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Apotex Corp. FDA Recalls
22 recalls on file across drugs, 2 of them Class I and 17 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg, 30 count bottle, Rx only, Manufactured by: Apotex Inc., Toronto,Class IIAug 13, 2026Failed Dissolution Specifications; product failed to meet 24 |
| Desmopressin Nasal Spray, USP, 10 mcg/0.1 mL, 5 mL bottle (50 doses), Rx only, Mfg by: Apotek inc., Toronto, Ontario, CaClass IIApr 8, 2026Defective container: defect in a batch of bottle caps, speci |
| Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%*, 5 mL, Rx Only, Sterile, Apotex Corp. Manufactured fClass IIMar 5, 2026Lack of Assurance of Sterility |
| Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 5 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Richmond Hill, OClass IISep 5, 2025Lack of Assurance of Sterility; atypical weight loss due to |
| Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, a) 5 mL and b) 10 mL, Rx Only, Sterile, ManufactureClass IISep 5, 2025Lack of Assurance of Sterility; atypical weight loss due to |
| Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, 15 mL, Rx Only, Sterile, Manufactured by: Apotex InClass IIMay 28, 2025Lack of Assurance of Sterility |
| Azelastine HCl Ophthalmic Solution, USP, 0.05%, 6 mL, Rx Only, Sterile, Mfg. by: Apotex Inc., Toronto, Ontario, Canada, Class IIMay 28, 2025Lack of Assurance of Sterility |
| Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 10 mL, Rx Only, Manufactured by: Apotex Inc., Toronto, Ontario, CanadaClass IIMay 28, 2025Lack of Assurance of Sterility |
| Lacosamide Oral Solution, USP, 10 mg/mL, 200 mL, Rx Only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9Class IIMay 28, 2025Defective Container: This recall is being initiated due to a |
| Fluticasone Propionate Nasal Spray USP 50mcg, 120 Metered Sprays - 16 g net fill, Rx Only, Manufactured by: Apotex IncClass IIFeb 9, 2024CGMP Deviations: potential presence of Burkholderia cepacia |
| Paroxetine Hydrochloride Tablets USP, RX only, 30 mg, a)30-count bottle, NDC#: 60505-0084-1, b)100-count bottle, NDC#:60Class IINov 1, 2023Failed Impurities/Degradation Specifications-Out of specific |
| Paroxetine Hydrochloride Tablets USP, RX only, 10 mg a) 30-count bottle, NDC#: 60505-0097-1; b) 100-count bottle, NDC#Class IINov 1, 2023Failed Impurities/Degradation Specifications-Out of specific |
| Paroxetine Hydrochloride Tablets USP, RX only, 40 mg, 1000-count bottle, NDC#:60505-0101-4 Manufactured by: Apotex Inc.,Class IINov 1, 2023Failed Impurities/Degradation Specifications-Out of specific |
| Paroxetine Hydrochloride Tablets USP, RX only, 20 mg, a) 100-count bottle, NDC#:60505-0083-2; b) 1000-count bottle, NDCClass IINov 1, 2023Failed Impurities/Degradation Specifications-Out of specific |
| Calcitonin Salmon (synthetic origin) Nasal Spray, 2200 USP Calcitonin Salmon Units/mL, 200 USP Calcitonin Salmon Units/sClass IIApr 26, 2023Presence of Foreign Substance: Glass splinter particle entra |
| Brimonidine Tartrate Ophthalmic Solution 0.15%, Rx Only, Packaged as: a) 5 mL dropper bottle, NDC 60505-0564-1, UPC 3 60Class IIMar 1, 2023Lack of sterility assurance: Cracks have developed in some o |
| Timolol Maleate Ophthalmic Solution, USP 0.5%, 2.5 mL, Rx Only, Mfg by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Mfg Class IIIDec 21, 2022Failed Stability Specifications: Out of specification for we |
| Aripiprazole Tablets, USP 20 mg, packaged in a) 1,000-count bottle (NDC 60505-2676-8, UPC 3 60505 26768 2), b) 30-countClass IIJul 7, 2022Failed dissolution specifications: OOS for dissolution at th |
| Sirolimus Oral Solution, 1 mg/mL, 60 mL bottle, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 MaClass IIIMay 3, 2022Failed Dissolution Specifications: Sirolimus Oral Solution r |
| Guanfacine Extended-Release Tablets 2 mg,100-count bottles, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario CanadClass IIMar 31, 2021Cross Contamination with Other Product: Product is being rec |
| Enoxaparin Sodium Injection, USP 100 mg/mL Single Dose Syringes with Automatic Safety Device For Subcutaneous Injection Class IFeb 2, 2021Labeling; Label Mixup; syringe barrels may containing markin |
| Enoxaparin Sodium Injection, USP 120 mg/ 0.8 mL Single Dose Syringes with Automatic Safety Device For Subcutaneous InjecClass IFeb 2, 2021Labeling; Label Mixup; syringe barrels may contain markings |