Novartis Pharmaceuticals Corporation

FDA Regulatory Profile

Novartis Pharmaceuticals Corporation appears in FDA public data with 7 recalls — including 1 Class I (most serious) —, 0 510(k) clearances, 39 FDA inspections, and 0 compliance actions on record. Its most recent recall (D-0746-2026, Class II) was initiated on August 4, 2026.

Summary

Total Recalls
7 (1 Class I)
510(k) Clearances
0
Inspections
39
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0746-2026Class IIDiovan (valsartan) 160 mg, 90 tablets, Rx only, Manufactured by: Patheon Manufacturing Services LLC,August 4, 2026
D-0144-2024Class ISANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL bottle, Rx Only, ManufacNovember 22, 2023
D-1543-2022Class IINeoral soft gelatin capsules (cyclosporine capsules, USP) Modified, 25 mg, Rx Only, 30 Soft Gelatin September 16, 2022
D-0985-2022Class IIIXiidra (lifitegrast ophthalmic solution) 5% PROFESSIONAL SAMPLE, packaged in a) 5 single-use containMay 10, 2022
D-0983-2022Class IIIXiidra (lifitegrast ophthalmic solution) 5%, packaged in a) 60 Single-Use Containers: 12 pouches x 5May 10, 2022
D-0984-2022Class IIIXiidra (lifitegrast ophthalmic solution) 5% PROFESSIONAL SAMPLE, packaged in a) 5 single-use containMay 10, 2022
D-0982-2022Class IIIXiidra (lifitegrast ophthalmic solution), packaged in a) 60 Single-Use Containers: 12 pouches x 5 siMay 10, 2022