Apotex Inc.: Recalls

76 recall records from Jun 14, 2007 to Sep 23, 2026, newest first. Showing 1 to 76.

What this list covers: FDA records filed under the name "Apotex Inc." and its spelling variant "Apotex".

Back to the Apotex Inc. profile

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-0677-2025Class IIKetorolac Tromethamine Ophthalmic Solution, 0.5%, 5 mL, Rx Only, Sterile, Manufactured by: Apotex…Sep 5, 2025
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-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-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-0326-2024Class IIFluticasone Propionate Nasal Spray USP 50mcg, 120 Metered Sprays - 16 g net fill, Rx Only…Feb 9, 2024
D-0122-2024Class IIParoxetine Hydrochloride Tablets USP, RX only, 40 mg, 1000-count bottle, NDC#:60505-0101-4…Nov 1, 2023
D-0121-2024Class IIParoxetine Hydrochloride Tablets USP, RX only, 30 mg, a)30-count bottle, NDC#: 60505-0084-1…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-0119-2024Class IIParoxetine Hydrochloride Tablets USP, RX only, 10 mg a) 30-count bottle, NDC#: 60505-0097-1; 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
D-0324-2021Class IIGuanfacine Extended-Release Tablets 2 mg,100-count bottles, Rx Only, Manufactured by: Apotex Inc…Mar 31, 2021
D-0262-2021Class IEnoxaparin Sodium Injection, USP 120 mg/ 0.8 mL Single Dose Syringes with Automatic Safety Device…Feb 2, 2021
D-0261-2021Class IEnoxaparin Sodium Injection, USP 100 mg/mL Single Dose Syringes with Automatic Safety Device For…Feb 2, 2021
D-0106-2021Class IIAripiprazole Tablets, USP 15 mg tablets, packaged in a) 1000 count bottle, NDC 60505-2675-8; b) 30…Nov 11, 2020
D-1303-2020Class IIMetformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles, Rx Only…May 27, 2020
D-0153-2020Class IIIAtorvastatin Calcium Tablets, USP 40 mg*, 1,000 count bottles, Rx Only, Manufactured by: Apotex Inc…Oct 22, 2019
D-0319-2020Class IIRite Aid Pharmacy Maximum Strength Ranitidine Tablets, USP 150 mg-acid reducer Distributed By: Rite…Sep 24, 2019
D-0318-2020Class IIEquate Maximum Strength Ranitidine Tablets, USP 150 mg Acid Reducer Cool Mint Tablets Sugar Free 65…Sep 24, 2019
D-0317-2020Class IIRite Aid Pharmacy Maximum Strength Ranitidine Tablets, USP 150 mg Cool Mint Acid Reducer 24 Tablets…Sep 24, 2019
D-0316-2020Class IIEquate Maximum Strength Ranitidine Tablets, USP 150 mg Acid Reducer 130 Tablets Distributed by…Sep 24, 2019
D-0315-2020Class IIWalgreens Regular Strength Wal-Zan 75 Ranitidine Tablets, USP 75 mg/Acid Reducer 30 Tablets NDC…Sep 24, 2019
D-0314-2020Class IIWalgreens Maximum Strength Wal-Zan 150 Ranitidine Tablets, USP 150 mg/Acid Reducer Distributed By…Sep 24, 2019
D-0992-2019Class IIDrospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.03 mg, 28 Tablets Blister, 1 Unit (NDC…Mar 1, 2019
D-0841-2018Class IIFluticasone propionate Nasal Spray, USP, 50 mcg, packaged in 50 mcg per spray 120 Metered Sprays…May 31, 2018
D-0840-2018Class IPiperacillin and Tazobactam for Injection, USP 4.5 gram/vial* 10-count Single Use Vials per carton…May 8, 2018
D-0839-2018Class IPiperacillin and Tazobactam for Injection, USP 3.375 gram/vial* 10-count Single Use Vials per…May 8, 2018
D-0475-2017Class IICycloSPORINE Capsules, USP, 100 mg, 30 count bottle, Rx Only, Manufactured by Apotex, Inc., Toronto…Feb 3, 2017
D-0471-2017Class IIIAripiprazole Tablets, 2 mg, 30-count bottle, Rx only, Manufactured by: Apotex Inc., Toronto…Dec 19, 2016
D-0245-2017Class IITorsemide Tablets, 5 mg 100-count bottle, Rx only ,Manufactured by: Apotex Inc., Toronto, Ontario…Dec 14, 2016
D-0244-2017Class IITorsemide Tablets, 20 mg 100-count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario…Dec 14, 2016
D-0009-2016Class IIBromfenac Ophthalmic Solution 0.09%, packaged in a) 1.7 mL bottle (NDC 60505-0595-05), b) 2.5 mL…Aug 25, 2015
D-1814-2015Class IICevimeline Hydrochloride Capsules, 30 mg a) 100 count bottle, and b) 500 count bottle, Rx Only…Aug 17, 2015
D1834-2015Class IIIVerapamil Hydrochloride Extended-Release tablets, USP, 240 mg, 500-count bottles, Rx Only, Apotex…Jul 21, 2015
D-1215-2015Class IIEnalapril maleate and hydrochlorothiazide tablets USP, 10/25 mg, 100-count bottle, Rx only…May 29, 2015
D-1214-2015Class IILosartan potassium tablets USP, 50 mg, 90-count bottle, Rx only, Manufactured for Apotex Inc 150…May 29, 2015
D-1213-2015Class IILosartan potassium tablets USP, 100 mg, 90-count bottle, Rx only, Manufactured for Apotex Inc 150…May 29, 2015
D-1212-2015Class IILosartan potassium tablets USP, 25 mg, 90- count bottle, Rx only, Manufactured for Apotex Inc 150…May 29, 2015
D-1081-2015Class IIIOlanzapine, Orally Disintegrating Tablets, 20 mg, 30-count bottle, Rx only, Manufactured by Apotex…Apr 7, 2015
D-1080-2015Class IIIOlanzapine, Orally Disintegrating Tablets, 10 mg, a) 30-count bottle (NDC 60505-3276-03), b)…Apr 7, 2015
D-1079-2015Class IIIOlanzapine, Orally Disintegrating Tablets, 5 mg, a) 30-count bottle (NDC 60505-3275-03), b)…Apr 7, 2015
D-0487-2015Class IIIBromfenac Ophthalmic Solution 0.09%, Rx Only. Mfg For: Apotex Corp., Weston, FL, 33326. Available…Feb 12, 2015
D-0244-2015Class IIICandesartan Cilexetil Tablets, 32 mg, a) 30-count bottle (NDC 60505-3621-3) b) 90-count bottles (NDC…Oct 16, 2014
D-0243-2015Class IIICandesartan Cilexetil Tablets, 16 mg, a) 30-count bottle (NDC 60505-3620-3) b) 90-count bottles (NDC…Oct 16, 2014
D-0242-2015Class IIICandesartan Cilexetil Tablets, 8 mg, 30-count bottle, Rx Only, Manufactured by Apotex Research Pvt…Oct 16, 2014
D-0241-2015Class IIICandesartan Cilexetil Tablets, 4 mg, 30-count bottle, Rx Only, Manufactured by Apotex Research Pvt…Oct 16, 2014
D-1570-2014Class IIICandesartan Cilexetil and Hydrochlorothiazide Tablets 32 mg/12.5 mg, 90 count bottles, Rx only…Aug 21, 2014
D-1609-2014Class IIIOlanzapine Orally Disintegrating Tablets 5 mg, 30-count Bottle, Rx only, Manufactured by Apotex Inc…Apr 18, 2014
D-1582-2014Class IIPAXIL (Paroxetine HCL) Tablets 40 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline…Mar 24, 2014
D-1581-2014Class IIPAXIL (Paroxetine HCL) Tablets 20 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline…Mar 24, 2014
D-1580-2014Class IIPAXIL (Paroxetine HCL) Tablets 10 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline…Mar 24, 2014
D-1579-2014Class IIPAXIL CR (Paroxetine HCL) Controlled-Release Tablets 37.5 mg, 30-count bottle, Rx only, Manufactured…Mar 24, 2014
D-1578-2014Class IIPAXIL CR (Paroxetine HCL) Controlled-Release Tablets 25 mg, 30-count bottle, Rx only, Manufactured…Mar 24, 2014
D-1577-2014Class IIParoxetine HCL Controlled-Release Tablets 37.5 mg, 30-count bottle, Rx only, Manufactured by…Mar 24, 2014
D-1576-2014Class IIParoxetine HCL Controlled-Release Tablets 25 mg, 30-count bottle, Rx only, Manufactured by…Mar 24, 2014
D-1575-2014Class IIPAXIL (Paroxetine HCL) Oral Suspension 10 mg/5 mL - 250 mL bottle, Rx Only, Manufactured by…Mar 24, 2014
D-1574-2014Class IIParoxetine HCL Controlled-Release Tablets 12.5 mg, 30-count bottle, Rx only, Manufactured by…Mar 24, 2014
D-1299-2014Class IIIRisperidone Oral Solution, 1 mg/mL, 30 mL bottle, Rx only, Manufactured by Apotex Inc., Toronto…Mar 20, 2014
D-017-2014Class IIAcyclovir Tablets USP 800 mg ,(NDC 60505-5307-1), Rx only, Manufactured by Apotex Inc., Toronto…Jul 17, 2013
D-852-2013Class IILatanoprost Ophthalmic Solution, 0.005% (125 mcg/2.5 mL), 2.5 mL bottle, Rx only, Manufactured by…Jun 25, 2013
D-835-2013Class IPiperacillin and Tazobactam for Injection, USP, 40.5 grams per Pharmacy Bulk Package vial, Rx only…May 10, 2013
D-806-2013Class IPiperacillin and Tazobactam for Injection, USP, 40.5 grams per Pharmacy Bulk Package vial, Rx only…Mar 18, 2013
D-1439-2012Class IIDorzolamide HCI/Timolol Maleate Ophthalmic Solution 22.3mg/6.8mg per mL, 10mL bottle, For Topical…Apr 30, 2012
D-1443-2012Class IIMeloxicam Tablets, USP, 15 mg, Rx Only, 100 Tablets per Bottle, Manufactured by: Strides Acrolab…Apr 5, 2012
D-1667-2012Class IIIAzelastine HCl Nasal Solution, 0.1 %, 137 mcg/spray, 30 mL bottle (200 Metered Sprays), Rx only, Mfg…Jun 15, 2011
D-1662-2012Class IILeflunomide tablets, 20 mg, 1000-count bottle, Rx only, Manufactured for Apotex Corp., Weston…Jun 14, 2007
D-1661-2012Class IILeflunomide tablets, 10 mg, a) 30-count bottle (NDC 60505-2502-1), b) 1000-count bottle (NDC…Jun 14, 2007

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