Novartis Pharmaceuticals recalls

Novartis Pharmaceuticals has 33 recalls on record with the FDA and USDA, the earliest in 2013 and the latest reported on 19 Aug 2026. 3 are still ongoing. 1 was reported in the last 12 months.

Total recalls33since 2013
Last 12 months1reported
Class I39% of total
Ongoing3latest 19 Aug 2026

Recalls per month, last 24 months

click a bar for that month

Severity split

Class I 3 9%Class II 17 52%Class III 13 39%

Why novartis pharmaceuticals is recalled

By year

Ongoing novartis pharmaceuticals recalls

3 active

All novartis pharmaceuticals recalls, newest first

33 total
ReportedClassRecallCompanyReasonWhere
DrugCLASS IIDiovan (valsartan) 160 mg recalled by Novartis PharmaceuticalsDiovanNovartis PharmaceuticalsPotency & AssayNationwide
DrugCLASS ISandimmune Oral Solution (cyclosporine oral solution, USP) 100 mg/mL recalledNovartis PharmaceuticalsOtherNationwide
DrugCLASS ISandimmune Oral Solution (cyclosporine oral solution, USP) 100 mg/mL recalledNovartis PharmaceuticalsOtherNationwide
DrugCLASS IINeoral soft gelatin capsules (cyclosporine capsules recalledNeoralNovartis PharmaceuticalsPotency & AssayNationwide
DrugCLASS IIIXiidra (lifitegrast ophthalmic solution) recalledXiidraNovartis PharmaceuticalsPotency & AssayNationwide
DrugCLASS IIIXiidra (lifitegrast ophthalmic solution) recalledNovartis PharmaceuticalsPotency & AssayNationwide
DrugCLASS IIIXiidra (lifitegrast ophthalmic solution) 5% Professional Sample recalledXiidraNovartis PharmaceuticalsPotency & AssayNationwide
DrugCLASS IIIXiidra (lifitegrast ophthalmic solution) 5% Professional Sample recalledNovartis PharmaceuticalsPotency & AssayNationwide
DrugCLASS IPromacta (eltrombopag) 12.5 mg for Oral Suspension recalledPromactaNovartis PharmaceuticalsOtherNationwide
DrugCLASS IIIPilocarpine Hydrochloride Ophthalmic Solution recalledPilocarpine HydrochlorideNovartis PharmaceuticalsPotency & AssayNationwide
DrugCLASS IIIIsopto Carpine (pilocarpine hydrochloride opthalmic solution) recalledNovartis PharmaceuticalsPotency & AssayNationwide
DrugCLASS IIIDexmethylphenidate HCl Extended-Release, Capsules, 10mg recalledNovartis PharmaceuticalsPotency & AssayNJ
DrugCLASS IIIForadil Aerolizer (formoterol fumarate inhalation powder) recalledNovartis PharmaceuticalsPotency & AssayNJ
DrugCLASS IIIForadil Aerolizer (formoterol fumarate inhalation powder) recalledNovartis PharmaceuticalsPotency & AssayNJ
DrugCLASS IIICataflam (diclofenac potassium) tablets, 50 mg recalledNovartis PharmaceuticalsOtherNationwide
DrugCLASS IIIForadil Aerolizer (formoterol fumarate inhalation powder) recalledNovartis PharmaceuticalsPotency & AssayNationwide
DrugCLASS IIIRitalin HCl (methylphenidate HCl) USP, 20 mg recalledNovartis PharmaceuticalsPackaging DefectsNationwide
DrugCLASS IIIRitalin HCl (methylphenidate HCl) USP, 10 mg recalledNovartis PharmaceuticalsPackaging DefectsNationwide
DrugCLASS IITekturna (aliskiren) Tablets 300 mg recalled by Novartis PharmaceuticalsNovartis PharmaceuticalsOtherNationwide
DrugCLASS IIExforge (amlodipine and valsartan Tablets) 5/320 mg recalledNovartis PharmaceuticalsOtherNationwide
DrugCLASS IITekturna HCT (aliskiren and hydrochlorothiazide) Tablets recalledNovartis PharmaceuticalsOtherNationwide
DrugCLASS IIDiovan (valsartan) recalled by Novartis PharmaceuticalsNovartis PharmaceuticalsOtherNationwide
DrugCLASS IILescol XL (fluvastatin sodium) Extended-Release Tablets recalledNovartis PharmaceuticalsOtherNationwide
DrugCLASS IITekturna HCT (aliskiren and hydrochlorothiazide) Tablets recalledNovartis PharmaceuticalsOtherNationwide
DrugCLASS IIDiovan (valsartan) recalled by Novartis PharmaceuticalsNovartis PharmaceuticalsOtherNationwide
DrugCLASS IIExforge HCT (amlodipine, valsartan recalled by Novartis PharmaceuticalsNovartis PharmaceuticalsOtherNationwide
DrugCLASS IIExforge (amlodipine and valsartan, Tablets) 10/320 mg recalledNovartis PharmaceuticalsOtherNationwide
DrugCLASS IIExforge HCT (amlodipine, valsartan recalled by Novartis PharmaceuticalsNovartis PharmaceuticalsOtherNationwide
DrugCLASS IIExforge (amlodipine and valsartan Tablets) 10/160 mg recalledNovartis PharmaceuticalsOtherNationwide
DrugCLASS IIExforge (amlodipine and valsartan Tablets) 5/160 mg recalledNovartis PharmaceuticalsOtherNationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.