Apotex Corp.: 33 recalls on record

Recalls filed with 1 agency: FDA (33).

First recall on record: August 15, 2012. Most recent: September 2, 2026.

Risk classification: Class I: 4 · Class II: 24 · Class III: 5

Most recent recalls

DateAgencyProduct
September 2, 2026FDAPaxil CR, Paroxetine, Extended-Release Tablets, 37.5mg, 30 count bottle, Rx only, Manufac…D-0804-2026
April 22, 2026FDADesmopressin Nasal Spray, USP, 10 mcg/0.1 mL, 5 mL bottle (50 doses), Rx only, Mfg by: Ap…D-0510-2026
March 25, 2026FDABrimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%*, 5 mL, Rx Only, Steri…D-0407-2026
October 8, 2025FDAKetorolac Tromethamine Ophthalmic Solution, 0.5%, 5 mL, Rx Only, Sterile, Manufactured by…D-0677-2025
October 8, 2025FDABrimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, a) 5 mL and b) 10 mL…D-0676-2025
July 2, 2025FDAKetorolac Tromethamine Ophthalmic Solution, 0.5%, 10 mL, Rx Only, Manufactured by: Apotex…D-0494-2025
July 2, 2025FDABrimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, 15 mL, Rx Only, Ster…D-0496-2025
July 2, 2025FDAAzelastine HCl Ophthalmic Solution, USP, 0.05%, 6 mL, Rx Only, Sterile, Mfg. by: Apotex I…D-0495-2025
June 11, 2025FDALacosamide Oral Solution, USP, 10 mg/mL, 200 mL, Rx Only, Manufactured by: Apotex Inc., T…D-0457-2025
February 28, 2024FDAFluticasone Propionate Nasal Spray USP 50mcg, 120 Metered Sprays - 16 g net fill, Rx Onl…D-0326-2024
December 6, 2023FDAParoxetine Hydrochloride Tablets USP, RX only, 30 mg, a)30-count bottle, NDC#: 60505-0084…D-0121-2024
December 6, 2023FDAParoxetine Hydrochloride Tablets USP, RX only, 10 mg a) 30-count bottle, NDC#: 60505-00…D-0119-2024
December 6, 2023FDAParoxetine Hydrochloride Tablets USP, RX only, 40 mg, 1000-count bottle, NDC#:60505-0101-…D-0122-2024
December 6, 2023FDAParoxetine Hydrochloride Tablets USP, RX only, 20 mg, a) 100-count bottle, NDC#:60505-008…D-0120-2024
May 17, 2023FDACalcitonin Salmon (synthetic origin) Nasal Spray, 2200 USP Calcitonin Salmon Units/mL, 20…D-0568-2023
March 15, 2023FDABrimonidine Tartrate Ophthalmic Solution 0.15%, Rx Only, Packaged as: a) 5 mL dropper bot…D-0433-2023
January 4, 2023FDATimolol Maleate Ophthalmic Solution, USP 0.5%, 2.5 mL, Rx Only, Mfg by: Apotex Inc. Toron…D-0093-2023
July 27, 2022FDAAripiprazole Tablets, USP 20 mg, packaged in a) 1,000-count bottle (NDC 60505-2676-8, UP…D-1285-2022
May 25, 2022FDASirolimus Oral Solution, 1 mg/mL, 60 mL bottle, Rx Only, Manufactured by: Apotex Inc. Tor…D-0881-2022
April 14, 2021FDAGuanfacine Extended-Release Tablets 2 mg,100-count bottles, Rx Only, Manufactured by: Apo…D-0324-2021
February 17, 2021FDAEnoxaparin Sodium Injection, USP 100 mg/mL Single Dose Syringes with Automatic Safety Dev…D-0261-2021
February 17, 2021FDAEnoxaparin Sodium Injection, USP 120 mg/ 0.8 mL Single Dose Syringes with Automatic Safet…D-0262-2021
November 25, 2020FDAAripiprazole Tablets, USP 15 mg tablets, packaged in a) 1000 count bottle, NDC 60505-2675…D-0106-2021
January 11, 2017FDATorsemide Tablets, 5 mg 100-count bottle, Rx only ,Manufactured by: Apotex Inc., Toronto,…D-0245-2017
January 11, 2017FDATorsemide Tablets, 20 mg 100-count bottle, Rx only, Manufactured by: Apotex Inc., Toronto…D-0244-2017

Questions about this company

How many recalls does Apotex Corp. have?
Recalert has 33 U.S. recalls on record for Apotex Corp., published between August 15, 2012 and September 2, 2026.
What was the most recent Apotex Corp. recall?
FDA recall D-0804-2026, published September 2, 2026: 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…
Which agencies have handled Apotex Corp. recalls?
Apotex Corp. appears as the recalling firm in recalls from: FDA (33).

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