Apotex recalls

Apotex has 76 recalls on record with the FDA and USDA, the earliest in 2012 and the latest reported on 7 Oct 2026. 18 are still ongoing. 4 were reported in the last 12 months. The most frequent reason is potency & assay.

Total recalls76since 2012

Last 12 months4reported

Class I68% of total

Ongoing18latest 7 Oct 2026

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 0May 1 3 0Aug 0 2 0Nov 0 0 0Feb 1 1 0May 0 0 0Aug 1 1

Severity split

Class I 6 8%Class II 53 70%Class III 17 22%

Why apotex is recalled

Product types

Brands

By year

202645%
202568%
202411%
202379%
202223%
202134%
202023%
2019811%
201834%
201745%

Ongoing apotex recalls

18 active

Reported	Class	Recall	Company	Reason	Where
7 Oct 2026Drug	CLASS II	Paroxetine Extended-Release Tablets, 37.5mg recalled by ApotexParoxetine Hydrochloride	Apotex	Potency & Assay	Nationwide
2 Sep 2026Drug	CLASS II	Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg recalled	Apotex	Potency & Assay	Nationwide
22 Apr 2026Drug	CLASS II	Desmopressin Nasal Spray, USP, 10 mcg/ bottle (50 doses) recalled	Apotex	Other	Nationwide
25 Mar 2026Drug	CLASS II	Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%* recalledBrimonidine Tartrate/timolol Maleate Ophthalmic Solution	Apotex	Sterility	Nationwide
8 Oct 2025Drug	CLASS II	Ketorolac Tromethamine Ophthalmic Solution recalled by ApotexKetorolac Tromethamine	Apotex	Sterility	Nationwide
8 Oct 2025Drug	CLASS II	Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution recalledBrimonidine Tartrate/timolol Maleate Ophthalmic Solution	Apotex	Sterility	Nationwide

All apotex recalls, newest first

76 total

Reported	Class	Recall	Company	Reason	Where
7 Oct 2026Drug	CLASS II	Paroxetine Extended-Release Tablets, 37.5mg recalled by ApotexParoxetine Hydrochloride	Apotex	Potency & Assay	Nationwide
2 Sep 2026Drug	CLASS II	Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg recalled	Apotex	Potency & Assay	Nationwide
22 Apr 2026Drug	CLASS II	Desmopressin Nasal Spray, USP, 10 mcg/ bottle (50 doses) recalled	Apotex	Other	Nationwide
25 Mar 2026Drug	CLASS II	Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%* recalledBrimonidine Tartrate/timolol Maleate Ophthalmic Solution	Apotex	Sterility	Nationwide
8 Oct 2025Drug	CLASS II	Ketorolac Tromethamine Ophthalmic Solution recalled by ApotexKetorolac Tromethamine	Apotex	Sterility	Nationwide
8 Oct 2025Drug	CLASS II	Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution recalledBrimonidine Tartrate/timolol Maleate Ophthalmic Solution	Apotex	Sterility	Nationwide
2 Jul 2025Drug	CLASS II	Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5% recalledBrimonidine Tartrate/timolol Maleate Ophthalmic Solution	Apotex	Sterility	Nationwide
2 Jul 2025Drug	CLASS II	Azelastine HCl Ophthalmic Solution recalled by ApotexAzelastine Hydrochloride	Apotex	Sterility	Nationwide
2 Jul 2025Drug	CLASS II	Ketorolac Tromethamine Ophthalmic Solution recalled by ApotexKetorolac Tromethamine	Apotex	Sterility	Nationwide
11 Jun 2025Drug	CLASS II	Lacosamide Oral Solution, USP, 10 mg/mL recalled by Apotex	Apotex	Packaging Defects	Nationwide
28 Feb 2024Drug	CLASS II	Fluticasone Propionate Nasal Spray USP 50mcg recalled by Apotex	Apotex	Sterility	Nationwide
6 Dec 2023Drug	CLASS II	Paroxetine Hydrochloride Tablets recalled by Apotex	Apotex	Potency & Assay	Nationwide
6 Dec 2023Drug	CLASS II	Paroxetine Hydrochloride Tablets recalled by Apotex	Apotex	Potency & Assay	Nationwide
6 Dec 2023Drug	CLASS II	Paroxetine Hydrochloride Tablets recalled by Apotex	Apotex	Potency & Assay	Nationwide
6 Dec 2023Drug	CLASS II	Paroxetine Hydrochloride Tablets recalled by Apotex	Apotex	Potency & Assay	Nationwide
17 May 2023Drug	CLASS II	Calcitonin Salmon (synthetic origin) Nasal Spray recalled by ApotexCalcitonin Salmon	Apotex	Foreign Material	Nationwide
15 Mar 2023Drug	CLASS II	Brimonidine Tartrate Ophthalmic Solution recalled by Apotex	Apotex	Sterility	Nationwide
4 Jan 2023Drug	CLASS III	Timolol Maleate Ophthalmic Solution recalled by Apotex	Apotex	Potency & Assay	Nationwide
27 Jul 2022Drug	CLASS II	Aripiprazole Tablets, USP 20 mg recalled by Apotex	Apotex	Potency & Assay	Nationwide
25 May 2022Drug	CLASS III	Sirolimus Oral Solution, 1 mg/mL recalled by Apotex	Apotex	Potency & Assay	Nationwide
14 Apr 2021Drug	CLASS II	Guanfacine Extended-Release Tablets 2 mg recalled by ApotexGuanfacine Extended-release	Apotex	Other	Nationwide
17 Feb 2021Drug	CLASS I	Enoxaparin Sodium Injection recalled by Apotex	Apotex	Packaging Defects	Nationwide
17 Feb 2021Drug	CLASS I	Enoxaparin Sodium Injection recalled by Apotex	Apotex	Packaging Defects	Nationwide
25 Nov 2020Drug	CLASS II	Aripiprazole Tablets recalled by Apotex	Apotex	Potency & Assay	Nationwide
24 Jun 2020Drug	CLASS II	Metformin Hydrochloride Extended-Release Tablets, USP 500 mg recalled	Apotex	Nitrosamine Impurity	Nationwide
20 Nov 2019Drug	CLASS II	Walgreens Maximum Strength Wal-Zan, USP 150 mg/Acid Reducer recalled	Apotex	Nitrosamine Impurity	Nationwide
20 Nov 2019Drug	CLASS II	Walgreens Regular Strength Wal-Zan, USP 75 mg/Acid Reducer recalled	Apotex	Nitrosamine Impurity	Nationwide
20 Nov 2019Drug	CLASS II	Rite Aid Pharmacy Maximum Strength Ranitidine Tablets recalled by Apotex	Apotex	Nitrosamine Impurity	Nationwide
20 Nov 2019Drug	CLASS II	Rite Aid Pharmacy Maximum Strength Ranitidine Tablets recalled by Apotex	Apotex	Nitrosamine Impurity	Nationwide
20 Nov 2019Drug	CLASS II	Equate Maximum Strength Ranitidine Tablets recalled by Apotex	Apotex	Nitrosamine Impurity	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.