Novartis Pharmaceuticals Corporation
NDC labeler code: 0078
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
- EverolimusYulithira, Zortress, Afinitor · 11 products
- DeferasiroxJadenu, Deferasorox, Exjade · 9 products
- Dexmethylphenidate hydrochlorideFocalin XR, Focalin · 8 products
- ValsartanDiovan · 7 products
- Sacubitril and valsartanEntresto · 7 products
- CyclosporineSandimmune, Neoral, Cyclosporine Modified · 6 products
- EltrombopagPromacta · 6 products
- CarbamazepineTegretol XR, Equetro, Carbatrol · 5 products
- Amlodipine besylate valsartan hydrochlorothiazideExforge Hct · 5 products
- AlpelisibVijoice, Piqray · 5 products
- Valsartan and hydrochlorothiazideDiovan Hct · 5 products
- MethylphenidateMetadate Cd, Relexxii, Methylphenidate Hydrochloride Cd · 4 products
- Amlodipine and valsartanExforge · 4 products
- OxcarbazepineTrileptal, Oxtellar XR · 4 products
- SecukinumabCosentyx · 4 products
- Imatinib mesylateGleevec, Imkeldi · 3 products
- DabrafenibTafinlar · 3 products
- Octreotide acetateSandostatin, Bynfezia Pen · 3 products
- RivastigmineRivastigmine Transdermal System, Exelon · 3 products
- NilotinibTasigna, Danziten, Cavhanza · 3 products
- AsciminibScemblix · 3 products
- SiponimodMayzent · 3 products
- RibociclibKisqali · 3 products
- TrametinibMekinist · 3 products
- CapmatinibTabrecta · 2 products
- Mycophenolic acidMyfortic · 2 products
- BasiliximabSimulect · 2 products
- FingolimodGilenya · 2 products
- Betaxolol hydrochlorideBetoptic S · 1 product
- IptacopanFabhalta · 1 product
- Deferoxamine mesylateDesferal · 1 product
- LetrozoleFemara · 1 product
- CanakinumabIlaris · 1 product
- Tobramycin and dexamethasoneTobradex St, Tobradex · 1 product
- Travoprost ophthalmic solutionTravatan Z, Idose Tr, Travoprost Ophthalmic Soluton · 1 product
- LapatinibTykerb · 1 product
- Triamcinolone acetonideKenalog-40, Triderm, Triesence · 1 product
- Lutetium lu 177 vipivotide tetraxetanPluvicto · 1 product
- PazopanibVotrient · 1 product
- TriclabendazoleEgaten · 1 product
- InclisiranLeqvio · 1 product
- TopotecanHycamtin · 1 product
- Rydapt1 product
- CrizanlizumabAdakveo · 1 product
- LifitegrastXiidra · 1 product
- AtrasentanVanrafia · 1 product
- RemibrutinibRhapsido · 1 product
- Artemether and lumefantrineCoartem · 1 product
- CeritinibZykadia · 1 product
- Neomycin sulfate, polymyxin b sulfate and dexamethasoneNeomycin and Polymyxin B Sulfates and Dexamethasone, Neomycin Polymyxin B Sulfates and Dexamethasone, Maxitrol · 1 product
- TobramycinTobramycin Inhalation Solution Pak, Tobi, Tobi Podhaler · 1 product
- BrolucizumabBeovu · 1 product
- ClofazimineLamprene · 1 product
- Kit for the preparation of gallium ga 68 gozetotideLocametz · 1 product
- NepafenacIlevro, Nevanac · 1 product
- OfatumumabKesimpta · 1 product
FDA applications for these products
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
2026
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August 4, 2026 · Class II · Ongoing · D-0746-2026 · Valsartan
Failed Dissolution Specifications
Diovan (valsartan) 160 mg, 90 tablets, Rx only, Manufactured by: Patheon Manufacturing Services LLC, Greenville, NC 27834, Distributed by: Novartis Pharmaceutical Corp, East Hanover, NJ 07936, NDC 0078-0359-34
2023
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November 20, 2023 · Class III · Completed · D-0149-2024 · Pazopanib
Failed Dissolution Specifications
Votrient (pazopanib) 200 mg tablets, 120-count bottle, Rx Only, Manufactured by: Siegried Barbera, S.L., Barbera del Valles, Spain, Distributed by: Novartis Pharmaceuticals Corp., East Hanover, N.J. 07936, NDC 0078-1077-
2022
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September 16, 2022 · Class II · Terminated · D-1543-2022 · Cyclosporine
CGMP deviations: Out of specification results obtained during routine stability testing for ethanol content.
Neoral soft gelatin capsules (cyclosporine capsules, USP) Modified, 25 mg, Rx Only, 30 Soft Gelatin Capsules per carton, Mfg by: Novartis Pharmaceuticals Corporation, East Hanover, NJ 07936, NDC # 0078-0246-15.
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May 10, 2022 · Class III · Terminated · D-0982-2022 · Lifitegrast
Failed Impurities/Degradation Specifications.
Xiidra (lifitegrast ophthalmic solution), packaged in a) 60 Single-Use Containers: 12 pouches x 5 single-use containers (0.2 mL each vial) (NDC 0078-0911-12) and b) 5- Single-Use Containers (NDC 0078-0911-05) Rx Only, Ma
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May 10, 2022 · Class III · Terminated · D-0984-2022 · Lifitegrast
Failed Impurities/Degradation Specifications.
Xiidra (lifitegrast ophthalmic solution) 5% PROFESSIONAL SAMPLE, packaged in a) 5 single-use containers (0.2 mL each vial) (NDC 0078-0911-95) and b) 4 pouches x 5 single-use containers (NDC 0078-0911-94), Rx Only, Manufa
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April 13, 2022 · Class II · Terminated · D-0995-2022 · Tobramycin and dexamethasone
cGMP deviations: Temperature abuse
TobraDex (tobramycin and dexamethasone), Ophthalmic Ointment, 3.5 gm, Rx only, Manufacturer: Novartis, NDC 0078-0876-01
2019
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May 11, 2019 · Class I · Terminated · D-1309-2019 · Eltrombopag
Cross Contamination with Other Products: product is being recalled due to possible cross-contamination with peanut flour.
Promacta (eltrombopag) 12.5 mg for Oral Suspension, Rx Only Manufactured by: Halo Pharmaceuticals, Inc. Whippany, New Jersey 07981 Distributed by: Novartis Pharmaceuticals Corporation East Hanover, NJ 07936 Product of Ir
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