Novartis Pharmaceuticals recalls
FDA enforcement reports naming Novartis Pharmaceuticals Corp. as the recalling firm.
- Recall reports
- 33
- Class I (serious)
- 3
- Most recent report
- Aug 19, 2026
- Aug 19, 2026Diovan (valsartan) 160 mg, 90 tablets, Rx only, Manufactured by: Patheon Manufacturing…Drug · Novartis Pharmaceuticals CorporationFailed Dissolution SpecificationsClass II
- Dec 13, 2023SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL bottle, Rx…Drug · Novartis Pharmaceuticals CorporationCrystallization: bottles of Sandimmune Oral Solution were determined to contain crystalsClass I
- Sep 27, 2023SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL bottle, Rx…Drug · Novartis Pharmaceuticals Corp.Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals.Class I
- Oct 5, 2022Neoral soft gelatin capsules (cyclosporine capsules, USP) Modified, 25 mg, Rx Only, 30…Drug · Novartis Pharmaceuticals CorporationCGMP deviations: Out of specification results obtained during routine stability testing for ethanol content.Class II
- Jun 15, 2022Xiidra (lifitegrast ophthalmic solution) 5% PROFESSIONAL SAMPLE, packaged in a) 5 singl…Drug · Novartis Pharmaceuticals CorporationFailed Impurities/Degradation Specifications.Class III
- Jun 15, 2022Xiidra (lifitegrast ophthalmic solution) 5% PROFESSIONAL SAMPLE, packaged in a) 5 singl…Drug · Novartis Pharmaceuticals CorporationFailed Impurities/Degradation Specifications.Class III
- Jun 15, 2022Xiidra (lifitegrast ophthalmic solution) 5%, packaged in a) 60 Single-Use Containers: 1…Drug · Novartis Pharmaceuticals CorporationFailed Impurities/Degradation Specifications.Class III
- Jun 15, 2022Xiidra (lifitegrast ophthalmic solution), packaged in a) 60 Single-Use Containers: 12 p…Drug · Novartis Pharmaceuticals CorporationFailed Impurities/Degradation Specifications.Class III
- May 29, 2019Promacta (eltrombopag) 12Drug · Novartis Pharmaceuticals Corp.Cross Contamination with Other Products: product is being recalled due to possible cross-contamination with peanut flour.Class I
- May 3, 2017Pilocarpine Hydrochloride Ophthalmic Solution 4% , packaged in 15 mL bottles, Rx Only,…Drug · Novartis Pharmaceuticals Corp.Failed Impurities/Degradation Specifications.Class III
- Isopto Carpine (pilocarpine hydrochloride opthalmic solution) 4%, packaged in 15 mL bot…
- Dexmethylphenidate HCl Extended-Release, Capsules, 10mg, Rx only, 100 Capsules
- Foradil Aerolizer (formoterol fumarate inhalation powder) 12 mcg per capsule, 12 Capsu…
- Foradil Aerolizer (formoterol fumarate inhalation powder) 12 mcg per capsule, 60 Capsu…
- Cataflam (diclofenac potassium) tablets, 50 mg, 100-count bottles, Rx only, Manufacture…
- Foradil Aerolizer (formoterol fumarate inhalation powder), 12 mcg per capsule, 60 Capsu…
- Ritalin HCl (methylphenidate HCl) USP, 10 mg, 100 tablets per Bottle, Rx only, Mfd
- Ritalin HCl (methylphenidate HCl) USP, 20 mg, 100 tablets per Bottle, Rx only, Mfd
- Exforge (amlodipine and valsartan, Tablets) 10/320 mg, Rx only, 7 tablets per bottle, P…
- Exforge (amlodipine and valsartan Tablets) 10/160 mg, Rx only, 7 tablets per bottle, Ph…
- Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) 5/160/25 mg, Rx only, 7 tablet…
- Diovan (valsartan) 160 mg per tablet, 7 Tablets per bottle, Rx only Physician Sample N…
- Diovan (valsartan) 320 mg per tablet, 7 Tablets per bottle, Rx only Physician Sample N…
- Exforge (amlodipine and valsartan Tablets) 5/160 mg, Rx only 7 tablets per bottle, Phys…
- Exforge (amlodipine and valsartan Tablets) 5/320 mg, Rx only 7 tablets per bottle, Phys…
- Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) 10/320/25 mg, Rx only, 7 table…
- Tekturna HCT (aliskiren and hydrochlorothiazide) Tablets 300/25 mg, 7 tablets per bottl…
- Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) 5/160/12
- Tekturna HCT (aliskiren and hydrochlorothiazide) Tablets 150/12
- Tekturna (aliskiren) Tablets 300 mg, 7 tablets per bottle, Physician Sample-Not For Sal…
- Tekturna (aliskiren) Tablets 150 mg, 7 tablets per bottle, Physician Sample-Not For Sal…
- Stalevo (carbidopa, levodopa, and entacapone) 12
- Lescol XL (fluvastatin sodium) Extended-Release Tablets, 80 mg per tablet, 7 tablets pe…
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