The Recall Desk

Manufacturer

Novartis Pharmaceuticals Corp.

26 recalls in our database name Novartis Pharmaceuticals Corp. as the manufacturing or recalling firm.

What the numbers show

Total
26
Critical
1
Severe
5
Most recent
2023-09-27

Of the 26 recalls from Novartis Pharmaceuticals Corp. we have scored against our rubric, 1 (4%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 5 (19%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 26

  • SevereFDA (Drugs)·D-1174-2023·2023-09-27

    Novartis Withdraws SANDIMMUNE Oral Solution Bottles Due to Crystallization

    Novartis is recalling SANDIMMUNE Oral Solution bottles nationwide because they were found to contain crystals. Patients should contact their pharmacy or prescriber about affected bottles.

    Product
    SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL bottle, Rx Only, Manufactured by: DELPHARM Huningue S.A.S., Huningue, France, Distributed by: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936, NDC 0078-0110-22.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0678-2017·2017-05-03

    Novartis Recalls Isopto Carpine Eye Drops for Impurity Failures

    Novartis Pharmaceuticals is recalling specific lots of Isopto Carpine eye drops due to failed impurities and degradation specifications.

    Product
    Isopto Carpine (pilocarpine hydrochloride opthalmic solution) 4%, packaged in 15 mL bottle, Rx only, Manufactured by: Alcon Laboratories, Inc. Fort Worth Texas 76134 USA NDC 0998-0206-15
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1430-2015·2015-09-23

    Novartis Recalls Dexmethylphenidate HCl Extended-Release Capsules for Dissolution Failure

    Novartis Pharmaceuticals Corp. is recalling 10,767 bottles of Dexmethylphenidate HCl Extended-Release capsules because stability testing showed the product failed to meet dissolution specifications.

    Product
    Dexmethylphenidate HCl Extended-Release, Capsules, 10mg, Rx only, 100 Capsules. Manufactured by Alkermes Gainesville LLC Gainesville, GA 30504 for Sandoz Inc. Princeton, NJ 08540
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-1137-2015·2015-06-24

    Novartis Recalls Foradil Aerolizer Due to Failed Stability Testing

    Novartis is recalling Foradil Aerolizer inhalation powder because it failed a particle size distribution stability test. The recall covers 19,658 packs distributed in New Jersey.

    Product
    Foradil Aerolizer (formoterol fumarate inhalation powder) 12 mcg per capsule, 12 Capsules (Blister strips of 6) per pack. For inhalation use only, Rx only, Manufactured for: Merck Sharp & Dohme Corp., a subsidiary of MERCK & CO., INC. Whitehouse Station, NJ 08889. Manufactured
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-1138-2015·2015-06-24

    Novartis Recalls Foradil Aerolizer Inhalation Powder Due to Stability Failure

    Novartis is recalling Foradil Aerolizer inhalation powder because it failed a stability test for particle size distribution.

    Product
    Foradil Aerolizer (formoterol fumarate inhalation powder) 12 mcg per capsule, 60 Capsules (Blister strips of 6) per pack. For inhalation use only, Rx only, Manufactured for: Merck Sharp & Dohme Corp., a subsidiary of MERCK & CO., INC. Whitehouse Station, NJ 08889. Manufactured
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-1516-2014·2014-08-13

    Novartis Recalls Cataflam Tablets Due to Illegible Ink Identification

    Novartis is recalling 50 bottles of Cataflam (diclofenac potassium) 50 mg tablets because ink identification rubbed off during transit, making them illegible.

    Product
    Cataflam (diclofenac potassium) tablets, 50 mg, 100-count bottles, Rx only, Manufactured by: Patheon Inc., Whitby Operations, Ontario, Canada L1N 5Z5; Distributed by: Novartis Pharmaceuticals Corp., East Hanover, New Jersey 07936; NDC 0078-0436-05, UPC 3 0078-0436-05 2.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1387-2014·2014-06-25

    Novartis Recalls Foradil Aerolizer Due to Stability Testing Failures

    Novartis is recalling Foradil Aerolizer inhalation powder capsules because they failed stability specifications for particle size distribution.

    Product
    Foradil Aerolizer (formoterol fumarate inhalation powder), 12 mcg per capsule, 60 Capsules, Rx only, Manufactured for: Merck, Sharpe & Dohne Corp., a subsidiary of Merck & Co., Inc. Whitehouse Station, NJ 08889, Manufactured by: Novartis Pharma AG Basle, Switzerland NDC 0085-140
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1228-2014·2014-04-16

    Novartis Recalls Ritalin Tablets Due to Incorrect Medication Guide Labeling

    Novartis is recalling 10,781 bottles of Ritalin 20 mg tablets because the attached Medication Guide contained information for Ritalin SR instead of Ritalin Tablets.

    Product
    RITALIN — RITALIN (METHYLPHENIDATE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1227-2014·2014-04-16

    Novartis Recalls Ritalin Tablets Due to Incorrect Medication Guide Labeling

    Novartis is recalling Ritalin tablets because the attached Medication Guide contained information for the sustained-release version. The recall is limited to a specific lot distributed nationwide and in Puerto Rico.

    Product
    RITALIN — RITALIN (METHYLPHENIDATE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-332-2014·2013-12-18

    Novartis Recalls Exforge HCT Physician Samples Due to Chemical Contamination

    Novartis is recalling Exforge HCT physician sample bottles contaminated with Darocur 1173, a photocuring agent found in ink on shrink-wrap sleeves.

    Product
    Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) 5/160/25 mg, Rx only, 7 tablets per bottle, Physician Sample - Not For Sale. Manufactured by: Novartis Pharma Stein AG Stein, Switzerland. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-326-2014·2013-12-18

    Novartis Recalls Diovan and Other Tablets Due to Chemical Contamination

    Novartis is recalling physician sample bottles of several prescription tablets, including Diovan, due to contamination with a photocuring agent.

    Product
    Diovan (valsartan) 160 mg per tablet, 7 Tablets per bottle, Rx only Physician Sample Not For Sale, Manufactured by: Novartis Pharmaceuticals Corporation Suffern, NY 10901 for Novartis Pharmaceuticals Corporation East Hanover, NJ 07936, NDC # 0078-9359-07
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-335-2014·2013-12-18

    Novartis Recalls Lescol XL Tablets Due to Chemical Contamination

    Novartis is recalling Lescol XL tablets contaminated with Darocur 1173, a photocuring agent found in ink on shrink-wrap sleeves.

    Product
    Lescol XL (fluvastatin sodium) Extended-Release Tablets, 80 mg per tablet, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only. Manufactured by: Novartis Pharma Stein AG Stein, Switzerland. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936,
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-336-2014·2013-12-18

    Novartis Recalls Stalevo Tablets Due to Chemical Contamination

    Novartis is recalling Stalevo physician sample bottles contaminated with Darocur 1173, a photocuring agent found in ink.

    Product
    Stalevo (carbidopa, levodopa, and entacapone) 12.5/50/200 mg, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only, Manufactured by: Novartis Pharma Productions GmbH Wehr, Germany. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC # 0078
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-340-2014·2013-12-18

    Novartis Recalls Tekturna HCT Physician Samples Due to Chemical Contamination

    Novartis is recalling Tekturna HCT physician sample bottles due to contamination with Darocur 1173, a photo curing agent used in ink.

    Product
    Tekturna HCT (aliskiren and hydrochlorothiazide) Tablets 300/25 mg, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only, Manufactured by: Novartis Pharma Productions GmbH Wehr, Germany. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-338-2014·2013-12-18

    Novartis Recalls Tekturna Tablets Due to Chemical Contamination

    Novartis is recalling Tekturna physician sample bottles contaminated with Darocur 1173, a photocuring agent found in ink.

    Product
    Tekturna (aliskiren) Tablets 300 mg, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only. Manufactured by: Novartis Pharma Produktions GmbH Wehr, Germany. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC # 0078-9486-07
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-339-2014·2013-12-18

    Novartis Recalls Tekturna HCT Physician Samples Due to Chemical Contamination

    Novartis is recalling physician sample bottles of Tekturna HCT and other medications due to contamination with Darocur 1173, a photo-curing agent.

    Product
    Tekturna HCT (aliskiren and hydrochlorothiazide) Tablets 150/12.5 mg, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only, Manufactured by: Novartis Pharma Productions GmbH Wehr, Germany. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936 , ND
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-331-2014·2013-12-18

    Novartis Recalls Multiple Prescription Medications Due to Chemical Contamination

    Novartis is recalling physician sample bottles of several prescription medications due to contamination with a photocuring agent found in ink.

    Product
    Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) 5/160/12.5 mg, Rx only, 7 tablets per bottle, Physician Sample - Not For Sale. Manufactured by: Novartis Pharma Stein AG Stein, Switzerland. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, ND
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-329-2014·2013-12-18

    Novartis Recalls Exforge Physician Samples Due to Chemical Contamination

    Novartis is recalling Exforge physician sample bottles due to contamination with Darocur 1173, a photocuring agent used in ink.

    Product
    Exforge (amlodipine and valsartan Tablets) 5/320 mg, Rx only 7 tablets per bottle, Physician Sample - Not For Sale. Manufactured by: Novartis Pharma Stein AG Stein, Switzerland. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936 - NDC # 0078-9490-07
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-330-2014·2013-12-18

    Novartis Recalls Physician Sample Blood Pressure Medications Due to Chemical Contamination

    Novartis is recalling physician sample bottles of several blood pressure and cholesterol medications due to contamination with a photocuring agent used in packaging inks.

    Product
    Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) 10/320/25 mg, Rx only, 7 tablets per bottle, Physician Sample - Not For Sale. Manufactured by: Novartis Pharma Stein AG Stein, Switzerland. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-334-2014·2013-12-18

    Novartis Recalls Exforge Physician Samples Due to Chemical Contamination

    Novartis is recalling Exforge physician sample bottles due to contamination with Darocur 1173, a photocuring agent found in ink.

    Product
    Exforge (amlodipine and valsartan, Tablets) 10/320 mg, Rx only, 7 tablets per bottle, Physician Sample - Not For Sale. Manufactured by: Novartis Pharma Stein AG Stein, Switzerland. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC # 0078-9491-07
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-328-2014·2013-12-18

    Novartis Recalls Exforge Physician Samples Due to Chemical Contamination

    Novartis is recalling Exforge physician sample bottles due to contamination with Darocur 1173, a photocuring agent found in ink.

    Product
    Exforge (amlodipine and valsartan Tablets) 5/160 mg, Rx only 7 tablets per bottle, Physician Sample - Not For Sale. Manufactured by: Novartis Pharma Stein AG Stein, Switzerland. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936 - NDC # 0078-9488-07
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-337-2014·2013-12-18

    Novartis Recalls Physician Sample Tablets Due to Chemical Contamination

    Novartis is recalling physician sample bottles of several prescription medications, including Tekturna, due to contamination with a photocuring agent.

    Product
    Tekturna (aliskiren) Tablets 150 mg, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only. Manufactured by: Novartis Pharma Productions GmbH Wehr, Germany. Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC # 0078-9485-07
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-327-2014·2013-12-18

    Novartis Recalls Diovan and Other Tablets Due to Chemical Contamination

    Novartis is recalling physician sample bottles of Diovan and other tablets because they were contaminated with Darocur 1173, a photocuring agent used in inks.

    Product
    Diovan (valsartan) 320 mg per tablet, 7 Tablets per bottle, Rx only Physician Sample Not For Sale, Manufactured by: Novartis Pharmaceuticals Corporation Suffern, NY 10901 for Novartis Pharmaceuticals Corporation East Hanover, NJ 07936, NDC # 0078-9360-07
    Category
    Drug
    Distribution
    Distributed nationwide