Novartis Pharmaceuticals Corporation FDA Record
Novartis Pharmaceuticals Corporation has 33 FDA recalls (3 Class I), 54 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Novartis Pharmaceuticals Corporation" is on file.
- Latest recall
- D-0746-2026 · Class II · Aug 4, 2026
- Latest inspection
- Jun 24, 2026 · NAI
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 33 (3 Class I) | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 54 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 2 | 0 | 0 | 1 | 0 |
| 2025 | 3 | 0 | 0 | 0 | 0 |
| 2024 | 4 | 0 | 0 | 0 | 0 |
| 2023 | 3 | 0 | 0 | 2 | 2 |
| 2022 | 1 | 0 | 0 | 5 | 0 |
| 2021 | 2 | 0 | 0 | 0 | 0 |
| 2020 | 1 | 0 | 0 | 0 | 0 |
| 2019 | 3 | 0 | 0 | 1 | 1 |
| 2018 | 3 | 0 | 0 | 0 | 0 |
| 2017 | 2 | 0 | 0 | 2 | 0 |
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Recent recalls
| Number | Class | Product | Date |
|---|---|---|---|
| D-0746-2026 | Class II | Diovan (valsartan) 160 mg, 90 tablets, Rx only, Manufactured by: Patheon Manufacturing Services LLC… | Aug 4, 2026 |
| D-0144-2024 | Class I | SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL bottle, Rx Only… | Nov 22, 2023 |
| D-1174-2023 | Class I | SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL bottle, Rx Only… | Sep 8, 2023 |
| D-1543-2022 | Class II | Neoral soft gelatin capsules (cyclosporine capsules, USP) Modified, 25 mg, Rx Only, 30 Soft Gelatin… | Sep 16, 2022 |
| D-0983-2022 | Class III | Xiidra (lifitegrast ophthalmic solution) 5%, packaged in a) 60 Single-Use Containers: 12 pouches x 5… | May 10, 2022 |
| D-0982-2022 | Class III | Xiidra (lifitegrast ophthalmic solution), packaged in a) 60 Single-Use Containers: 12 pouches x 5… | May 10, 2022 |
| D-0984-2022 | Class III | Xiidra (lifitegrast ophthalmic solution) 5% PROFESSIONAL SAMPLE, packaged in a) 5 single-use… | May 10, 2022 |
| D-0985-2022 | Class III | Xiidra (lifitegrast ophthalmic solution) 5% PROFESSIONAL SAMPLE, packaged in a) 5 single-use… | May 10, 2022 |
| D-1309-2019 | Class I | Promacta (eltrombopag) 12.5 mg for Oral Suspension, Rx Only Manufactured by: Halo Pharmaceuticals… | May 11, 2019 |
| D-0679-2017 | Class III | Pilocarpine Hydrochloride Ophthalmic Solution 4% , packaged in 15 mL bottles, Rx Only, Manufactured… | Mar 22, 2017 |
| D-0678-2017 | Class III | Isopto Carpine (pilocarpine hydrochloride opthalmic solution) 4%, packaged in 15 mL bottle, Rx only… | Mar 22, 2017 |
| D-1430-2015 | Class III | Dexmethylphenidate HCl Extended-Release, Capsules, 10mg, Rx only, 100 Capsules. Manufactured by… | Jul 28, 2015 |
| D-1138-2015 | Class III | Foradil Aerolizer (formoterol fumarate inhalation powder) 12 mcg per capsule, 60 Capsules (Blister… | May 22, 2015 |
| D-1137-2015 | Class III | Foradil Aerolizer (formoterol fumarate inhalation powder) 12 mcg per capsule, 12 Capsules (Blister… | May 22, 2015 |
| D-1516-2014 | Class III | Cataflam (diclofenac potassium) tablets, 50 mg, 100-count bottles, Rx only, Manufactured by: Patheon… | Jul 30, 2014 |
| D-1387-2014 | Class III | Foradil Aerolizer (formoterol fumarate inhalation powder), 12 mcg per capsule, 60 Capsules, Rx only… | May 28, 2014 |
| D-1227-2014 | Class III | Ritalin HCl (methylphenidate HCl) USP, 10 mg, 100 tablets per Bottle, Rx only, Mfd. by: Novartis… | Mar 3, 2014 |
| D-1228-2014 | Class III | Ritalin HCl (methylphenidate HCl) USP, 20 mg, 100 tablets per Bottle, Rx only, Mfd. by: Novartis… | Mar 3, 2014 |
| D-337-2014 | Class II | Tekturna (aliskiren) Tablets 150 mg, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only… | Aug 8, 2013 |
| D-336-2014 | Class II | Stalevo (carbidopa, levodopa, and entacapone) 12.5/50/200 mg, 7 tablets per bottle, Physician… | Aug 8, 2013 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Jun 24, 2026 | East Hanover, NJ | Drugs | No Action Indicated (NAI) | 2210396 |
| Feb 6, 2026 | Morris Plains, NJ | Biologics | Voluntary Action Indicated (VAI) | 3010353512 |
| Jul 11, 2025 | Targu Mures, Romania | Drugs | Voluntary Action Indicated (VAI) | 3005587283 |
| Jun 25, 2025 | East Hanover, NJ | Drugs | No Action Indicated (NAI) | 2210396 |
| Mar 3, 2025 | East Hanover, NJ | Drugs | No Action Indicated (NAI) | 2210396 |
| Nov 19, 2024 | East Hanover, NJ | Drugs | No Action Indicated (NAI) | 2210396 |
| Aug 29, 2024 | East Hanover, NJ | Drugs | No Action Indicated (NAI) | 2210396 |
| Aug 8, 2024 | Morris Plains, NJ | Biologics | Voluntary Action Indicated (VAI) | 3010353512 |
| Jun 27, 2024 | East Hanover, NJ | Drugs | No Action Indicated (NAI) | 2210396 |
| Aug 26, 2023 | Targu Mures, Romania | Drugs | Voluntary Action Indicated (VAI) | 3005587283 |
| Aug 21, 2023 | East Hanover, NJ | Drugs | Voluntary Action Indicated (VAI) | 2210396 |
| Jun 13, 2023 | East Hanover, NJ | Drugs | No Action Indicated (NAI) | 2210396 |
| Dec 9, 2022 | Morris Plains, NJ | Biologics | Voluntary Action Indicated (VAI) | 3010353512 |
| Jul 9, 2021 | East Hanover, NJ | Drugs | No Action Indicated (NAI) | 2210396 |
| Mar 3, 2021 | East Hanover, NJ | Drugs | No Action Indicated (NAI) | 2210396 |
| Jul 2, 2020 | East Hanover, NJ | Drugs | No Action Indicated (NAI) | 2210396 |
| Aug 21, 2019 | Morris Plains, NJ | Biologics | Voluntary Action Indicated (VAI) | 3010353512 |
| Jul 2, 2019 | East Hanover, NJ | Drugs | Voluntary Action Indicated (VAI) | 2210396 |
| Feb 21, 2019 | East Hanover, NJ | Drugs | No Action Indicated (NAI) | 2210396 |
| Dec 14, 2018 | East Hanover, NJ | Drugs | Voluntary Action Indicated (VAI) | 2210396 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 2210396 | East Hanover, NJ | 30 | Jun 24, 2026 |
| FEI 3010353512 | Morris Plains, NJ | 4 | Feb 6, 2026 |
| FEI 3005587283 | Targu Mures, Romania | 4 | Jul 11, 2025 |
| FEI 2416082 | Suffern, NY | 9 | Jul 14, 2015 |
| FEI 3000215618 | Vacaville, CA | 7 | Nov 2, 2012 |
Novartis Pharmaceuticals Corporation and the FDA: common questions
Has Novartis Pharmaceuticals Corporation received an FDA warning letter?
No FDA warning letter addressed to the name "Novartis Pharmaceuticals Corporation" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Novartis Pharmaceuticals Corporation received an FDA Form 483?
FDA has not published a Form 483 for "Novartis Pharmaceuticals Corporation" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Novartis Pharmaceuticals Corporation?
The most recent FDA inspection on file ended Jun 24, 2026 at East Hanover, NJ and was classified NAI. FDA has 54 inspections of Novartis Pharmaceuticals Corporation on file.
Has Novartis Pharmaceuticals Corporation had an FDA recall?
Yes. Novartis Pharmaceuticals Corporation has 33 FDA recalls on record, 3 of them Class I, the most serious class. The most recent started Aug 4, 2026.
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