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.
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