Novartis Pharmaceuticals Corporation Recalls

All product recalls associated with Novartis Pharmaceuticals Corporation.

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Recall Summary

Total Recalls

32

Past Year

0

Class I (Serious)

3

Most Recent

Nov 2023

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–20 of 32 recalls

SANDIMMUNE Oral Solution (Novartis) – Crystallization Risk (2023)

Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals

Class IHigh

FDANov 22, 2023Nationwide• Novartis Pharmaceuticals Corporation

Sandimmune Oral Solution (Novartis) – Crystallization Issue (2023)

Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals.

Class IHigh

FDASep 8, 2023Nationwide• Novartis Pharmaceuticals Corp.

Neoral Cyclosporine Capsules (Novartis) – Ethanol Content Issue (2022)

CGMP deviations: Out of specification results obtained during routine stability testing for ethanol content.

Class II

Moderate

FDASep 16, 2022Nationwide• Novartis Pharmaceuticals Corporation

Xiidra (Novartis) - Impurity Specifications (2022)

Failed Impurities/Degradation Specifications.

Class IIILow

FDAMay 10, 2022Nationwide• Novartis Pharmaceuticals Corporation

Xiidra Professional Sample (Novartis) - Impurity Specifications (2022)

Failed Impurities/Degradation Specifications.

Class IIILow

FDAMay 10, 2022Nationwide• Novartis Pharmaceuticals Corporation

Xiidra Professional Sample (Novartis) - Impurity Specifications (2022)

Failed Impurities/Degradation Specifications.

Class IIILow

FDAMay 10, 2022Nationwide• Novartis Pharmaceuticals Corporation

Xiidra (Novartis) - Impurity Specifications (2022)

Failed Impurities/Degradation Specifications.

Class IIILow

FDAMay 10, 2022Nationwide• Novartis Pharmaceuticals Corporation

Promacta Oral Suspension (Novartis) – Peanut Contamination (2019)

Cross Contamination with Other Products: product is being recalled due to possible cross-contamination with peanut flour.

Class IHigh

FDAMay 11, 2019Nationwide• Novartis Pharmaceuticals Corp.

Isopto Carpine (Novartis) – Impurity Specification Failure (2017)

Failed Impurities/Degradation Specifications.

Class IIILow

FDAMar 22, 2017Nationwide• Novartis Pharmaceuticals Corp.

Pilocarpine Hydrochloride Solution (Novartis) – Impurity Specification Failure (2017)

Failed Impurities/Degradation Specifications.

Class IIILow

FDAMar 22, 2017Nationwide• Novartis Pharmaceuticals Corp.

Dexmethylphenidate HCl Extended-Release Capsules (Novartis) – Dissolution Specification Failure (...

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.

Class IIILow

FDAJul 28, 2015NJ• Novartis Pharmaceuticals Corp.

Foradil Aerolizer (Novartis) – Stability Specification Failure (2015)

Failed Stability Specification: out of specification result obtained for the Particle Size Distribution test during stability testing.

Class IIILow

FDAMay 22, 2015NJ• Novartis Pharmaceuticals Corp.

Foradil Aerolizer (Novartis) – Stability Specification Failure (2015)

Failed Stability Specification: out of specification result obtained for the Particle Size Distribution test during stability testing.

Class IIILow

FDAMay 22, 2015NJ• Novartis Pharmaceuticals Corp.

Cataflam (Novartis) – illegible tablet markings (2014)

Failed Tablet/Capsule Specifications: Ink identification had rubbed off tablets in transit making them illegible to pharmacists and consumers.

Class IIILow

FDAJul 30, 2014Nationwide• Novartis Pharmaceuticals Corp.

Foradil Aerolizer (Novartis) – failed stability test (2014)

Failed Stability Specification; out of specification result for particle size distribution during stability testing

Class IIILow

FDAMay 28, 2014Nationwide• Novartis Pharmaceuticals Corp.

Ritalin HCl (Novartis) – incorrect package insert (2014)

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

Class IIILow

FDAMar 3, 2014Nationwide• Novartis Pharmaceuticals Corp.

Ritalin HCl (Novartis) – Incorrect Package Insert (2014)

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

Class IIILow

FDAMar 3, 2014Nationwide• Novartis Pharmaceuticals Corp.

Exforge (Novartis) – Chemical Contamination (2013)

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.

Class IIModerate

FDAAug 8, 2013Nationwide• Novartis Pharmaceuticals Corp.

Exforge HCT (Novartis) – Chemical Contamination (2013)

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.

Class IIModerate

FDAAug 8, 2013Nationwide• Novartis Pharmaceuticals Corp.

Tekturna (Novartis) – Chemical Contamination (2013)

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.

Class IIModerate

FDAAug 8, 2013Nationwide• Novartis Pharmaceuticals Corp.

Stay Informed

Novartis Pharmaceuticals Corporation Recalls

Recall Summary

SANDIMMUNE Oral Solution (Novartis) – Crystallization Risk (2023)

Sandimmune Oral Solution (Novartis) – Crystallization Issue (2023)

Neoral Cyclosporine Capsules (Novartis) – Ethanol Content Issue (2022)

Xiidra (Novartis) - Impurity Specifications (2022)

Xiidra Professional Sample (Novartis) - Impurity Specifications (2022)

Xiidra Professional Sample (Novartis) - Impurity Specifications (2022)

Xiidra (Novartis) - Impurity Specifications (2022)

Promacta Oral Suspension (Novartis) – Peanut Contamination (2019)

Isopto Carpine (Novartis) – Impurity Specification Failure (2017)

Pilocarpine Hydrochloride Solution (Novartis) – Impurity Specification Failure (2017)

Dexmethylphenidate HCl Extended-Release Capsules (Novartis) – Dissolution Specification Failure (...

Foradil Aerolizer (Novartis) – Stability Specification Failure (2015)

Foradil Aerolizer (Novartis) – Stability Specification Failure (2015)

Cataflam (Novartis) – illegible tablet markings (2014)

Foradil Aerolizer (Novartis) – failed stability test (2014)

Ritalin HCl (Novartis) – incorrect package insert (2014)

Ritalin HCl (Novartis) – Incorrect Package Insert (2014)

Exforge (Novartis) – Chemical Contamination (2013)

Exforge HCT (Novartis) – Chemical Contamination (2013)

Tekturna (Novartis) – Chemical Contamination (2013)