Apotex Corp.

Complete recall history across all FDA and CPSC categories — 31 total recalls

Apotex Corp. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Drug Recalls (31)

FDA drug safety enforcement actions by Apotex Corp.

Date Product Reason Class
Apr 8, 2026 Desmopressin Nasal Spray, USP, 10 mcg/0.1 mL, 5 mL bottle (50 doses), Rx only... Defective container: defect in a batch of bottle caps, specifically involving... Class II
Mar 5, 2026 Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%*, 5 mL, Rx... Lack of Assurance of Sterility Class II
Sep 5, 2025 Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 5 mL, Rx Only, Sterile, Man... Lack of Assurance of Sterility; atypical weight loss due to improper bottle s... Class II
Sep 5, 2025 Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, a) 5 mL ... Lack of Assurance of Sterility; atypical weight loss due to improper bottle s... Class II
May 28, 2025 Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, 15 mL, R... Lack of Assurance of Sterility Class II
May 28, 2025 Lacosamide Oral Solution, USP, 10 mg/mL, 200 mL, Rx Only, Manufactured by: Ap... Defective Container: This recall is being initiated due to a leaking unit sto... Class II
May 28, 2025 Azelastine HCl Ophthalmic Solution, USP, 0.05%, 6 mL, Rx Only, Sterile, Mfg. ... Lack of Assurance of Sterility Class II
May 28, 2025 Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 10 mL, Rx Only, Manufacture... Lack of Assurance of Sterility Class II
Feb 9, 2024 Fluticasone Propionate Nasal Spray USP 50mcg, 120 Metered Sprays - 16 g net ... CGMP Deviations: potential presence of Burkholderia cepacia complex Class II
Nov 1, 2023 Paroxetine Hydrochloride Tablets USP, RX only, 40 mg, 1000-count bottle, NDC#... Failed Impurities/Degradation Specifications-Out of specification (OOS) resul... Class II
Nov 1, 2023 Paroxetine Hydrochloride Tablets USP, RX only, 20 mg, a) 100-count bottle, ND... Failed Impurities/Degradation Specifications-Out of specification (OOS) resul... Class II
Nov 1, 2023 Paroxetine Hydrochloride Tablets USP, RX only, 10 mg a) 30-count bottle, ND... Failed Impurities/Degradation Specifications-Out of specification (OOS) resul... Class II
Nov 1, 2023 Paroxetine Hydrochloride Tablets USP, RX only, 30 mg, a)30-count bottle, NDC#... Failed Impurities/Degradation Specifications-Out of specification (OOS) resul... Class II
Apr 26, 2023 Calcitonin Salmon (synthetic origin) Nasal Spray, 2200 USP Calcitonin Salmon ... Presence of Foreign Substance: Glass splinter particle entrapped inside the p... Class II
Mar 1, 2023 Brimonidine Tartrate Ophthalmic Solution 0.15%, Rx Only, Packaged as: a) 5 mL... Lack of sterility assurance: Cracks have developed in some of the units caps ... Class II
Dec 21, 2022 Timolol Maleate Ophthalmic Solution, USP 0.5%, 2.5 mL, Rx Only, Mfg by: Apote... Failed Stability Specifications: Out of specification for weight loss at the ... Class III
Jul 7, 2022 Aripiprazole Tablets, USP 20 mg, packaged in a) 1,000-count bottle (NDC 6050... Failed dissolution specifications: OOS for dissolution at the 12-month stabil... Class II
May 3, 2022 Sirolimus Oral Solution, 1 mg/mL, 60 mL bottle, Rx Only, Manufactured by: Apo... Failed Dissolution Specifications: Sirolimus Oral Solution recalled due to lo... Class III
Mar 31, 2021 Guanfacine Extended-Release Tablets 2 mg,100-count bottles, Rx Only, Manufact... Cross Contamination with Other Product: Product is being recalled due to Trac... Class II
Feb 2, 2021 Enoxaparin Sodium Injection, USP 120 mg/ 0.8 mL Single Dose Syringes with Aut... Labeling; Label Mixup; syringe barrels may contain markings for 100 mg/mL (co... Class I
Feb 2, 2021 Enoxaparin Sodium Injection, USP 100 mg/mL Single Dose Syringes with Automati... Labeling; Label Mixup; syringe barrels may containing markings for 150 mg/mL ... Class I
Nov 11, 2020 Aripiprazole Tablets, USP 15 mg tablets, packaged in a) 1000 count bottle, ND... Failed Dissolution Specifications: Out of specification for dissolution. Class II
Dec 14, 2016 Torsemide Tablets, 20 mg 100-count bottle, Rx only, Manufactured by: Apotex I... CGMP Deviations Class II
Dec 14, 2016 Torsemide Tablets, 5 mg 100-count bottle, Rx only ,Manufactured by: Apotex In... CGMP Deviations Class II
Aug 21, 2014 Candesartan Cilexetil and Hydrochlorothiazide Tablets 32 mg/12.5 mg, 90 count... Failed Impurity/Degradation Specification; high out of specification for CAD ... Class III
Apr 18, 2014 Olanzapine Orally Disintegrating Tablets 5 mg, 30-count Bottle, Rx only, Manu... Subpotent Drug: Out of specification (OOS) results at the 9 month temperature... Class III
May 10, 2013 Piperacillin and Tazobactam for Injection, USP, 40.5 grams per Pharmacy Bulk ... Crystallization: Potential to exhibit precipitation/crystallization in IV bag... Class I
Mar 18, 2013 Piperacillin and Tazobactam for Injection, USP, 40.5 grams per Pharmacy Bulk ... Crystallization: Potential to exhibit precipitation/crystallization in IV bag... Class I
Apr 5, 2012 Meloxicam Tablets, USP, 15 mg, Rx Only, 100 Tablets per Bottle, Manufactured ... Tablet Thickness: Recall was initiated due to the presence of one slightly ov... Class II
Jun 15, 2011 Azelastine HCl Nasal Solution, 0.1 %, 137 mcg/spray, 30 mL bottle (200 Metere... CGMP Deviations: tubing used for filling may interact with the nasal formulat... Class III
Jun 14, 2007 Leflunomide tablets, 20 mg, 1000-count bottle, Rx only, Manufactured for Apot... Subpotent (Single Ingredient Drug): Distribution of product that did not meet... Class II
Jun 14, 2007 Leflunomide tablets, 10 mg, a) 30-count bottle (NDC 60505-2502-1), b) 1000-co... Subpotent (Single Ingredient Drug): Distribution of product that did not meet... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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