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Novartis Pharmaceuticals Corporation
FDA Regulatory Profile
Novartis Pharmaceuticals Corporation has 33 FDA recalls (3 Class I), 54 inspections, 0 510(k) clearances and 0 compliance actions on record.
What these totals cover: FDA records filed under the name "Novartis Pharmaceuticals Corporation" and its spelling variant "Novartis Pharmaceuticals". Records filed under related names are not included; see Related names.
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Record counts and when each FDA source was last refreshed
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 13, 2026
Newest record Nov 5, 2026
Current
Compliance actions
0
Nov 2, 2026
Newest record Oct 29, 2026
Current
FDA record by year
Novartis Pharmaceuticals Corporation's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).
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
Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.
Related names
Each name below has its own page. Its counts cover only the records FDA filed under that name and are not part of the totals for Novartis Pharmaceuticals Corporation above.
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