NorthStar RxLLC
NDC labeler codes: 16714, 72603
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
- LevothyroxineTirosint, Tirosint Sol, Synthroid · 11 products
- Heparin sodiumHeparin Sodium and Dextrose · 8 products
- AtorvastatinLipitor · 8 products
- LidocaineXylocaine Mpf, Xylocaine, Lidocaine Viscous · 7 products
- PregabalinLyrica, Lyrica CR · 7 products
- AtomoxetineStrattera, Atoncy · 7 products
- AripiprazoleAbilify, Opipza, Abilify Asimtufii · 7 products
- OlanzapineZyprexa, Zyprexa Zydis, Olanzapine Intramuscular · 7 products
- Enoxaparin sodiumLovenox · 7 products
- Bupivacaine hydrochlorideSensorcaine Mpf, Marcaine, Sensorcaine · 6 products
- Triamcinolone acetonideKenalog-40, Triderm, Triesence · 6 products
- Pramipexole dihydrochloride6 products
- DasatinibSprycel, Phyrago · 6 products
- Enalapril maleateVasotec, Epaned · 5 products
- LacosamideVimpat, Motpoly XR · 5 products
- Doxepin hydrochlorideSilenor, Prudoxin, Zonalon · 5 products
- Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfateAdderall, Mixed Salts of a Single Entity Amphetamine Product XR, Adderall XR · 5 products
- TopiramateTopamax, Qudexy XR, Trokendi XR · 5 products
- EverolimusYulithira, Zortress, Afinitor · 4 products
- NebivololBystolic · 4 products
- TadalafilCialis, Tadliq, Adcirca · 4 products
- PaliperidoneInvega · 4 products
- Pravastatin sodium4 products
- RosuvastatinCrestor · 4 products
- Lurasidone hydrochlorideLatuda · 4 products
- CelecoxibCelebrex, Vyscoxa, Elyxyb - Celecoxib · 4 products
- GuanfacineIntuniv · 4 products
- CarvedilolCoreg, Coreg CR · 4 products
- LevetiracetamKeppra, Spritam, Keppra XR · 4 products
- Sapropterin dihydrochlorideKuvan, Javygtor, Zelvysia · 3 products
- OxcarbazepineTrileptal, Oxtellar XR · 3 products
- IrbesartanAvapro · 3 products
- Telmisartan3 products
- Midodrine hydrochloride3 products
- DofetilideTikosyn · 3 products
- Pantoprazole sodiumProtonix I.V., Protonix Delayed-Release, Pantoprazole Sodium I.V. · 3 products
- PioglitazoneActos · 3 products
- Nitrofurantoin3 products
- Olmesartan medoxomil and hydrochlorothiazideBenicar Hct · 3 products
- Hydroxyzine3 products
Show the other 65 medicines
- TobramycinTobramycin Inhalation Solution Pak, Tobi, Tobi Podhaler · 3 products
- Losartan potassiumLosortan Potassium, Cozaar, Arbli · 3 products
- Venlafaxine hydrochlorideEffexor XR · 3 products
- Repaglinide3 products
- Sacubitril and valsartanEntresto · 3 products
- EscitalopramLexapro · 3 products
- ClobazamSympazan, Onfi · 3 products
- TimololTimoptic in Ocudose, Timoptic-Xe, Timoptic · 3 products
- Olmesartan medoxomilBenicar · 3 products
- Memantine hydrochloride2 products
- OfloxacinOcuflox · 2 products
- PemetrexedPemrydi Rtu, Alimta, Pemfexy · 2 products
- FebuxostatUloric · 2 products
- PitavastatinZypitamag, Livalo · 2 products
- FenofibrateAntara, Lipofen, Tricor · 2 products
- Candesartan cilexetilAtacand · 2 products
- TicagrelorBrilinta · 2 products
- AllopurinolAloprim · 2 products
- RasagilineAzilect · 2 products
- BaclofenGablofen, Lyvispah, Baclofen (Intrathecal) · 2 products
- Doxorubicin hydrochlorideDoxil, Doxorubicin Hydrochloride Liposome · 2 products
- PhenylephrineBiorphen, Immphentiv · 2 products
- Fesoterodine fumarateToviaz · 2 products
- EntecavirBaraclude · 2 products
- DaptomycinDapzura Rt · 2 products
- Varenicline tartrateChantix, Tyrvaya · 2 products
- ZileutonZyflo · 1 product
- AtropineAtropen Auto-Injector, Isopto Atropine · 1 product
- Sodium sulfate, potassium sulfate, magnesium sulfateSuprep Bowel Prep, Sodium Sulfate, Potassium Sulfate, and Magnesium Sulfate Bowel Prep Kit · 1 product
- CyanocobalaminNascobal · 1 product
- Emtricitabine and tenofovir disoproxil fumarateTruvada · 1 product
- Ciprofloxacin and dexamethasone1 product
- Sumatriptan and naproxen sodiumTreximet · 1 product
- AtovaquoneMepron · 1 product
- Loteprednol etabonateLotemax, Lotemax Sm, Alrex · 1 product
- Thiamine hydrochloride1 product
- Naloxone hydrochlorideNarcan, Rextovy, Zimhi · 1 product
- ClopidogrelPlavix · 1 product
- FosaprepitantFocinvez, Emend, Navitrux · 1 product
- ValganciclovirValcyte · 1 product
- Fluocinonide1 product
- Ertapenem sodiumInvanz · 1 product
- Clindamycin phosphate and benzoyl peroxideOnexton, Acanya, Neuac · 1 product
- IndomethacinIndocin · 1 product
- PosaconazoleNoxafil · 1 product
- Tenofovir disoproxil fumarateViread · 1 product
- BortezomibBoruzu, Velcade · 1 product
- GlycopyrrolateGlyrx-Pf, Glycate, Cuvposa · 1 product
- NitroglycerinNitrostat, Nitro-Dur, Nitroglycerin in Dextrose · 1 product
- MesalaminePentasa, Lialda, Mesalamine Rectal · 1 product
- Sevelamer carbonateRenvela · 1 product
- Clobetasol propionateClobetasol Propionate (Emollient), Byqlovi, Tovet (Emollient Formulation) · 1 product
- Brimonidine tartrate and timolol maleateCombigan · 1 product
- Ephedrine sulfateEmerphed Pfs, Akovaz, Emerphed · 1 product
- Dabigatran etexilatePradaxa · 1 product
- GemfibrozilLopid · 1 product
- ItraconazoleTolsura, Sporanox · 1 product
- Nitrofurantoin (monohydrate/macrocrystals)Macrobid, Nitrofurantoin Monohydrate Macrocrystalline, Nitrofurantoin Mono · 1 product
- Haloperidol decanoate1 product
- CapecitabineXeloda · 1 product
- RivaroxabanXarelto · 1 product
- Arformoterol tartrate1 product
- RufinamideBanzel · 1 product
- Formoterol fumaratePerforomist · 1 product
- AzacitidineOnureg, Vidaza · 1 product
FDA applications for these products
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| November 6, 2025 | ANDA216261 | Dasatinib DASATINIB | Alembic |
| October 28, 2025 | ANDA212258 | Ticagrelor TICAGRELOR | Macleods Pharms |
| July 3, 2025 | ANDA216905 | Indomethacin INDOMETHACIN | Annora Pharma |
| May 14, 2025 | ANDA213114 | Rivaroxaban RIVAROXABAN | Macleods Pharms |
| January 28, 2025 | ANDA212661 | Nebivolol NEBIVOLOL HYDROCHLORIDE | Macleods Pharms |
| January 15, 2025 | ANDA203986 | Telmisartan TELMISARTAN | Macleods Pharms |
| November 6, 2024 | ANDA218471 | Thiamine hydrochloride THIAMINE HYDROCHLORIDE | Aspiro |
| October 18, 2024 | ANDA212903 | Sodium sulfate, potassium sulfate, magnesium sulfate SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE | Annora Pharma |
| October 16, 2024 | ANDA213728 | Sacubitril and valsartan SACUBITRIL AND VALSARTAN | Macleods Pharms |
| July 10, 2024 | ANDA217839 | Cyanocobalamin CYANOCOBALAMIN | Mankind Pharma |
| June 6, 2024 | ANDA217767 | Venlafaxine hydrochloride VENLAFAXINE HYDROCHLORIDE | Alembic |
| April 30, 2024 | ANDA205977 | Pitavastatin PITAVASTATIN CALCIUM | Hetero Labs Ltd V |
| April 25, 2024 | ANDA207291 | Sevelamer carbonate SEVELAMER CARBONATE | Macleods Pharms |
| March 27, 2024 | ANDA217821 | Bupivacaine hydrochloride BUPIVACAINE HYDROCHLORIDE | Aspiro |
| March 5, 2024 | ANDA210203 | Capecitabine CAPECITABINE | Hetero Labs Ltd V |
| February 29, 2024 | ANDA218404 | Naloxone hydrochloride NALOXONE HYDROCHLORIDE | Mankind Pharma |
| February 5, 2024 | ANDA216334 | Mesalamine MESALAMINE | Annora Pharma |
| January 9, 2024 | ANDA204792 | Fesoterodine fumarate FESOTERODINE FUMARATE | Hetero Labs Ltd V |
| January 8, 2024 | ANDA218148 | Atropine ATROPINE SULFATE | Mankind Pharma |
| January 5, 2024 | ANDA217081 | Atorvastatin ATORVASTATIN CALCIUM | Mankind Pharma |
| December 28, 2023 | ANDA215990 | Clobetasol propionate CLOBETASOL PROPIONATE | Macleods Pharms |
| December 5, 2023 | ANDA216841 | Rufinamide RUFINAMIDE | Hetero Labs Ltd III |
| December 5, 2023 | ANDA217970 | Nitroglycerin NITROGLYCERIN | Mankind Pharma |
| November 1, 2023 | ANDA216150 | Aripiprazole ARIPIPRAZOLE | Hetero Labs Ltd III |
| November 1, 2023 | ANDA217271 | Midodrine hydrochloride MIDODRINE HYDROCHLORIDE | Mankind Pharma |
Show the other 100 applications
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| October 23, 2023 | ANDA214571 | Varenicline tartrate VARENICLINE TARTRATE | Hetero Labs Ltd III |
| October 20, 2023 | ANDA216749 | Oxcarbazepine OXCARBAZEPINE | Hetero Labs Ltd III |
| September 12, 2023 | ANDA214344 | Atorvastatin ATORVASTATIN CALCIUM | Hetero Labs Ltd V |
| July 11, 2023 | ANDA217357 | Nitrofurantoin (monohydrate/macrocrystals) NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | Mankind Pharma |
| June 30, 2023 | ANDA214478 | Tobramycin TOBRAMYCIN | Mankind Pharma |
| June 16, 2023 | ANDA217692 | Lidocaine LIDOCAINE HYDROCHLORIDE | Mankind Pharma |
| June 9, 2023 | ANDA212124 | Lurasidone hydrochloride LURASIDONE HYDROCHLORIDE | Macleods Pharms |
| June 1, 2023 | ANDA204801 | Olmesartan medoxomil and hydrochlorothiazide OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | Macleods Pharms |
| May 23, 2023 | ANDA216730 | Haloperidol decanoate HALOPERIDOL DECANOATE | Mankind Pharma |
| March 22, 2023 | ANDA207209 | Repaglinide REPAGLINIDE | Macleods Pharms |
| March 22, 2023 | ANDA215883 | Formoterol fumarate FORMOTEROL FUMARATE | Mankind Pharma |
| March 22, 2023 | ANDA217466 | Olanzapine OLANZAPINE | Aspiro |
| March 21, 2023 | ANDA217272 | Nitrofurantoin NITROFURANTOIN | Mankind Pharma |
| March 15, 2023 | ANDA205660 | Enoxaparin sodium ENOXAPARIN SODIUM (PRESERVATIVE FREE) | Shenzhen Techdow |
| January 11, 2023 | ANDA216496 | Phenylephrine PHENYLEPHRINE HYDROCHLORIDE | Mankind Pharma |
| December 23, 2022 | ANDA216445 | Daptomycin DAPTOMYCIN | Aspiro |
| December 21, 2022 | ANDA211417 | Levothyroxine LEVOTHYROXINE SODIUM | Macleods Pharms |
| December 8, 2022 | ANDA214321 | Posaconazole POSACONAZOLE | Hetero Labs Ltd III |
| November 23, 2022 | ANDA215886 | Ofloxacin OFLOXACIN | Mankind Pharma |
| November 15, 2022 | ANDA216128 | Arformoterol tartrate ARFORMOTEROL TARTRATE | Mankind Pharma |
| October 11, 2022 | ANDA215742 | Zileuton ZILEUTON | Annora Pharma |
| October 4, 2022 | ANDA201949 | Brimonidine tartrate and timolol maleate BRIMONIDINE TARTRATE AND TIMOLOL MALEATE | Regcon Holdings |
| October 4, 2022 | ANDA211475 | Valganciclovir VALGANCICLOVIR HYDROCHLORIDE | Hetero Labs Ltd V |
| September 29, 2022 | ANDA216859 | Phenylephrine PHENYLEPHRINE HYDROCHLORIDE | Mankind Pharma |
| September 23, 2022 | ANDA216413 | Daptomycin DAPTOMYCIN | Aspiro |
| September 22, 2022 | ANDA215733 | Timolol TIMOLOL MALEATE | DR Reddys |
| September 22, 2022 | ANDA216725 | Tobramycin TOBRAMYCIN | Mankind Pharma |
| September 14, 2022 | ANDA216335 | Lacosamide LACOSAMIDE | Aspiro |
| August 23, 2022 | ANDA215534 | Sapropterin dihydrochloride SAPROPTERIN DIHYDROCHLORIDE | Annora Pharma |
| August 18, 2022 | ANDA215420 | Sapropterin dihydrochloride SAPROPTERIN DIHYDROCHLORIDE | Annora Pharma |
| July 26, 2022 | ANDA202963 | Bortezomib BORTEZOMIB | DR Reddys |
| July 14, 2022 | ANDA216130 | Ofloxacin OFLOXACIN | Mankind Pharma |
| July 5, 2022 | ANDA213698 | Glycopyrrolate GLYCOPYRROLATE | Annora Pharma |
| May 25, 2022 | ANDA208696 | Pemetrexed PEMETREXED DISODIUM | Jiangsu Hansoh Pharm |
| April 14, 2022 | ANDA216129 | Ephedrine sulfate EPHEDRINE SULFATE | Mankind Pharma |
| March 17, 2022 | ANDA208308 | Lacosamide LACOSAMIDE | Regcon Holdings |
| February 24, 2022 | ANDA214467 | Enalapril maleate ENALAPRIL MALEATE | Annora Pharma |
| February 9, 2022 | ANDA215710 | Doxepin hydrochloride DOXEPIN HYDROCHLORIDE | Mankind Pharma |
| January 11, 2022 | ANDA215939 | Oxcarbazepine OXCARBAZEPINE | Annora Pharma |
| November 8, 2021 | ANDA214336 | Lidocaine LIDOCAINE HYDROCHLORIDE | Aspiro |
| July 29, 2021 | ANDA214616 | Fosaprepitant FOSAPREPITANT DIMEGLUMINE | Aspiro |
| March 26, 2021 | ANDA212040 | Ertapenem sodium ERTAPENEM SODIUM | Gland |
| March 11, 2021 | ANDA202682 | Atomoxetine ATOMOXETINE HYDROCHLORIDE | Hetero Labs Ltd V |
| February 26, 2021 | ANDA212450 | Loteprednol etabonate LOTEPREDNOL ETABONATE | Sun Pharm |
| February 11, 2021 | ANDA214182 | Everolimus EVEROLIMUS | Biocon Pharma |
| February 1, 2021 | ANDA210278 | Topiramate TOPIRAMATE | Glenmark Pharms Ltd |
| August 10, 2020 | ANDA205548 | Ciprofloxacin and dexamethasone CIPROFLOXACIN AND DEXAMETHASONE | DR Reddys |
| June 30, 2020 | ANDA213725 | Pantoprazole sodium PANTOPRAZOLE SODIUM | Sun Pharm |
| June 12, 2020 | ANDA213864 | Fenofibrate FENOFIBRATE | Mankind Pharma |
| May 15, 2020 | ANDA203442 | Emtricitabine and tenofovir disoproxil fumarate EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | Macleods Pharms |
| May 6, 2020 | ANDA207961 | Dabigatran etexilate DABIGATRAN ETEXILATE MESYLATE | Hetero Labs Ltd III |
| February 24, 2020 | ANDA209796 | Clobazam CLOBAZAM | Hetero Labs Ltd III |
| February 24, 2020 | ANDA211004 | Heparin sodium HEPARIN SODIUM | Emerge Bioscience |
| October 8, 2019 | ANDA206912 | Pregabalin PREGABALIN | Hetero Labs Ltd III |
| July 1, 2019 | ANDA205467 | Febuxostat FEBUXOSTAT | Sun Pharm |
| May 28, 2019 | ANDA211007 | Heparin sodium HEPARIN SODIUM | Emerge Bioscience |
| March 26, 2019 | ANDA208934 | Tadalafil TADALAFIL | Sun Pharm |
| March 14, 2019 | ANDA209252 | Clindamycin phosphate and benzoyl peroxide CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE | Glenmark Speclt |
| December 14, 2018 | ANDA211005 | Heparin sodium HEPARIN SODIUM | Emerge Bioscience |
| November 23, 2018 | ANDA209828 | Triamcinolone acetonide TRIAMCINOLONE ACETONIDE | Macleods Pharms |
| October 22, 2018 | ANDA209795 | Clobazam CLOBAZAM | Hetero Labs Ltd III |
| October 11, 2018 | ANDA210692 | Atovaquone ATOVAQUONE | Hetero Labs Ltd III |
| October 9, 2018 | ANDA210466 | Dofetilide DOFETILIDE | Sun Pharm |
| July 20, 2018 | ANDA202803 | Sumatriptan and naproxen sodium SUMATRIPTAN AND NAPROXEN SODIUM | Sun Pharm |
| July 9, 2018 | ANDA207080 | Tobramycin TOBRAMYCIN | DR Reddys Labs SA |
| May 18, 2018 | ANDA209535 | Triamcinolone acetonide TRIAMCINOLONE ACETONIDE | Macleods Pharms |
| April 23, 2018 | ANDA209283 | Fluocinonide FLUOCINONIDE | Macleods Pharms |
| April 6, 2018 | ANDA205618 | Paliperidone PALIPERIDONE | Sun Pharm |
| January 26, 2018 | ANDA090636 | Tenofovir disoproxil fumarate TENOFOVIR DISOPROXIL FUMARATE | Hetero Labs Ltd III |
| November 16, 2017 | ANDA205689 | Guanfacine GUANFACINE HYDROCHLORIDE | Sun Pharm |
| October 30, 2017 | ANDA201889 | Rasagiline RASAGILINE MESYLATE | Alkem Labs Ltd |
| October 25, 2017 | ANDA090132 | Carvedilol CARVEDILOL PHOSPHATE | Sun Pharm Industries |
| June 12, 2017 | ANDA208591 | Itraconazole ITRACONAZOLE | Alkem Labs Ltd |
| April 24, 2017 | ANDA204814 | Olmesartan medoxomil OLMESARTAN MEDOXOMIL | Macleods Pharms |
| December 6, 2016 | ANDA206872 | Entecavir ENTECAVIR | Cipla |
| December 5, 2016 | ANDA203813 | Candesartan cilexetil CANDESARTAN CILEXETIL | Macleods Pharms |
| July 28, 2016 | ANDA204467 | Allopurinol ALLOPURINOL | Regcon Holdings |
| July 19, 2016 | ANDA079172 | Rosuvastatin ROSUVASTATIN CALCIUM | Glenmark Speclt |
| June 24, 2016 | ANDA206156 | Pramipexole dihydrochloride PRAMIPEXOLE DIHYDROCHLORIDE | Macleods Pharms |
| September 23, 2015 | ANDA207446 | Celecoxib CELECOXIB | Cipla |
| August 12, 2015 | ANDA203835 | Losartan potassium LOSARTAN POTASSIUM | Hetero Labs Ltd V |
| April 28, 2015 | ANDA205064 | Aripiprazole ARIPIPRAZOLE | Hetero Labs Ltd V |
| August 15, 2014 | ANDA202862 | Olanzapine OLANZAPINE | Macleods Pharms Ltd |
| February 10, 2014 | ANDA202928 | Clopidogrel CLOPIDOGREL BISULFATE | Macleods Pharms |
| November 27, 2013 | ANDA202424 | Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | Aurolife Pharma LLC |
| September 16, 2013 | ANDA201537 | Azacitidine AZACITIDINE | DR Reddys |
| February 6, 2013 | ANDA202467 | Pioglitazone PIOGLITAZONE HYDROCHLORIDE | Macleods Pharms Ltd |
| February 4, 2013 | ANDA203263 | Doxorubicin hydrochloride DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) | Sun Pharm |
| October 3, 2012 | ANDA202254 | Irbesartan IRBESARTAN | Macleods Pharms Ltd |
| September 11, 2012 | ANDA202210 | Escitalopram ESCITALOPRAM OXALATE | Macleods Pharms Ltd |
| January 19, 2011 | ANDA077619 | Pantoprazole sodium PANTOPRAZOLE SODIUM | DR Reddys Labs Ltd |
| October 8, 2010 | ANDA090515 | Levetiracetam LEVETIRACETAM | Hetero Labs Ltd III |
| September 13, 2010 | ANDA079072 | Gemfibrozil GEMFIBROZIL | Northstar Hlthcare |
| April 14, 2010 | ANDA090048 | Memantine hydrochloride MEMANTINE HYDROCHLORIDE | DR Reddys Labs Ltd |
| September 28, 2009 | ANDA078771 | Timolol TIMOLOL MALEATE | Mankind Pharma |
| September 18, 2009 | ANDA078401 | Baclofen BACLOFEN | Northstar Hlthcare |
| March 31, 2008 | ANDA040840 | Hydroxyzine HYDROXYZINE HYDROCHLORIDE | Northstar Hlthcare |
| May 11, 2007 | ANDA077987 | Pravastatin sodium PRAVASTATIN SODIUM | Glenmark Pharms Ltd |
| August 22, 2000 | ANDA075459 | Enalapril maleate ENALAPRIL MALEATE | Sandoz Inc |
| August 22, 2000 | ANDA075496 | Enalapril maleate ENALAPRIL MALEATE | Sandoz Inc |
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
2026
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September 25, 2026 · Class III · Ongoing · D-0034-2027 · Tretinoin
Failed Impurities/Degradation Specifications
Tretinoin Cream USP, 0.05%, 45 g tube, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Product of Canada, NDC 16714-249-02.
2025
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October 22, 2025 · Class II · Ongoing · D-0152-2026 · Clomipramine hydrochloride
cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
clomiPRAMINE Hydrochloride, Capsules, USP, 25 mg, packaged in a) 30-count bottles (NDC 16714-849-01), b) 90-count bottles (NDC 16714-849-02), c) 100-count bottles (NDC 16714-849-03), Rx only, Manufactured for: Northstar
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October 22, 2025 · Class II · Ongoing · D-0153-2026 · Clomipramine hydrochloride
cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
clomiPRAMINE Hydrochloride, Capsules, USP, 50 mg, packaged in a) 30-count bottles (NDC 16714-850-01), b) 90-count bottles (NDC 16714-850-02), c) 100-count bottles (NDC 16714-850-03), Rx only, Manufactured for: Northstar
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October 22, 2025 · Class II · Ongoing · D-0154-2026 · Clomipramine hydrochloride
cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
clomiPRAMINE Hydrochloride, Capsules, USP, 75 mg, packaged in a) 30-count bottles (NDC 16714-851-01), b) 90-count bottles (NDC 16714-851-02), c) 100 capsules, NDC 16714-851-03 Rx only, Manufactured for: Northstar Rx LLC,
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September 3, 2025 · Class II · Ongoing · D-0633-2025 · Chlorpromazine hydrochloride
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Chlorpromazine Hydrochloride Tablets, USP, 25 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Manufactured for: Northstar Rx LLC Memphis, TN 38141. NDC: 16714-048-01
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September 3, 2025 · Class II · Ongoing · D-0631-2025 · Chlorpromazine hydrochloride
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Chlorpromazine Hydrochloride Tablets, USP, 10 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Manufactured for: Northstar Rx LLC Memphis, TN 38141. NDC: 16714-047-01
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September 3, 2025 · Class II · Ongoing · D-0635-2025 · Chlorpromazine hydrochloride
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Chlorpromazine Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Manufactured for: Northstar Rx LLC Memphis, TN 38141. NDC: 16714-049-01
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September 3, 2025 · Class II · Ongoing · D-0637-2025 · Chlorpromazine hydrochloride
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Chlorpromazine Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Manufactured for: Northstar Rx LLC Memphis, TN 38141. NDC: 16714-050-01
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September 3, 2025 · Class II · Ongoing · D-0639-2025 · Chlorpromazine hydrochloride
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Chlorpromazine Hydrochloride Tablets, USP, 200 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Manufactured for: Northstar Rx LLC Memphis, TN 38141. NDC: 16714-051-01
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March 13, 2025 · Class II · Ongoing · D-0351-2025 · Propafenone hydrochloride
CGMP Deviations
Propafenone Hydrochloride Extended-Release Capsules USP, 225mg 60-count bottles, Rx Only, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India. NDC# 16714-825-01.
Show the 15 older recalls
2025
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March 13, 2025 · Class II · Ongoing · D-0352-2025 · Propafenone hydrochloride
CGMP Deviations
Propafenone Hydrochloride Extended-Release Capsules, USP 325mg,60-count bottles, Rx Only, Mfd for: Northstar Rx LLC, Memphis, TN 38141, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India. N
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March 13, 2025 · Class II · Ongoing · D-0350-2025 · Pravastatin sodium
CGMP Deviations
Pravastatin Sodium Tablets, USP, 80mg, a).90-count bottle (16714-570-01), b). 500-count bottle (NDC 16714-570-02), Rx Only, Mfd for: Northstar Rx LLC, Memphis, TN 38141, Mfd by: Glenmark Pharmaceuticals Limited, Pithampu
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March 13, 2025 · Class II · Ongoing · D-0349-2025 · Pravastatin sodium
CGMP Deviations
Pravastatin Sodium Tablets, USP, 20mg, a).90-count bottle, Rx Only, Mfd for: Northstar Rx LLC, Memphis, TN 38141, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India. NDC# 16714-559-01
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January 29, 2025 · Class II · Ongoing · D-0240-2025 · Atomoxetine
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Atomoxetine Capsules, USP, 25 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-757-01.
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January 29, 2025 · Class II · Ongoing · D-0242-2025 · Atomoxetine
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Atomoxetine Capsules, USP, 60 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-759-01.
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January 29, 2025 · Class II · Ongoing · D-0239-2025 · Atomoxetine
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Atomoxetine Capsules, USP, 18 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-756-01.
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January 29, 2025 · Class II · Ongoing · D-0238-2025 · Atomoxetine
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Atomoxetine Capsules, USP, 10 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-755-01.
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January 29, 2025 · Class II · Ongoing · D-0241-2025 · Atomoxetine
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Atomoxetine Capsules, USP, 40 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-758-01.
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January 29, 2025 · Class II · Ongoing · D-0244-2025 · Atomoxetine
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-761-01.
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January 29, 2025 · Class II · Ongoing · D-0243-2025 · Atomoxetine
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-760-01.
2024
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March 4, 2024 · Class II · Ongoing · D-0369-2024 · Febuxostat
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Febuxostat Tablets 80mg, RX Only, 30 Tablets per bottle, NorthStarx, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Industries Limited Survey No. 259/15, Dadra-396 191, (U.T.
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March 4, 2024 · Class II · Ongoing · D-0368-2024 · Febuxostat
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Febuxostat Tablets 40mg, RX Only, 30 Tablets per bottle, NorthStarx, Manufactured for: Northstar Rx LLC., Memphis, TN 38141 , Manufactured by: Sun Pharmaceutical Industries Limited Survey No. 259/15, Dadra-396 191, (U.T.
2021
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October 25, 2021 · Class II · Terminated · D-0231-2022 · Tadalafil
Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product.
Tadalafil Tablets, USP 20 mg, 30 count bottle, Rx Only, Manufactured for: Northstar Rx LLC Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Industries Limited, India, NDC # 16714-077-01
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October 25, 2021 · Class II · Terminated · D-0230-2022 · Tadalafil
Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product.
Tadalafil Tablets, USP 5 mg, 30 count bottle, Rx Only, Manufactured for: Northstar Rx LLC Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Industries Limited, India, NDC # 16714-075-01
2014
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October 17, 2014 · Class II · Terminated · D-0330-2015 · Gabapentin
Failed Tablet/Capsule Specifications: Complaints of empty capsules received.
Gabapentin Capsules, USP 300 mg, 100-count bottles, Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141; Manufactured by: Aurobindo Pharma Limited, Unit-VII (SEZ), Mahaboob Nagar (Dt), AP-509302, INDIA, NDC 16
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).
Next steps
- Find a pharmacy near youAsk which company made your medicine and whether it is recalled
- Latest FDA drug recallsAll companies, newest first
- All drug companiesA to Z
- All prescription drugs A to ZSearch by generic, brand or Spanish name
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