Novartis Pharmaceuticals recalls
Novartis Pharmaceuticals appears in 34 official U.S. recall notices indexed by RecallRadar, most recently on 2026-08-19.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 34 |
|---|---|
| Published | 2013-12-18 to 2026-08-19 |
| By agency | FDA Drug (33), CPSC (1) |
| By classification | Class II (17), Class III (13), Class I (3) |
| By status | terminated (30), ongoing (3) |
| Distribution named in notices | NJ, US |
Recalls
- Diovan (valsartan) 160 mg, 90 tablets, Rx only, Manufactured by: Patheon Manufacturing Services LLC, Greenville, NC 27834, Distributed by:…
FDA Drug · Class II · 2026-08-19 · Novartis Pharmaceuticals
Reason: Failed Dissolution Specifications - SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL bottle, Rx Only, Manufactured by: DELPHARM Huningue S.A.S., Hun…
FDA Drug · Class I · 2023-12-13 · Novartis Pharmaceuticals
Reason: Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals - SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL bottle, Rx Only, Manufactured by: DELPHARM Huningue S.A.S., Hun…
FDA Drug · Class I · 2023-09-27 · Novartis Pharmaceuticals
Reason: Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals. - Neoral soft gelatin capsules (cyclosporine capsules, USP) Modified, 25 mg, Rx Only, 30 Soft Gelatin Capsules per carton, Mfg by: Novartis P…
FDA Drug · Class II · 2022-10-05 · Novartis Pharmaceuticals
Reason: CGMP deviations: Out of specification results obtained during routine stability testing for ethanol content. - Xiidra (lifitegrast ophthalmic solution) 5%, packaged in a) 60 Single-Use Containers: 12 pouches x 5 single-use containers (0.2 mL each via…
FDA Drug · Class III · 2022-06-15 · Novartis Pharmaceuticals
Reason: Failed Impurities/Degradation Specifications. - Xiidra (lifitegrast ophthalmic solution), packaged in a) 60 Single-Use Containers: 12 pouches x 5 single-use containers (0.2 mL each vial)…
FDA Drug · Class III · 2022-06-15 · Novartis Pharmaceuticals
Reason: Failed Impurities/Degradation Specifications. - Xiidra (lifitegrast ophthalmic solution) 5% PROFESSIONAL SAMPLE, packaged in a) 5 single-use containers (0.2 mL each vial) (NDC 0078-0911-9…
FDA Drug · Class III · 2022-06-15 · Novartis Pharmaceuticals
Reason: Failed Impurities/Degradation Specifications. - Xiidra (lifitegrast ophthalmic solution) 5% PROFESSIONAL SAMPLE, packaged in a) 5 single-use containers (0.2 mL each vial) (NDC 54092-606-0…
FDA Drug · Class III · 2022-06-15 · Novartis Pharmaceuticals
Reason: Failed Impurities/Degradation Specifications. - Sandimmune® (cyclosporine capsules, USP) 100 mg soft gelatin capsules and Neoral® (cyclosporine capsules, USP) MODIFIED 100 mg soft gelatin…
CPSC · 2020-03-18 · Novartis Pharmaceuticals
Reason: The prescription drug packaging is not child resistant as required by the Poison Prevention Packaging Act (PPPA), posing a risk of poisoning if the contents are swallowed by young children. - Promacta (eltrombopag) 12.5 mg for Oral Suspension, Rx Only Manufactured by: Halo Pharmaceuticals, Inc
FDA Drug · Class I · 2019-05-29 · Novartis Pharmaceuticals
Reason: Cross Contamination with Other Products: product is being recalled due to possible cross-contamination with peanut flour. - Pilocarpine Hydrochloride Ophthalmic Solution 4% , packaged in 15 mL bottles, Rx Only, Manufactured by Alcon Laboratories, Inc
FDA Drug · Class III · 2017-05-03 · Novartis Pharmaceuticals
Reason: Failed Impurities/Degradation Specifications. - Isopto Carpine (pilocarpine hydrochloride opthalmic solution) 4%, packaged in 15 mL bottle, Rx only, Manufactured by: Alcon Laboratories, I…
FDA Drug · Class III · 2017-05-03 · Novartis Pharmaceuticals
Reason: Failed Impurities/Degradation Specifications. - Dexmethylphenidate HCl Extended-Release, Capsules, 10mg, Rx only, 100 Capsules
FDA Drug · Class III · 2015-09-23 · Novartis Pharmaceuticals
Reason: 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. - Foradil Aerolizer (formoterol fumarate inhalation powder) 12 mcg per capsule, 60 Capsules (Blister strips of 6) per pack
FDA Drug · Class III · 2015-06-24 · Novartis Pharmaceuticals
Reason: Failed Stability Specification: out of specification result obtained for the Particle Size Distribution test during stability testing. - Foradil Aerolizer (formoterol fumarate inhalation powder) 12 mcg per capsule, 12 Capsules (Blister strips of 6) per pack
FDA Drug · Class III · 2015-06-24 · Novartis Pharmaceuticals
Reason: Failed Stability Specification: out of specification result obtained for the Particle Size Distribution test during stability testing. - Cataflam (diclofenac potassium) tablets, 50 mg, 100-count bottles, Rx only, Manufactured by: Patheon Inc., Whitby Operations, Ontario, Cana…
FDA Drug · Class III · 2014-08-13 · Novartis Pharmaceuticals
Reason: Failed Tablet/Capsule Specifications: Ink identification had rubbed off tablets in transit making them illegible to pharmacists and consumers. - Foradil Aerolizer (formoterol fumarate inhalation powder), 12 mcg per capsule, 60 Capsules, Rx only, Manufactured for: Merck, Sharpe & Dohn…
FDA Drug · Class III · 2014-06-25 · Novartis Pharmaceuticals
Reason: Failed Stability Specification; out of specification result for particle size distribution during stability testing - Ritalin HCl (methylphenidate HCl) USP, 10 mg, 100 tablets per Bottle, Rx only, Mfd. by: Novartis Pharmaceuticals Corp
FDA Drug · Class III · 2014-04-16 · Novartis Pharmaceuticals
Reason: 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 pro… - Ritalin HCl (methylphenidate HCl) USP, 20 mg, 100 tablets per Bottle, Rx only, Mfd. by: Novartis Pharmaceuticals Corp
FDA Drug · Class III · 2014-04-16 · Novartis Pharmaceuticals
Reason: 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 pro… - Lescol XL (fluvastatin sodium) Extended-Release Tablets, 80 mg per tablet, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only
FDA Drug · Class II · 2013-12-18 · Novartis Pharmaceuticals
Reason: 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… - Exforge (amlodipine and valsartan Tablets) 5/160 mg, Rx only 7 tablets per bottle, Physician Sample - Not For Sale
FDA Drug · Class II · 2013-12-18 · Novartis Pharmaceuticals
Reason: 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… - Tekturna (aliskiren) Tablets 150 mg, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only
FDA Drug · Class II · 2013-12-18 · Novartis Pharmaceuticals
Reason: 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… - Tekturna HCT (aliskiren and hydrochlorothiazide) Tablets 150/12.5 mg, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only, Manufac…
FDA Drug · Class II · 2013-12-18 · Novartis Pharmaceuticals
Reason: 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… - Exforge (amlodipine and valsartan, Tablets) 10/320 mg, Rx only, 7 tablets per bottle, Physician Sample - Not For Sale
FDA Drug · Class II · 2013-12-18 · Novartis Pharmaceuticals
Reason: 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… - Diovan (valsartan) 160 mg per tablet, 7 Tablets per bottle, Rx only Physician Sample Not For Sale, Manufactured by: Novartis Pharmaceutical…
FDA Drug · Class II · 2013-12-18 · Novartis Pharmaceuticals
Reason: 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… - Diovan (valsartan) 320 mg per tablet, 7 Tablets per bottle, Rx only Physician Sample Not For Sale, Manufactured by: Novartis Pharmaceutical…
FDA Drug · Class II · 2013-12-18 · Novartis Pharmaceuticals
Reason: 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… - Stalevo (carbidopa, levodopa, and entacapone) 12.5/50/200 mg, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only, Manufactured by…
FDA Drug · Class II · 2013-12-18 · Novartis Pharmaceuticals
Reason: 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… - Exforge (amlodipine and valsartan Tablets) 5/320 mg, Rx only 7 tablets per bottle, Physician Sample - Not For Sale
FDA Drug · Class II · 2013-12-18 · Novartis Pharmaceuticals
Reason: 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… - Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) 5/160/12.5 mg, Rx only, 7 tablets per bottle, Physician Sample - Not For Sale
FDA Drug · Class II · 2013-12-18 · Novartis Pharmaceuticals
Reason: 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… - Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) 5/160/25 mg, Rx only, 7 tablets per bottle, Physician Sample - Not For Sale
FDA Drug · Class II · 2013-12-18 · Novartis Pharmaceuticals
Reason: 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… - Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) 10/320/25 mg, Rx only, 7 tablets per bottle, Physician Sample - Not For Sale
FDA Drug · Class II · 2013-12-18 · Novartis Pharmaceuticals
Reason: 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… - Tekturna (aliskiren) Tablets 300 mg, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only
FDA Drug · Class II · 2013-12-18 · Novartis Pharmaceuticals
Reason: 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… - Tekturna HCT (aliskiren and hydrochlorothiazide) Tablets 300/25 mg, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only, Manufactu…
FDA Drug · Class II · 2013-12-18 · Novartis Pharmaceuticals
Reason: 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… - Exforge (amlodipine and valsartan Tablets) 10/160 mg, Rx only, 7 tablets per bottle, Physician Sample - Not For Sale
FDA Drug · Class II · 2013-12-18 · Novartis Pharmaceuticals
Reason: 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…