
July 3, 2002ANDA076286 Tizanidine
TIZANIDINE HYDROCHLORIDE		DR Reddys Labs Inc
March 18, 2002ANDA040431 Fludrocortisone acetate
FLUDROCORTISONE ACETATE		Impax Labs
December 18, 2001ANDA075927 Naproxen
NAPROXEN		Amneal Pharms Ny
July 31, 2001ANDA075442 Flecainide acetate
FLECAINIDE ACETATE		Amneal Pharm
June 13, 2001ANDA075795 Glipizide
GLIPIZIDE		Apotex
April 16, 2001ANDA075718 Famotidine
FAMOTIDINE		DR Reddys Labs Ltd
April 16, 2001ANDA075805 Famotidine
FAMOTIDINE		Carlsbad
January 25, 2001ANDA075389 Amiodarone hydrochloride
AMIODARONE HYDROCHLORIDE		DR Reddys Labs SA
October 18, 2000ANDA075580 Doxazosin
DOXAZOSIN MESYLATE		Apotex
December 30, 1999ANDA075047 Acebutolol hydrochloride
ACEBUTOLOL HYDROCHLORIDE		Amneal Pharm
April 30, 1999ANDA075382 Acyclovir
ACYCLOVIR		Carlsbad
December 24, 1998ANDA075060 Amantadine
AMANTADINE HYDROCHLORIDE		Pharmobedient
November 25, 1998ANDA075109 Guanfacine
GUANFACINE HYDROCHLORIDE		Amneal Pharm
February 27, 1998ANDA040268 Prochlorperazine
PROCOMP		Jubilant Cadista
July 15, 1996ANDA040156 Hydroxyzine
HYDROXYZINE PAMOATE		Impax Labs Inc
January 28, 1993ANDA073652 Nitrofurantoin
NITROFURANTOIN		Impax Labs Inc
January 28, 1993ANDA073671 Nitrofurantoin
NITROFURANTOIN		Impax Labs Inc
August 28, 1992ANDA073589 Carbidopa and levodopa
CARBIDOPA AND LEVODOPA		DR Reddys Labs SA
April 6, 1988ANDA071972 Propranolol hydrochloride
PROPRANOLOL HYDROCHLORIDE		Impax Labs Inc
October 2, 1987ANDA087537 Isosorbide dinitrate
ISOSORBIDE DINITRATE		Ph Health
April 21, 1987ANDA071456 Temazepam
TEMAZEPAM		Novel Labs Inc
April 21, 1987ANDA071457 Temazepam
TEMAZEPAM		Novel Labs Inc
March 12, 1987ANDA086923 Isosorbide dinitrate
ISOSORBIDE DINITRATE		Ph Health
March 12, 1987ANDA086925 Isosorbide dinitrate
ISOSORBIDE DINITRATE		Ph Health
July 10, 1986ANDA062676 Doxycycline
DOXYCYCLINE HYCLATE		Sun Pharm Industries
July 10, 1986ANDA062677 Doxycycline
DOXYCYCLINE HYCLATE		Sun Pharm Industries
—ANDA077410 Nifedipine—

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

Recall timeline

2026

  1. February 13, 2026 · Class II · Ongoing · D-0341-2026 · Amantadine

    Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution.

    Amantadine HCl, Capsules, UPS, 100 mg, 50 Capsules (5 x 10) unit dose, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478, www.avkare.com, NDC 50268-069-15.

2025

  1. December 31, 2025 · Class II · Ongoing · D-0292-2026 · Rosuvastatin

    Out of specification for dissolution.

    Rosuvastatin Tablets, USP, 10 mg, Rx Only, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 50268-709-15

  2. August 25, 2025 · Class II · Ongoing · D-0644-2025 · Chlorpromazine hydrochloride

    Presence of a foreign substance.

    chloroproMAZINE Hydrochloride Tablets, USP, 100 mg, 50 Tablets (5x10) unit dose carton, Rx only, Manufactured for: AvKare, Pulaski, TN, 38478, NDC 50268-165-15

  3. August 25, 2025 · Class II · Ongoing · D-0643-2025 · Chlorpromazine hydrochloride

    Presence of a foreign substance.

    chloroproMAZINE Hydrochloride Tablets, USP, 50 mg, 50 Tablets (5x10) unit dose carton, Rx only, Manufactured for: AvKare, Pulaski, TN, 38478, NDC 50268-164-15

  4. May 13, 2025 · Class II · Ongoing · D-0460-2025 · Celecoxib

    Presence of Foreign Tablets/Capsules: manufacturer recalled because one tadalafil 5mg tablet was found in 500 count bottle of Celecoxib 200 mg capsules

    Celecoxib Capsules, 200 mg, 50 Capsules (5x10) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 50268-169-15

  5. May 9, 2025 · Class II · Ongoing · D-0461-2025 · Chlorthalidone

    Failed Dissolution Specifications

    Chlorthalidone Tablets, USP, 25 mg, 50 Tablets (5x10) Unit Dose cards per carton, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 50268-167-15

2023

  1. June 13, 2023 · Class III · Ongoing · D-0875-2023 · Tranexamic acid

    Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.

    Tranexamic Acid USP Tablets, 650 mg, 30 tablets (3X10) Unit Dose, Rx Only, Manufactured for: AvKARE Pulaski, TN 38478, NDC 50268-772-13

2022

  1. December 22, 2022 · Class II · Completed · D-0091-2023 · Glycopyrrolate

    Failed impurities/degradation specifications: Out of specification for unknown impurities.

    Glycopyrrolate Tablets, USP, 1 mg, 50 Tablets (5x10) Unit Dose carton, Rx Only, Manufactured for: AvKARE Pulaski, TN 38478, NDC 50268-363-15

  2. April 13, 2022 · Class II · Terminated · D-1037-2022 · Meclizine hydrochloride

    cGMP deviations: Temperature abuse

    Meclizine Hydrochloride Tablets, USP, 25 mg, 50-count cartons (5 x10 unit dose), 10 Tablets per card, 5 cards per carton, Rx only, MFG: Avkare Inc., NDC 50268-523-15

2018

  1. March 30, 2018 · Class II · Terminated · D-0633-2018 · Amantadine

    Failed Dissolution Specifications

    Amantadine HCl Capsules, USP, 100 mg, 50 Capsules (5x10) Unite Dose, Rx Only, Manufactured for: AvKARE Inc. Pulaski, TN 38478 --- NDC 50268-069-15

  2. February 9, 2018 · Class II · Terminated · D-0544-2018 · Acyclovir

    Presence of Foreign Tablet/Capsule; cartons labeled to contain Acyclovir tablets may contain Torsemide tablets in some of the blister cavities.

    Acyclovir Tablets, USP, 400 mg, 50 Tablets (5 x 10) unit dose blisters [NDC 50268-061-11] per carton [NDC 50268-061-15], 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

  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 →