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Novartis Pharmaceuticals Recalls
33 recalls on record · December 18, 2013 to August 19, 2026 · Drugs
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
August 19, 2026DrugsFDA
Novartis Pharmaceuticals Corporation recalls Diovan (valsartan) 160 mg, 90 tablets, Rx only, Manufactured by: Patheon Manufacturing Services LLC, Greenville, NC 2783
Hazard: Failed Dissolution Specifications
December 13, 2023DrugsFDA
Novartis Pharmaceuticals Corporation recalls SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL bottle, Rx Only, Manufactured by: DELPHARM H
Hazard: Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals
September 27, 2023DrugsFDA
Novartis Pharmaceuticals Corp. recalls SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL bottle, Rx Only, Manufactured by: DELPHARM
Hazard: Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals.
October 5, 2022DrugsFDA
Novartis Pharmaceuticals Corporation recalls Neoral soft gelatin capsules (cyclosporine capsules, USP) Modified, 25 mg, Rx Only, 30 Soft Gelatin Capsules per carton,
Hazard: CGMP deviations: Out of specification results obtained during routine stability testing for ethanol content.
June 15, 2022DrugsFDA
Novartis Pharmaceuticals Corporation recalls Xiidra (lifitegrast ophthalmic solution) 5% PROFESSIONAL SAMPLE, packaged in a) 5 single-use containers (0.2 mL each via
Hazard: Failed Impurities/Degradation Specifications.
June 15, 2022DrugsFDA
Novartis Pharmaceuticals Corporation recalls Xiidra (lifitegrast ophthalmic solution) 5% PROFESSIONAL SAMPLE, packaged in a) 5 single-use containers (0.2 mL each via
Hazard: Failed Impurities/Degradation Specifications.
June 15, 2022DrugsFDA
Novartis Pharmaceuticals Corporation recalls Xiidra (lifitegrast ophthalmic solution) 5%, packaged in a) 60 Single-Use Containers: 12 pouches x 5 single-use containe
Hazard: Failed Impurities/Degradation Specifications.
June 15, 2022DrugsFDA
Novartis Pharmaceuticals Corporation recalls Xiidra (lifitegrast ophthalmic solution), packaged in a) 60 Single-Use Containers: 12 pouches x 5 single-use containers
Hazard: Failed Impurities/Degradation Specifications.
May 29, 2019DrugsFDA
Novartis Pharmaceuticals Corp. recalls Promacta (eltrombopag) 12.5 mg for Oral Suspension, Rx Only Manufactured by: Halo Pharmaceuticals, Inc. Whippany, New J
Hazard: Cross Contamination with Other Products: product is being recalled due to possible cross-contamination with peanut flour.
May 3, 2017DrugsFDA
Novartis Pharmaceuticals Corp. recalls Pilocarpine Hydrochloride Ophthalmic Solution 4% , packaged in 15 mL bottles, Rx Only, Manufactured by Alcon Laboratorie
Hazard: Failed Impurities/Degradation Specifications.
May 3, 2017DrugsFDA
Novartis Pharmaceuticals Corp. recalls Isopto Carpine (pilocarpine hydrochloride opthalmic solution) 4%, packaged in 15 mL bottle, Rx only, Manufactured by: A
Hazard: Failed Impurities/Degradation Specifications.
September 23, 2015DrugsFDA
Novartis Pharmaceuticals Corp. recalls Dexmethylphenidate HCl Extended-Release, Capsules, 10mg, Rx only, 100 Capsules. Manufactured by Alkermes Gainesville LL
Hazard: Failed Dissolution Specifications: Product is being recalled due to out of specification (above specification) result obtained at 6-hour dissolution time point during the 12-month stability testing.
June 24, 2015DrugsFDA
Novartis Pharmaceuticals Corp. recalls Foradil Aerolizer (formoterol fumarate inhalation powder) 12 mcg per capsule, 60 Capsules (Blister strips of 6) per pac
Hazard: Failed Stability Specification: out of specification result obtained for the Particle Size Distribution test during stability testing.
June 24, 2015DrugsFDA
Novartis Pharmaceuticals Corp. recalls Foradil Aerolizer (formoterol fumarate inhalation powder) 12 mcg per capsule, 12 Capsules (Blister strips of 6) per pac
Hazard: Failed Stability Specification: out of specification result obtained for the Particle Size Distribution test during stability testing.
August 13, 2014DrugsFDA
Novartis Pharmaceuticals Corp. recalls Cataflam (diclofenac potassium) tablets, 50 mg, 100-count bottles, Rx only, Manufactured by: Patheon Inc., Whitby Operat
Hazard: Failed Tablet/Capsule Specifications: Ink identification had rubbed off tablets in transit making them illegible to pharmacists and consumers.
June 25, 2014DrugsFDA
Novartis Pharmaceuticals Corp. recalls Foradil Aerolizer (formoterol fumarate inhalation powder), 12 mcg per capsule, 60 Capsules, Rx only, Manufactured for: M
Hazard: Failed Stability Specification; out of specification result for particle size distribution during stability testing
April 16, 2014DrugsFDA
Novartis Pharmaceuticals Corp. recalls Ritalin HCl (methylphenidate HCl) USP, 20 mg, 100 tablets per Bottle, Rx only, Mfd. by: Novartis Pharmaceuticals Corp. S
Hazard: Labeling: Incorrect or Missing Package Insert; The back of the Medication Guide attached to the Package Insert for Ritalin Tablets was printed with information related to Ritalin SR (Sustained Release) Tablets. Both products, Ritalin Tablets and Ritalin SR Tablets utilize a combined Package Insert. The individual Medication Guides are attached to the Package Insert via a perforation. Although t
April 16, 2014DrugsFDA
Novartis Pharmaceuticals Corp. recalls Ritalin HCl (methylphenidate HCl) USP, 10 mg, 100 tablets per Bottle, Rx only, Mfd. by: Novartis Pharmaceuticals Corp. S
Hazard: Labeling: Incorrect or Missing Package Insert; The back of the Medication Guide attached to the Package Insert for Ritalin Tablets was printed with information related to Ritalin SR (Sustained Release) Tablets. Both products, Ritalin Tablets and Ritalin SR Tablets utilize a combined Package Insert. The individual Medication Guides are attached to the Package Insert via a perforation. Although t
December 18, 2013DrugsFDA
Novartis Pharmaceuticals Corp. recalls Tekturna HCT (aliskiren and hydrochlorothiazide) Tablets 300/25 mg, 7 tablets per bottle, Physician Sample-Not For Sale,
Hazard: Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photo curing agent used in inks on shrink-wrap sleeves.
December 18, 2013DrugsFDA
Novartis Pharmaceuticals Corp. recalls Tekturna HCT (aliskiren and hydrochlorothiazide) Tablets 150/12.5 mg, 7 tablets per bottle, Physician Sample-Not For Sal
Hazard: Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photo curing agent used in inks on shrink-wrap sleeves.
December 18, 2013DrugsFDA
Novartis Pharmaceuticals Corp. recalls Tekturna (aliskiren) Tablets 300 mg, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only. Manufactured by: Nov
Hazard: Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photocuring agent used in inks on shrink-wrap sleeves.
December 18, 2013DrugsFDA
Novartis Pharmaceuticals Corp. recalls Tekturna (aliskiren) Tablets 150 mg, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only. Manufactured by: Nov
Hazard: Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photocuring agent used in inks on shrink-wrap sleeves.
December 18, 2013DrugsFDA
Novartis Pharmaceuticals Corp. recalls Stalevo (carbidopa, levodopa, and entacapone) 12.5/50/200 mg, 7 tablets per bottle, Physician Sample-Not For Sale, Rx on
Hazard: Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photocuring agent used in inks on shrink-wrap sleeves.
December 18, 2013DrugsFDA
Novartis Pharmaceuticals Corp. recalls Lescol XL (fluvastatin sodium) Extended-Release Tablets, 80 mg per tablet, 7 tablets per bottle, Physician Sample-Not Fo
Hazard: Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photocuring agent used in inks on shrink-wrap sleeves.
December 18, 2013DrugsFDA
Novartis Pharmaceuticals Corp. recalls Exforge (amlodipine and valsartan, Tablets) 10/320 mg, Rx only, 7 tablets per bottle, Physician Sample - Not For Sale. M
Hazard: Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photocuring agent used in inks on shrink-wrap sleeves.
December 18, 2013DrugsFDA
Novartis Pharmaceuticals Corp. recalls Exforge (amlodipine and valsartan Tablets) 10/160 mg, Rx only, 7 tablets per bottle, Physician Sample - Not For Sale. Ma
Hazard: Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photocuring agent used in inks on shrink-wrap sleeves.
December 18, 2013DrugsFDA
Novartis Pharmaceuticals Corp. recalls Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) 5/160/25 mg, Rx only, 7 tablets per bottle, Physician Sample -
Hazard: Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photocuring agent used in inks on shrink-wrap sleeves.
December 18, 2013DrugsFDA
Novartis Pharmaceuticals Corp. recalls Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) 5/160/12.5 mg, Rx only, 7 tablets per bottle, Physician Sample
Hazard: Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photocuring agent used in inks on shrink-wrap sleeves.
December 18, 2013DrugsFDA
Novartis Pharmaceuticals Corp. recalls Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) 10/320/25 mg, Rx only, 7 tablets per bottle, Physician Sample -
Hazard: Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photocuring agent used in inks on shrink-wrap sleeves.
December 18, 2013DrugsFDA
Novartis Pharmaceuticals Corp. recalls Exforge (amlodipine and valsartan Tablets) 5/320 mg, Rx only 7 tablets per bottle, Physician Sample - Not For Sale. Man
Hazard: Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photocuring agent used in inks on shrink-wrap sleeves.