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Apotex Inc.

FDA Regulatory Profile

Apotex Inc. has 76 FDA recalls (6 Class I), 39 inspections, 0 510(k) clearances and 4 compliance actions on record.

What these totals cover: FDA records filed under the name "Apotex Inc." and its spelling variant "Apotex".

Latest recall
D-0877-2026 · Class II · Sep 23, 2026
Latest inspection
Sep 25, 2026 · NAI

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls76 (6 Class I)Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections39Nov 13, 2026Newest record Nov 5, 2026Current
Compliance actions4Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

Apotex Inc.'s FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Apotex Inc.: FDA inspections per year 2017: 3 inspections320172018: 1 inspections120182019: 6 inspections620192020: 0 inspections020202021: 0 inspections020212022: 3 inspections320222023: 1 inspections120232024: 3 inspections320242025: 3 inspections320252026: 1 inspections12026
YearInspectionsOAIWarning lettersRecall recordsClass I
202610040
202531160
202430010
202310060
202230030
202100032
202000020
201960080
201810032
201730010

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.

Recent recalls

76 recall records from Jun 14, 2007 to Sep 23, 2026. Showing the 20 most recent. View all 76 recall records

NumberClassProductDate
D-0877-2026Class IIParoxetine Extended-Release Tablets, 37.5mg, 30-count bottle, Rx only, Manufactured by: Apotex Inc…Sep 23, 2026
D-0804-2026Class IIPaxil CR, Paroxetine, Extended-Release Tablets, 37.5mg, 30 count bottle, Rx only, Manufactured by…Aug 13, 2026
D-0510-2026Class IIDesmopressin Nasal Spray, USP, 10 mcg/0.1 mL, 5 mL bottle (50 doses), Rx only, Mfg by: Apotek inc…Apr 8, 2026
D-0407-2026Class IIBrimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%*, 5 mL, Rx Only, Sterile, Apotex…Mar 5, 2026
D-0676-2025Class IIBrimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, a) 5 mL and b) 10 mL, Rx Only…Sep 5, 2025
D-0677-2025Class IIKetorolac Tromethamine Ophthalmic Solution, 0.5%, 5 mL, Rx Only, Sterile, Manufactured by: Apotex…Sep 5, 2025
D-0494-2025Class IIKetorolac Tromethamine Ophthalmic Solution, 0.5%, 10 mL, Rx Only, Manufactured by: Apotex Inc…May 28, 2025
D-0457-2025Class IILacosamide Oral Solution, USP, 10 mg/mL, 200 mL, Rx Only, Manufactured by: Apotex Inc., Toronto…May 28, 2025
D-0496-2025Class IIBrimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, 15 mL, Rx Only, Sterile…May 28, 2025
D-0495-2025Class IIAzelastine HCl Ophthalmic Solution, USP, 0.05%, 6 mL, Rx Only, Sterile, Mfg. by: Apotex Inc…May 28, 2025
D-0326-2024Class IIFluticasone Propionate Nasal Spray USP 50mcg, 120 Metered Sprays - 16 g net fill, Rx Only…Feb 9, 2024
D-0121-2024Class IIParoxetine Hydrochloride Tablets USP, RX only, 30 mg, a)30-count bottle, NDC#: 60505-0084-1…Nov 1, 2023
D-0119-2024Class IIParoxetine Hydrochloride Tablets USP, RX only, 10 mg a) 30-count bottle, NDC#: 60505-0097-1; b)…Nov 1, 2023
D-0122-2024Class IIParoxetine Hydrochloride Tablets USP, RX only, 40 mg, 1000-count bottle, NDC#:60505-0101-4…Nov 1, 2023
D-0120-2024Class IIParoxetine Hydrochloride Tablets USP, RX only, 20 mg, a) 100-count bottle, NDC#:60505-0083-2; b)…Nov 1, 2023
D-0568-2023Class IICalcitonin Salmon (synthetic origin) Nasal Spray, 2200 USP Calcitonin Salmon Units/mL, 200 USP…Apr 26, 2023
D-0433-2023Class IIBrimonidine Tartrate Ophthalmic Solution 0.15%, Rx Only, Packaged as: a) 5 mL dropper bottle, NDC…Mar 1, 2023
D-0093-2023Class IIITimolol Maleate Ophthalmic Solution, USP 0.5%, 2.5 mL, Rx Only, Mfg by: Apotex Inc. Toronto, Ontario…Dec 21, 2022
D-1285-2022Class IIAripiprazole Tablets, USP 20 mg, packaged in a) 1,000-count bottle (NDC 60505-2676-8, UPC 3 60505…Jul 7, 2022
D-0881-2022Class IIISirolimus Oral Solution, 1 mg/mL, 60 mL bottle, Rx Only, Manufactured by: Apotex Inc. Toronto…May 3, 2022

Recent FDA inspections

39 inspections from Dec 19, 2008 to Sep 25, 2026. Showing the 20 most recent. View all 39 inspections

DateSiteProductClassificationFEI
Sep 25, 2026North York, CanadaDrugsNo Action Indicated (NAI)3002906944
Jul 31, 2025North York, CanadaDrugsNo Action Indicated (NAI)3002906944
May 9, 2025Richmond Hill, CanadaDrugsOfficial Action Indicated (OAI)3001617666
May 9, 2025Brantford, CanadaDrugsVoluntary Action Indicated (VAI)3000114091
Sep 27, 2024Etobicoke, CanadaDrugsNo Action Indicated (NAI)3002808376
Mar 8, 2024Richmond Hill, CanadaDrugsNo Action Indicated (NAI)3001617666
Feb 23, 2024Etobicoke, CanadaDrugsNo Action Indicated (NAI)3002808376
Mar 24, 2023Richmond Hill, CanadaDrugsNo Action Indicated (NAI)3001617666
Dec 16, 2022Brantford, CanadaDrugsVoluntary Action Indicated (VAI)3000114091
Sep 23, 2022North York, CanadaDrugsNo Action Indicated (NAI)3002906944
Sep 14, 2022Richmond Hill, CanadaDrugsVoluntary Action Indicated (VAI)3001617666
Nov 8, 2019Etobicoke, CanadaDrugsNo Action Indicated (NAI)3002808376
Jul 12, 2019Etobicoke, CanadaDrugsVoluntary Action Indicated (VAI)3002808376
Jun 28, 2019Richmond Hill, CanadaDrugsNo Action Indicated (NAI)3001617666
Jun 19, 2019North York, CanadaDrugsNo Action Indicated (NAI)3002906944
May 24, 2019Brantford, CanadaDrugsNo Action Indicated (NAI)3000114091
Mar 22, 2019Richmond Hill, CanadaDrugsNo Action Indicated (NAI)3001617666
May 10, 2018North York, CanadaDrugsNo Action Indicated (NAI)3002906944
Dec 8, 2017Etobicoke, CanadaDrugsNo Action Indicated (NAI)3002808376
Jun 14, 2017North York, CanadaDrugsVoluntary Action Indicated (VAI)3002906944
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 4 compliance actions under Apotex Inc.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Oct 31, 2025.

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

FDA-inspected facilities

6 inspected sites, newest inspection first.

FacilityLocationInspectionsLatest
FEI 3002906944North York, Canada11Sep 25, 2026
FEI 3000114091Brantford, Canada6May 9, 2025
FEI 3001617666Richmond Hill, Canada11May 9, 2025
FEI 3002808376Etobicoke, Canada9Sep 27, 2024
FEI 3006727872Weston, FL1Aug 10, 2011
FEI 3005072567Toronto, Canada1Jul 29, 2009

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FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.