Novartis Pharmaceuticals Corp.
Complete recall history across all FDA and CPSC categories, 26 total recalls
Novartis Pharmaceuticals Corp. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Drug Recalls (26)
FDA drug safety enforcement actions by Novartis Pharmaceuticals Corp.
| Date | Product | Reason | Class |
|---|---|---|---|
| Sep 8, 2023 | SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL b... | Crystallization: bottles of Sandimmune Oral Solution were determined to conta... | Class I |
| May 11, 2019 | Promacta (eltrombopag) 12.5 mg for Oral Suspension, Rx Only Manufactured by:... | Cross Contamination with Other Products: product is being recalled due to pos... | Class I |
| Mar 22, 2017 | Pilocarpine Hydrochloride Ophthalmic Solution 4% , packaged in 15 mL bottles,... | Failed Impurities/Degradation Specifications. | Class III |
| Mar 22, 2017 | Isopto Carpine (pilocarpine hydrochloride opthalmic solution) 4%, packaged in... | Failed Impurities/Degradation Specifications. | Class III |
| Jul 28, 2015 | Dexmethylphenidate HCl Extended-Release, Capsules, 10mg, Rx only, 100 Capsule... | Failed Dissolution Specifications: Product is being recalled due to out of sp... | Class III |
| May 22, 2015 | Foradil Aerolizer (formoterol fumarate inhalation powder) 12 mcg per capsule,... | Failed Stability Specification: out of specification result obtained for the ... | Class III |
| May 22, 2015 | Foradil Aerolizer (formoterol fumarate inhalation powder) 12 mcg per capsule,... | Failed Stability Specification: out of specification result obtained for the ... | Class III |
| Jul 30, 2014 | Cataflam (diclofenac potassium) tablets, 50 mg, 100-count bottles, Rx only, M... | Failed Tablet/Capsule Specifications: Ink identification had rubbed off table... | Class III |
| May 28, 2014 | Foradil Aerolizer (formoterol fumarate inhalation powder), 12 mcg per capsule... | Failed Stability Specification; out of specification result for particle size... | Class III |
| Mar 3, 2014 | Ritalin HCl (methylphenidate HCl) USP, 20 mg, 100 tablets per Bottle, Rx only... | Labeling: Incorrect or Missing Package Insert; The back of the Medication Gui... | Class III |
| Mar 3, 2014 | Ritalin HCl (methylphenidate HCl) USP, 10 mg, 100 tablets per Bottle, Rx only... | Labeling: Incorrect or Missing Package Insert; The back of the Medication Gui... | Class III |
| Aug 8, 2013 | Tekturna (aliskiren) Tablets 300 mg, 7 tablets per bottle, Physician Sample-N... | Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled phy... | Class II |
| Aug 8, 2013 | Exforge (amlodipine and valsartan Tablets) 5/320 mg, Rx only 7 tablets per bo... | Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled phy... | Class II |
| Aug 8, 2013 | Tekturna HCT (aliskiren and hydrochlorothiazide) Tablets 300/25 mg, 7 tablets... | Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled phy... | Class II |
| Aug 8, 2013 | Diovan (valsartan) 320 mg per tablet, 7 Tablets per bottle, Rx only Physicia... | Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled phy... | Class II |
| Aug 8, 2013 | Lescol XL (fluvastatin sodium) Extended-Release Tablets, 80 mg per tablet, 7 ... | Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled phy... | Class II |
| Aug 8, 2013 | Tekturna HCT (aliskiren and hydrochlorothiazide) Tablets 150/12.5 mg, 7 table... | Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled phy... | Class II |
| Aug 8, 2013 | Diovan (valsartan) 160 mg per tablet, 7 Tablets per bottle, Rx only Physicia... | Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled phy... | Class II |
| Aug 8, 2013 | Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) 10/320/25 mg, Rx onl... | Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled phy... | Class II |
| Aug 8, 2013 | Exforge (amlodipine and valsartan, Tablets) 10/320 mg, Rx only, 7 tablets per... | Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled phy... | Class II |
| Aug 8, 2013 | Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) 5/160/12.5 mg, Rx on... | Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled phy... | Class II |
| Aug 8, 2013 | Exforge (amlodipine and valsartan Tablets) 10/160 mg, Rx only, 7 tablets per ... | Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled phy... | Class II |
| Aug 8, 2013 | Exforge (amlodipine and valsartan Tablets) 5/160 mg, Rx only 7 tablets per bo... | Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled phy... | Class II |
| Aug 8, 2013 | Stalevo (carbidopa, levodopa, and entacapone) 12.5/50/200 mg, 7 tablets per b... | Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled phy... | Class II |
| Aug 8, 2013 | Tekturna (aliskiren) Tablets 150 mg, 7 tablets per bottle, Physician Sample-N... | Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled phy... | Class II |
| Aug 8, 2013 | Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) 5/160/25 mg, Rx only... | Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled phy... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious, there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious, the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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