Leading Pharma, LLC
NDC labeler code: 69315
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
- Doxepin hydrochlorideSilenor, Prudoxin, Zonalon · 6 products
- FenofibrateAntara, Lipofen, Tricor · 4 products
- Leucovorin calciumVykoura · 4 products
- FurosemideLasix, Furoscix, Lasix Onyu · 3 products
- HydrochlorothiazideInzirqo · 3 products
- Imipramine3 products
- Benztropine mesylate3 products
- AllopurinolAloprim · 3 products
- Clomipramine hydrochlorideAnafranil · 3 products
- LorazepamAtivan, Loreev XR · 3 products
- NystatinNystop, Klayesta, Nyamyc · 3 products
- Oxazepam3 products
- DiclofenacZipsor, Lofena, Cambia · 2 products
- ProchlorperazineCompro · 2 products
- OfloxacinOcuflox · 2 products
- Varenicline tartrateChantix, Tyrvaya · 2 products
- GlycopyrrolateGlyrx-Pf, Glycate, Cuvposa · 2 products
- EtravirineIntelence · 2 products
- TheophyllineTheo-24 · 2 products
- Fenofibric acid2 products
- Ketorolac tromethamineAcuvail, Sprix, Ketrolac Tromethamine · 2 products
- PhenylephrineBiorphen, Immphentiv · 2 products
- CiprofloxacinCiprofloxacin in Dextrose, Cipro, Ciloxan · 1 product
- HydrocortisoneSolu-Cortef, Proctozone-Hc, Alkindi Sprinkle · 1 product
- DifluprednateDifluprednate Ophthalmic Emulsion, Durezol · 1 product
- Folic acidQuiofic · 1 product
- Carbinoxamine maleateKarbinal ER, Carbzah, Ryvent · 1 product
- Dorzolamide hydrochloride1 product
- GatifloxacinZymaxid · 1 product
- OxybutyninOxytrol · 1 product
- TimololTimoptic in Ocudose, Timoptic-Xe, Timoptic · 1 product
- HydroxyureaDroxia, Hydrea, Siklos · 1 product
- Brimonidine tartrate and timolol maleateCombigan · 1 product
- Ethacrynate sodium1 product
- Frovatriptan succinate1 product
- Oseltamivir phosphateTamiflu · 1 product
- Dorzolamide hydrochloride and timolol maleateCosopt, Dorzolamide Hydrochloride Timolol Maletae, Cosopt Pf · 1 product
- Diphenoxylate hydrochloride and atropine sulfateLomotil · 1 product
- LacosamideVimpat, Motpoly XR · 1 product
- Metformin hydrochlorideGlumetza · 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 |
|---|---|---|---|
| April 16, 2025 | ANDA216998 | Frovatriptan succinate FROVATRIPTAN SUCCINATE | Leading |
| March 3, 2025 | ANDA218261 | Oxazepam OXAZEPAM | Leading |
| February 25, 2025 | ANDA219093 | Brimonidine tartrate and timolol maleate BRIMONIDINE TARTRATE AND TIMOLOL MALEATE | Caplin |
| December 19, 2024 | ANDA215476 | Carbinoxamine maleate CARBINOXAMINE MALEATE | Leading |
| December 13, 2024 | ANDA219441 | Difluprednate DIFLUPREDNATE | Caplin |
| September 30, 2024 | ANDA218912 | Prochlorperazine PROCHLORPERAZINE MALEATE | Leading |
| August 7, 2024 | ANDA218460 | Timolol TIMOLOL MALEATE | Caplin |
| May 23, 2024 | ANDA215183 | Phenylephrine PHENYLEPHRINE HYDROCHLORIDE | Caplin |
| April 12, 2024 | ANDA217904 | Ofloxacin OFLOXACIN | Caplin |
| March 26, 2024 | ANDA218204 | Ketorolac tromethamine KETOROLAC TROMETHAMINE | Caplin |
| January 5, 2024 | ANDA217903 | Ofloxacin OFLOXACIN | Caplin |
| July 25, 2023 | ANDA217151 | Varenicline tartrate VARENICLINE TARTRATE | Pharmazone |
| February 23, 2023 | ANDA215745 | Ketorolac tromethamine KETOROLAC TROMETHAMINE | Leading |
| February 6, 2023 | ANDA216461 | Lacosamide LACOSAMIDE | Pharmazone |
| January 30, 2023 | ANDA214950 | Theophylline THEOPHYLLINE | Velzen Pharma Pvt |
| April 13, 2022 | ANDA215402 | Etravirine ETRAVIRINE | Pharmobedient |
| March 10, 2022 | ANDA214346 | Nystatin NYSTATIN | Pharmazone |
| March 7, 2022 | ANDA214443 | Allopurinol ALLOPURINOL | Harman Finochem |
| February 28, 2022 | ANDA214949 | Oseltamivir phosphate OSELTAMIVIR PHOSPHATE | Leading |
| November 3, 2021 | ANDA213542 | Gatifloxacin GATIFLOXACIN | Caplin |
| March 9, 2021 | ANDA211619 | Doxepin hydrochloride DOXEPIN HYDROCHLORIDE | Leading |
| March 1, 2021 | ANDA211618 | Doxepin hydrochloride DOXEPIN HYDROCHLORIDE | Velzen Pharma Pvt |
| October 22, 2020 | ANDA213929 | Leucovorin calcium LEUCOVORIN CALCIUM | Leading |
| June 9, 2020 | ANDA208663 | Ethacrynate sodium ETHACRYNATE SODIUM | Sterimax |
| April 8, 2020 | ANDA213438 | Hydroxyurea HYDROXYUREA | Leading |
Show the other 22 applications
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| April 6, 2020 | ANDA212798 | Oxybutynin OXYBUTYNIN CHLORIDE | Leading |
| March 18, 2020 | ANDA211122 | Fenofibrate FENOFIBRATE | Rising |
| February 20, 2020 | ANDA213413 | Diphenoxylate hydrochloride and atropine sulfate DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | Leading |
| February 7, 2020 | ANDA211364 | Clomipramine hydrochloride CLOMIPRAMINE HYDROCHLORIDE | Leading |
| July 18, 2019 | ANDA211626 | Fenofibric acid FENOFIBRIC ACID | Rising |
| June 13, 2019 | ANDA205295 | Dorzolamide hydrochloride and timolol maleate DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE | Fdc Ltd |
| January 24, 2019 | ANDA205294 | Dorzolamide hydrochloride DORZOLAMIDE HYDROCHLORIDE | Fdc Ltd |
| August 17, 2018 | ANDA210606 | Fenofibrate FENOFIBRATE | Rising |
| May 21, 2018 | ANDA209082 | Nystatin NYSTATIN | Lyne |
| May 30, 2017 | ANDA208838 | Nystatin NYSTATIN | Lyne |
| November 28, 2012 | ANDA090168 | Benztropine mesylate BENZTROPINE MESYLATE | Leading |
| October 24, 2012 | ANDA040903 | Imipramine IMIPRAMINE HYDROCHLORIDE | Leading |
| September 21, 2012 | ANDA090195 | Glycopyrrolate GLYCOPYRROLATE | Velzen Pharma Pvt |
| January 18, 2012 | ANDA201991 | Metformin hydrochloride METFORMIN HYDROCHLORIDE | Adaptis |
| June 17, 2009 | NDA022165 | Diclofenac CAMBIA | Cosette |
| June 16, 2009 | NDA022202 | Diclofenac ZIPSOR | Cosette |
| January 12, 2009 | ANDA040796 | Folic acid FOLIC ACID | Leading |
| June 30, 2008 | ANDA077568 | Ciprofloxacin CIPROFLOXACIN HYDROCHLORIDE | Fdc Ltd |
| July 30, 2007 | ANDA078203 | Lorazepam LORAZEPAM | Leading |
| March 16, 2007 | ANDA040702 | Hydrochlorothiazide HYDROCHLOROTHIAZIDE | Leading |
| November 9, 2005 | ANDA077293 | Furosemide FUROSEMIDE | Leading |
| April 21, 1983 | ANDA085025 | Hydrocortisone HYDROCORTISONE | Padagis Us |
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
2026
-
March 20, 2026 · Class II · Ongoing · D-0486-2026 · Furosemide
CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.
Furosemide Tablets, USP, 80 mg, 100 Tablets bottles, Rx only, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004, NDC 69315-118-01
2025
-
March 11, 2025 · Class II · Ongoing · D-0282-2025 · Ciprofloxacin
Defective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, package in 5 mL bottles, Rx Only, Distributed by: Leading Pharma LLC, Fairfield, NJ. Manufactured by: FDC Limited, Maharashtra, India, NDC 69315-308-05
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January 21, 2025 · Class II · Ongoing · D-0227-2025 · Lorazepam
Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
Lorazepam Tablets, USP, 1mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this package is from NDC # 69315-905 Leading Pharma, LLC., Packaged and Distributed by: Major
-
January 21, 2025 · Class II · Ongoing · D-0228-2025 · Lorazepam
Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
Lorazepam Tablets, USP, 2mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this package is from NDC # 69315-906 Leading Pharma, LLC., Packaged and Distributed by: Major
-
January 21, 2025 · Class II · Ongoing · D-0226-2025 · Lorazepam
Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
Lorazepam Tablets, USP, 0.5mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this package is from NDC # 69315-904 Leading Pharma, LLC., Packaged and Distributed by: Maj
2024
-
December 16, 2024 · Class II · Ongoing · D-0182-2025 · Ciprofloxacin
Defective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, Sterile, package in 5 mL bottles, Rx Only, Distributed by: Leading Pharma LLC, Fairfield, NJ. Manufactured by: FDC Limited, Maharashtra, India, NDC 69315-308-05
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July 23, 2024 · Class II · Ongoing · D-0623-2024 · Ciprofloxacin
Defective container: unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
Ciprofloxacin ophthalmic solution USP, 0.3% as base, package in bottles: a) 10 mL (NDC 69315-308-10), b) 2.5 mL (NDC 69315-308-02), Rx Only, Distributed by: Leading Pharma LLC, Fairfield, NJ. Manufactured by: FDC Limited
2022
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August 23, 2022 · Class III · Terminated · D-1546-2022 · Clomipramine hydrochloride
Superpotent Drug: Assay value found to be 110.6% in Chlomipramine Hydrocholoride capsules
ClomiPRAMINE Hydrochloride Capsules, USP 25mg, 100-count bottles, Rx only, LEADING PHARMA, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004, NDC 69315-167-01
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January 26, 2022 · Class II · Terminated · D-0183-2024 · Folic acid
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
FOLIC ACID TABLETS, USP, 1MG, 100 Tablets per bottle, Rx Only, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004. NDC: 69315-127-10
2017
-
September 28, 2017 · Class II · Terminated · D-0085-2018 · Lorazepam
Labeling: Label Error on Declared Strength. Bottle labeled as 0.5 mg tablets contained 1mg tablets of lorazepam
Lorazepam Tablets, USP CIV, 0.5 mg, 500-count bottle, Rx Only, Manufactured by: Leading Pharma, LLC Fairfield, NJ 07004 NDC 69315-904-05
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
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- 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