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Sun Pharma Canada Inc.

FDA Regulatory Profile

Sun Pharma Canada Inc. has 0 FDA recalls, 7 inspections, 0 510(k) clearances and 1 compliance action on record.

What these totals cover: FDA records filed under the name "Sun Pharma Canada Inc." and its spelling variant "Sun Pharma Canada". Records filed under related names are not included; see Related names.

Latest inspection: Mar 27, 2026 · NAI

Newer recall under related name Sun Pharmaceutical Industries: Sep 25, 2026, D-0035-2027.

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Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 8, 2026	File dated Nov 3, 2026	Current
510(k) clearances	0	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	7	Nov 13, 2026	Newest record Nov 5, 2026	Current
Compliance actions	1	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Sun Pharma Canada Inc.'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	1	0	0	0	0
2025	0	0	0	0	0
2024	1	0	0	0	0
2023	0	0	0	0	0
2022	1	0	0	0	0
2021	0	0	0	0	0
2020	0	0	0	0	0
2019	1	0	0	0	0
2018	0	0	0	0	0
2017	0	0	0	0	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 Sun Pharma Canada Inc. above.

Name	Relation	Recalls	510(k)	Inspections	Compliance actions	Most recent recall
Sun Pharmaceutical Industries	Same company group	141	1	80	5	Sep 25, 2026 (D-0035-2027)
Pharmalucence	Same company group	3	0	0	0	Jun 6, 2018 (D-1040-2018)
Ohm Laboratories	Same company group	23	0	25	1	Jul 28, 2015 (D-0039-2016)
Taro Pharmaceutical Industries	Same company group	0	0	7	0	—

Recent FDA inspections

7 inspections from Feb 11, 2011 to Mar 27, 2026.

Date	Site	Product	Classification	FEI
Mar 27, 2026	Brampton, Canada	Drugs	No Action Indicated (NAI)	3002808384
Sep 20, 2024	Brampton, Canada	Drugs	No Action Indicated (NAI)	3002808384
Sep 16, 2022	Brampton, Canada	Drugs	Voluntary Action Indicated (VAI)	3002808384
May 3, 2019	Brampton, Canada	Drugs	Voluntary Action Indicated (VAI)	3002808384
Jul 29, 2016	Brampton, Canada	Drugs	No Action Indicated (NAI)	3002808384
Feb 28, 2014	Brampton, Canada	Drugs	Voluntary Action Indicated (VAI)	3002808384
Feb 11, 2011	Brampton, Canada	Drugs	Voluntary Action Indicated (VAI)	3002808384

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.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

Compliance Actions

FDA's compliance actions data lists 1 compliance action under Sun Pharma Canada Inc.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Feb 5, 2009.

Individual actions are not listed on this page. Search them with the FDA warning letter search or browse all compliance actions.

FDA-inspected facilities

1 inspected site, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3002808384	Brampton, Canada	7	Mar 27, 2026

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