Apotex Corp.

• ParoxetinePaxil, Paxil CR, Brisdelle · 14 products
• OlanzapineZyprexa, Zyprexa Zydis, Olanzapine Intramuscular · 10 products
• Amlodipine and atorvastatinCaduet · 8 products
• AtomoxetineStrattera, Atoncy · 7 products
• Lisdexamfetamine dimesylateVyvanse, Arynta · 7 products
• DexamethasoneTaperdex 6-Day, Hemady, Taperdex 12-Day · 7 products
• Sotalol hydrochlorideBetapace, Sotalol Hydrochloride Af, Betapace Af · 7 products
• CyclosporineSandimmune, Neoral, Cyclosporine Modified · 6 products
• DasatinibSprycel, Phyrago · 6 products
• Cefazolin6 products
• LenalidomideRevlimid · 6 products
• CefepimeCefepime Hydrochloride and Dextrose · 6 products
• Ceftriaxone sodiumCeftriaxone and Dextrose · 5 products
• TizanidineZanaflex, Ontralfy · 5 products
• BrivaracetamBriviact · 5 products
• Etodolac4 products
• ZiprasidoneGeodon · 4 products
• AtorvastatinLipitor · 4 products
• Piperacillin and tazobactamZosyn in Galaxy Containers, Zosyn · 4 products
• OmeprazolePrilosec · 4 products
• Varenicline tartrateChantix, Tyrvaya · 4 products
• PomalidomidePomalyst · 4 products
• Pravastatin sodium4 products
• GuanfacineIntuniv · 4 products
• Eslicarbazepine acetateAptiom · 4 products
• ArmodafinilNuvigil · 4 products
• Ceftaroline fosamilTeflaro · 4 products
• DoxazosinCardura, Cardura XL · 4 products
• CarbamazepineTegretol XR, Equetro, Carbatrol · 4 products
• Trazodone hydrochlorideRaldesy Tm · 4 products
• TolvaptanJynarque, Samsca · 4 products
• ModafinilProvigil · 4 products
• DiltiazemTiadylt ER, Cartia Xt, Tiazac Extended Release · 3 products
• LamivudineEpivir · 3 products
• OxcarbazepineTrileptal, Oxtellar XR · 3 products
• PrasugrelEffient · 3 products
• Clorazepate dipotassium3 products
• AcyclovirZovirax, Avaclyr · 3 products
• Fluvoxamine maleate3 products
• Midodrine hydrochloride3 products
• SitagliptinJanuvia, Zituvio, Brynovin · 3 products
• NilotinibTasigna, Danziten, Cavhanza · 3 products
• MirtazapineRemeronsoltab, Remeron · 3 products
• Risedronate3 products
• LevetiracetamKeppra, Spritam, Keppra XR · 3 products
• Vilazodone hydrochlorideViibryd · 3 products
• TofacitinibXeljanz, Xeljanz XR · 3 products
• Dabigatran etexilatePradaxa · 3 products
• Triamterene and hydrochlorothiazide2 products
• SelegilineEmsam, Zelapar · 2 products
• TicagrelorBrilinta · 2 products
• BupropionWellbutrin SR, Aplenzin, Wellbutrin XL · 2 products
• OfloxacinOcuflox · 2 products
• Abiraterone acetateZytiga, Abirtega, Yonsa · 2 products
• Zinc sulfate injection2 products
• Cilostazol2 products
• FenofibrateAntara, Lipofen, Tricor · 2 products
• Ondansetron2 products
• GlipizideGlucotrol XL · 2 products
• Desmopressin acetate (desmopressin acetate trihydrate)2 products
• LeflunomideArava · 2 products
• DapagliflozinFarxiga · 2 products
• Irinotecan hydrochlorideCamptosar, Onivyde · 2 products
• Deferoxamine mesylateDesferal · 2 products
• Azelastine hydrochloride2 products
• RegadenosonLexiscan · 2 products
• Palonosetron hydrochloridePosfrea · 2 products
• Imatinib mesylateGleevec, Imkeldi · 2 products
• ClopidogrelPlavix · 2 products
• Sitagliptin and metformin hydrochlorideZituvimet XR, Zituvimet, Janumet · 2 products
• TetrabenazineXenazine · 2 products
• AmbrisentanLetairis · 2 products
• Solifenacin succinate2 products
• PrucaloprideMotegrity · 2 products
• Ertapenem sodiumInvanz · 2 products
• Oxaliplatin2 products
• Brimonidine tartrateAlphagan P, Mirvaso · 2 products
• Ipratropium bromideAtrovent HFA · 2 products
• Mycophenolic acidMyfortic · 2 products
• CelecoxibCelebrex, Vyscoxa, Elyxyb - Celecoxib · 2 products
• Eribulin mesylateHalaven · 2 products
• PirfenidoneEsbriet · 2 products
• NintedanibOfev · 2 products
• AripiprazoleAbilify, Opipza, Abilify Asimtufii · 1 product
• BimatoprostLumigan, Latisse, Durysta · 1 product
• Brimonidine tartrate and timolol maleateCombigan · 1 product
• Olopatadine hydrochloride1 product
• FingolimodGilenya · 1 product
• MacitentanOpsumit · 1 product
• SirolimusHyftor, Fyarro · 1 product
• AzacitidineOnureg, Vidaza · 1 product
• Travoprost ophthalmic solutionTravatan Z, Idose Tr, Travoprost Ophthalmic Soluton · 1 product
• Azelastine hydrochloride and fluticasone propionateDymista · 1 product
• DoxycyclineDoxy 100, Acticlate Cap, Doryx Mpc · 1 product
• RivaroxabanXarelto · 1 product
• TigecyclineTygacil · 1 product
• CarboplatinKyxata · 1 product
• Ketorolac tromethamineAcuvail, Sprix, Ketrolac Tromethamine · 1 product
• Adefovir dipivoxil1 product
• PazopanibVotrient · 1 product
• Cisplatin1 product
• PentoxifyllineTrental · 1 product
• Desmopressin acetateDdavp, Stimate, Desmoda · 1 product
• Calcitonin salmonMiacalcin · 1 product
• TasimelteonHetlioz Lq, Hetlioz · 1 product
• HydrocortisoneSolu-Cortef, Proctozone-Hc, Alkindi Sprinkle · 1 product
• Fluticasone propionateFluticasone Propionate Diskus, Xhance, Flovent Diskus · 1 product
• CladribineMavenclad · 1 product
• BromfenacBromsite 0.075%, Prolensa · 1 product
• Balsalazide disodium1 product
• Alfuzosin hydrochlorideUroxatral · 1 product
• Bendamustine hydrochlorideTreanda, Vivimusta, Belrapzo · 1 product
• Melphalan HCLIvra, Evomela · 1 product
• DiclofenacZipsor, Lofena, Cambia · 1 product
• MoxifloxacinVigamox · 1 product
• Butorphanol tartrate1 product
• Mometasone furoate (mometasone)1 product
• BortezomibBoruzu, Velcade · 1 product
• Ibandronate sodium1 product
• Memantine hydrochloride1 product
• AtropineAtropen Auto-Injector, Isopto Atropine · 1 product
• Icosapent ethylVascepa · 1 product
• FidaxomicinDificid · 1 product
• Tranexamic acidCyklokapron · 1 product
• TeriparatideForteo, Bonsity · 1 product
• DaptomycinDapzura Rt · 1 product
• TrabectedinYondelis, Evdi · 1 product

• NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
• ANDA: Abbreviated New Drug Application: how a generic version is approved.

The sponsor is the company that holds the FDA application; it can differ from the labeler.

2026

1. September 23, 2026 · Class II · Ongoing · D-0877-2026 · Paroxetine

   Failed dissolution specifications.

   Paroxetine Extended-Release Tablets, 37.5mg, 30-count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326, NDC 60505-1318-3

2. August 13, 2026 · Class II · Ongoing · D-0804-2026 · Paroxetine

   Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria

   Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg, 30 count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326, NDC 60505-4379-3

3. April 8, 2026 · Class II · Ongoing · D-0510-2026 · Desmopressin acetate (desmopressin acetate trihydrate)

   Defective container: defect in a batch of bottle caps, specifically involving dislodged or missing cap liners.

   Desmopressin Nasal Spray, USP, 10 mcg/0.1 mL, 5 mL bottle (50 doses), Rx only, Mfg by: Apotek inc., Toronto, Ontario, Canada, M9L 1T9, Mfg for: Apotek Corp., Weston, FL 33326, NDC 60505-0815-0

4. March 5, 2026 · Class II · Ongoing · D-0407-2026 · Brimonidine tartrate and timolol maleate

   Lack of Assurance of Sterility

   Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%*, 5 mL, Rx Only, Sterile, Apotex Corp. Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0589-1.

2025

1. September 5, 2025 · Class II · Ongoing · D-0677-2025 · Ketorolac tromethamine

   Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns

   Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 5 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Richmond Hill, Ontario, Canada, L4C 5H2, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-1003-1.

2. September 5, 2025 · Class II · Ongoing · D-0676-2025 · Brimonidine tartrate and timolol maleate

   Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns

   Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, a) 5 mL and b) 10 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Richmond Hill, Ontario, Canada, L4C 5H2, Manufactured for: Apotex Corp., Weston,

3. May 28, 2025 · Class II · Ongoing · D-0495-2025 · Azelastine hydrochloride

   Lack of Assurance of Sterility

   Azelastine HCl Ophthalmic Solution, USP, 0.05%, 6 mL, Rx Only, Sterile, Mfg. by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9, Mfg. for: Apotex Corp., Weston, FL 33326, NDC 60505-0578-4

4. May 28, 2025 · Class II · Ongoing · D-0496-2025 · Brimonidine tartrate and timolol maleate

   Lack of Assurance of Sterility

   Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, 15 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0

5. May 28, 2025 · Class II · Ongoing · D-0494-2025 · Ketorolac tromethamine

   Lack of Assurance of Sterility

   Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 10 mL, Rx Only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-1003-2

2024

1. February 9, 2024 · Class II · Ongoing · D-0326-2024 · Fluticasone propionate

   CGMP Deviations: potential presence of Burkholderia cepacia complex

   Fluticasone Propionate Nasal Spray USP 50mcg, 120 Metered Sprays - 16 g net fill, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9, Manufactured for: Apotex Corp Weston, FL 33326. NDC 60505-0829-1

2023

1. November 1, 2023 · Class II · Ongoing · D-0119-2024 · Paroxetine

   Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine

   Paroxetine Hydrochloride Tablets USP, RX only, 10 mg a) 30-count bottle, NDC#: 60505-0097-1; b) 100-count bottle, NDC#: 60505-0097-2; c) 1000-count bottle, NDC#: 60505-0097-4, Manufactured by: Apotex Inc., Toronto, Ontar

2. November 1, 2023 · Class II · Ongoing · D-0120-2024 · Paroxetine

   Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine

   Paroxetine Hydrochloride Tablets USP, RX only, 20 mg, a) 100-count bottle, NDC#:60505-0083-2; b) 1000-count bottle, NDC#: 60505-0083-4 Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apo

3. November 1, 2023 · Class II · Ongoing · D-0122-2024 · Paroxetine

   Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine

   Paroxetine Hydrochloride Tablets USP, RX only, 40 mg, 1000-count bottle, NDC#:60505-0101-4 Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326.

4. November 1, 2023 · Class II · Ongoing · D-0121-2024 · Paroxetine

   Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine

   Paroxetine Hydrochloride Tablets USP, RX only, 30 mg, a)30-count bottle, NDC#: 60505-0084-1, b)100-count bottle, NDC#:60505-0084-2, c)1000-count bottle, NDC#: 60505-0084-4, Manufactured by: Apotex Inc., Toronto, Ontario,

5. April 26, 2023 · Class II · Completed · D-0568-2023 · Calcitonin salmon

   Presence of Foreign Substance: Glass splinter particle entrapped inside the pump ball seat rendered the pump inoperable.

   Calcitonin Salmon (synthetic origin) Nasal Spray, 2200 USP Calcitonin Salmon Units/mL, 200 USP Calcitonin Salmon Units/spray, 3.7 mL bottle, Rx only, Manufactured by: Apotex Corp., Toronto, Ontario, Canada, M9L 1T9, NDC

6. March 1, 2023 · Class II · Completed · D-0433-2023 · Brimonidine tartrate

   Lack of sterility assurance: Cracks have developed in some of the units caps of Brimonidine tartrate ophthalmic solution bottles. There is a possibility the broken cap may impact sterility.

   Brimonidine Tartrate Ophthalmic Solution 0.15%, Rx Only, Packaged as: a) 5 mL dropper bottle, NDC 60505-0564-1, UPC 3 60505 05641 5; b) 10 mL dropper bottle NDC 60505-0564-2, UPC 3 60505 05642 2; c) 15 mL dropper bottle,

2022

1. May 3, 2022 · Class III · Terminated · D-0881-2022 · Sirolimus

   Failed Dissolution Specifications: Sirolimus Oral Solution recalled due to lot RZ1598 exceeded the specification limit at the 14-month timepoint.

   Sirolimus Oral Solution, 1 mg/mL, 60 mL bottle, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326, NDC 60505-6197-2

2. January 26, 2022 · Class II · Terminated · D-0182-2024 · Fluticasone propionate

   CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

   Fluticasone Propionate Nasal Spray USP, 50MCG per spray, 16 g net fill weight, 120 Metered Sprays, For Intranasal Use Only, Rx Only, Manufactured for: Apotext Corp., Weston, FL 33326. NDC: 60505-0829-1

2021

1. March 31, 2021 · Class II · Ongoing · D-0324-2021 · Guanfacine

   Cross Contamination with Other Product: Product is being recalled due to Trace Amounts of Quetiapine Fumarate

   Guanfacine Extended-Release Tablets 2 mg,100-count bottles, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326, NDC 60505-3928-1, UPC 3 60505 39281

2. March 15, 2021 · Class II · Terminated · D-0427-2021 · Butorphanol tartrate

   CGMP Deviations: Intermittent exposure to temperature excursion during storage.

   Butorphanol Tartrate Nasal Solution USP 10 mg/mL 2. 5 mL bottles Rx Only NDC 60505-0813-1 Mfg by: Apotex Inc. Toronto, Ontario Canada M9L 1T9

3. March 15, 2021 · Class II · Terminated · D-0425-2021 · Travoprost ophthalmic solution

   CGMP Deviations: Intermittent exposure to temperature excursion during storage.

   TRAVOPROST OPHTHALMIC SOLUTION, USP 0.004% 2.5ML ; NDC/UPC 60505-0593-4; RX; DROPS

2019

1. October 22, 2019 · Class III · Terminated · D-0153-2020 · Atorvastatin

   Presence of Foreign Tablets/Capsules: a single tablet of Pravastatin 40 mg found in bottle of Atorvastatin Calcium 40 mg.

   Atorvastatin Calcium Tablets, USP 40 mg*, 1,000 count bottles, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326 NDC 60505-2580-8

2018

1. May 31, 2018 · Class II · Terminated · D-0841-2018 · Fluticasone propionate

   Presence of foreign substance: glass particles

   Fluticasone propionate Nasal Spray, USP, 50 mcg, packaged in 50 mcg per spray 120 Metered Sprays bottles, 16 g net fill weight, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apot

2017

1. February 3, 2017 · Class II · Terminated · D-0475-2017 · Cyclosporine

   Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown Impurities and Total Impurities.

   CycloSPORINE Capsules, USP, 100 mg, 30 count bottle, Rx Only, Manufactured by Apotex, Inc., Toronto, Ontario, Canada, Manufactured for Apotex Corp., Weston, FL --- NDC 60505-0134-0

2014

1. March 24, 2014 · Class II · Terminated · D-1577-2014 · Paroxetine

   Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.

   Paroxetine HCL Controlled-Release Tablets 37.5 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3675-3

2. March 24, 2014 · Class II · Terminated · D-1576-2014 · Paroxetine

   Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.

   Paroxetine HCL Controlled-Release Tablets 25 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3674-3

3. March 24, 2014 · Class II · Terminated · D-1574-2014 · Paroxetine

   Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.

   Paroxetine HCL Controlled-Release Tablets 12.5 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3673-3

2013

1. July 17, 2013 · Class II · Terminated · D-017-2014 · Acyclovir

   Presence of Particulate Matter: Product from lot KF2199, may contain tablets with pieces of nitrile rubber glove embedded within the tablets.

   Acyclovir Tablets USP 800 mg ,(NDC 60505-5307-1), Rx only, Manufactured by Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for Apotex Corp.,Weston, Florida 33326.

2011

1. June 15, 2011 · Class III · Terminated · D-1667-2012 · Azelastine hydrochloride

   CGMP Deviations: tubing used for filling may interact with the nasal formulation of this product.

   Azelastine HCl Nasal Solution, 0.1 %, 137 mcg/spray, 30 mL bottle (200 Metered Sprays), Rx only, Mfg by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, NDC 60505-0833-5.

2007

1. June 14, 2007 · Class II · Terminated · D-1661-2012 · Leflunomide

   Subpotent (Single Ingredient Drug): Distribution of product that did not meet specifications.

   Leflunomide tablets, 10 mg, a) 30-count bottle (NDC 60505-2502-1), b) 1000-count bottle (NDC 60505-2502-3), Rx only, Manufactured for Apotex Corp., Weston, Florida 33326 by Apotex Inc., Toronto, Ontario Canada M9L 1T9

2. June 14, 2007 · Class II · Terminated · D-1662-2012 · Leflunomide

   Subpotent (Single Ingredient Drug): Distribution of product that did not meet specifications.

   Leflunomide tablets, 20 mg, 1000-count bottle, Rx only, Manufactured for Apotex Corp., Weston, Florida 33326 by Apotex Inc., Toronto, Ontario Canada M9L 1T9, NDC 60505-2503-3

What do the recall classes mean?

Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).

1. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
2. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
3. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026

FDA Enforcement Report search → · Report an error →