Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
April 22, 2026DrugsFDA
Apotex Corp. recalls Desmopressin Nasal Spray, USP, 10 mcg/0.1 mL, 5 mL bottle (50 doses), Rx only, Mfg by: Apotek inc., Toronto, Ontario, Ca
Hazard: Defective container: defect in a batch of bottle caps, specifically involving dislodged or missing cap liners.
March 25, 2026DrugsFDA
Apotex Corp. recalls Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%*, 5 mL, Rx Only, Sterile, Apotex Corp. Manufactured f
Hazard: Lack of Assurance of Sterility
October 8, 2025DrugsFDA
Apotex Corp. recalls Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 5 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Richmond Hill, O
Hazard: Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
October 8, 2025DrugsFDA
Apotex Corp. recalls Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, a) 5 mL and b) 10 mL, Rx Only, Sterile, Manufacture
Hazard: Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
July 2, 2025DrugsFDA
Apotex Corp. recalls Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, 15 mL, Rx Only, Sterile, Manufactured by: Apotex In
Hazard: Lack of Assurance of Sterility
July 2, 2025DrugsFDA
Apotex Corp. recalls Azelastine HCl Ophthalmic Solution, USP, 0.05%, 6 mL, Rx Only, Sterile, Mfg. by: Apotex Inc., Toronto, Ontario, Canada,
Hazard: Lack of Assurance of Sterility
July 2, 2025DrugsFDA
Apotex Corp. recalls Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 10 mL, Rx Only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada
Hazard: Lack of Assurance of Sterility
June 11, 2025DrugsFDA
Apotex Corp. recalls Lacosamide Oral Solution, USP, 10 mg/mL, 200 mL, Rx Only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9
Hazard: Defective Container: This recall is being initiated due to a leaking unit stored horizontally.
February 28, 2024DrugsFDA
Apotex Corp. recalls Fluticasone Propionate Nasal Spray USP 50mcg, 120 Metered Sprays - 16 g net fill, Rx Only, Manufactured by: Apotex Inc
Hazard: CGMP Deviations: potential presence of Burkholderia cepacia complex
December 6, 2023DrugsFDA
Apotex Corp. recalls Paroxetine Hydrochloride Tablets USP, RX only, 40 mg, 1000-count bottle, NDC#:60505-0101-4 Manufactured by: Apotex Inc.,
Hazard: Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
December 6, 2023DrugsFDA
Apotex Corp. recalls Paroxetine Hydrochloride Tablets USP, RX only, 30 mg, a)30-count bottle, NDC#: 60505-0084-1, b)100-count bottle, NDC#:60
Hazard: Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
December 6, 2023DrugsFDA
Apotex Corp. recalls Paroxetine Hydrochloride Tablets USP, RX only, 20 mg, a) 100-count bottle, NDC#:60505-0083-2; b) 1000-count bottle, NDC
Hazard: Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
December 6, 2023DrugsFDA
Apotex Corp. recalls Paroxetine Hydrochloride Tablets USP, RX only, 10 mg a) 30-count bottle, NDC#: 60505-0097-1; b) 100-count bottle, NDC#
Hazard: Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
May 17, 2023DrugsFDA
Apotex Corp. recalls Calcitonin Salmon (synthetic origin) Nasal Spray, 2200 USP Calcitonin Salmon Units/mL, 200 USP Calcitonin Salmon Units/s
Hazard: Presence of Foreign Substance: Glass splinter particle entrapped inside the pump ball seat rendered the pump inoperable.
March 15, 2023DrugsFDA
Apotex Corp. recalls Brimonidine Tartrate Ophthalmic Solution 0.15%, Rx Only, Packaged as: a) 5 mL dropper bottle, NDC 60505-0564-1, UPC 3 60
Hazard: Lack of sterility assurance: Cracks have developed in some of the units caps of Brimonidine tartrate ophthalmic solution bottles. There is a possibility the broken cap may impact sterility.
January 4, 2023DrugsFDA
Apotex Corp. recalls Timolol Maleate Ophthalmic Solution, USP 0.5%, 2.5 mL, Rx Only, Mfg by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Mfg
Hazard: Failed Stability Specifications: Out of specification for weight loss at the 18-month stability timepoint and projected weight loss of 21.1% at shelf life.
July 27, 2022DrugsFDA
Apotex Corp. recalls Aripiprazole Tablets, USP 20 mg, packaged in a) 1,000-count bottle (NDC 60505-2676-8, UPC 3 60505 26768 2), b) 30-count
Hazard: Failed dissolution specifications: OOS for dissolution at the 12-month stability time point.
May 25, 2022DrugsFDA
Apotex Corp. recalls Sirolimus Oral Solution, 1 mg/mL, 60 mL bottle, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Ma
Hazard: Failed Dissolution Specifications: Sirolimus Oral Solution recalled due to lot RZ1598 exceeded the specification limit at the 14-month timepoint.
April 14, 2021DrugsFDA
Apotex Corp. recalls Guanfacine Extended-Release Tablets 2 mg,100-count bottles, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canad
Hazard: Cross Contamination with Other Product: Product is being recalled due to Trace Amounts of Quetiapine Fumarate
February 17, 2021DrugsFDA
Apotex Corp. recalls Enoxaparin Sodium Injection, USP 120 mg/ 0.8 mL Single Dose Syringes with Automatic Safety Device For Subcutaneous Injec
Hazard: Labeling; Label Mixup; syringe barrels may contain markings for 100 mg/mL (corresponding to 100 mg/mL strength) instead of 150 mg/mL (corresponding to 120 mg/0.8mL strength)
February 17, 2021DrugsFDA
Apotex Corp. recalls Enoxaparin Sodium Injection, USP 100 mg/mL Single Dose Syringes with Automatic Safety Device For Subcutaneous Injection
Hazard: Labeling; Label Mixup; syringe barrels may containing markings for 150 mg/mL (corresponding to 120 mg/0.8mL strength) instead of 100 mg/mL markings (corresponding to 100 mg/mL strength)
November 25, 2020DrugsFDA
Apotex Corp. recalls Aripiprazole Tablets, USP 15 mg tablets, packaged in a) 1000 count bottle, NDC 60505-2675-8; b) 30 count bottle, NDC 605
Hazard: Failed Dissolution Specifications: Out of specification for dissolution.
June 24, 2020DrugsFDA
Apotex Inc. recalls Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles, Rx Only Manufactured by: Apotex, Inc. T
Hazard: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above acceptable intake levels
November 20, 2019DrugsFDA
Apotex Inc. recalls Rite Aid Pharmacy Maximum Strength Ranitidine Tablets, USP 150 mg-acid reducer Distributed By: Rite Aid 30 Hunter Lane C
Hazard: GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
November 20, 2019DrugsFDA
Apotex Inc. recalls Equate Maximum Strength Ranitidine Tablets, USP 150 mg Acid Reducer Cool Mint Tablets Sugar Free 65 Tablets NDC: 49035-1
Hazard: GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
November 20, 2019DrugsFDA
Apotex Inc. recalls Rite Aid Pharmacy Maximum Strength Ranitidine Tablets, USP 150 mg Cool Mint Acid Reducer 24 Tablets Sugar Free NDC 11822
Hazard: GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
November 20, 2019DrugsFDA
Apotex Inc. recalls Equate Maximum Strength Ranitidine Tablets, USP 150 mg Acid Reducer 130 Tablets Distributed by Wal-Mart Stores, Inc. Ben
Hazard: GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
November 20, 2019DrugsFDA
Apotex Inc. recalls Walgreens Regular Strength Wal-Zan 75 Ranitidine Tablets, USP 75 mg/Acid Reducer 30 Tablets NDC 0363-1029-03 Distributed
Hazard: GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
November 20, 2019DrugsFDA
Apotex Inc. recalls Walgreens Maximum Strength Wal-Zan 150 Ranitidine Tablets, USP 150 mg/Acid Reducer Distributed By: Walgreen Co., 200 Wil
Hazard: GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
November 6, 2019DrugsFDA
Apotex Inc. recalls Atorvastatin Calcium Tablets, USP 40 mg*, 1,000 count bottles, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Ca
Hazard: Presence of Foreign Tablets/Capsules: a single tablet of Pravastatin 40 mg found in bottle of Atorvastatin Calcium 40 mg.