Apotex Corp.

FDA Regulatory Profile

Summary

Total Recalls
72 (6 Class I)
510(k) Clearances
0
Inspections
38
Compliance Actions
4

Recent Recalls

NumberClassProductDate
D-0676-2025Class IIBrimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, a) 5 mL and b) 10 mL, Rx Only, September 5, 2025
D-0677-2025Class IIKetorolac Tromethamine Ophthalmic Solution, 0.5%, 5 mL, Rx Only, Sterile, Manufactured by: Apotex InSeptember 5, 2025
D-0496-2025Class IIBrimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, 15 mL, Rx Only, Sterile, ManufaMay 28, 2025
D-0494-2025Class IIKetorolac Tromethamine Ophthalmic Solution, 0.5%, 10 mL, Rx Only, Manufactured by: Apotex Inc., ToroMay 28, 2025
D-0457-2025Class IILacosamide Oral Solution, USP, 10 mg/mL, 200 mL, Rx Only, Manufactured by: Apotex Inc., Toronto, OntMay 28, 2025
D-0495-2025Class IIAzelastine HCl Ophthalmic Solution, USP, 0.05%, 6 mL, Rx Only, Sterile, Mfg. by: Apotex Inc., TorontMay 28, 2025
D-0326-2024Class IIFluticasone Propionate Nasal Spray USP 50mcg, 120 Metered Sprays - 16 g net fill, Rx Only, ManufacFebruary 9, 2024
D-0119-2024Class IIParoxetine Hydrochloride Tablets USP, RX only, 10 mg a) 30-count bottle, NDC#: 60505-0097-1; b) 10November 1, 2023
D-0120-2024Class IIParoxetine Hydrochloride Tablets USP, RX only, 20 mg, a) 100-count bottle, NDC#:60505-0083-2; b) 10November 1, 2023
D-0122-2024Class IIParoxetine Hydrochloride Tablets USP, RX only, 40 mg, 1000-count bottle, NDC#:60505-0101-4 ManufactuNovember 1, 2023
D-0121-2024Class IIParoxetine Hydrochloride Tablets USP, RX only, 30 mg, a)30-count bottle, NDC#: 60505-0084-1, b)100-cNovember 1, 2023
D-0568-2023Class IICalcitonin Salmon (synthetic origin) Nasal Spray, 2200 USP Calcitonin Salmon Units/mL, 200 USP CalciApril 26, 2023
D-0433-2023Class IIBrimonidine Tartrate Ophthalmic Solution 0.15%, Rx Only, Packaged as: a) 5 mL dropper bottle, NDC 60March 1, 2023
D-0093-2023Class IIITimolol Maleate Ophthalmic Solution, USP 0.5%, 2.5 mL, Rx Only, Mfg by: Apotex Inc. Toronto, OntarioDecember 21, 2022
D-1285-2022Class IIAripiprazole Tablets, USP 20 mg, packaged in a) 1,000-count bottle (NDC 60505-2676-8, UPC 3 60505 2July 7, 2022
D-0881-2022Class IIISirolimus Oral Solution, 1 mg/mL, 60 mL bottle, Rx Only, Manufactured by: Apotex Inc. Toronto, OntarMay 3, 2022
D-0324-2021Class IIGuanfacine Extended-Release Tablets 2 mg,100-count bottles, Rx Only, Manufactured by: Apotex Inc. ToMarch 31, 2021
D-0262-2021Class IEnoxaparin Sodium Injection, USP 120 mg/ 0.8 mL Single Dose Syringes with Automatic Safety Device FoFebruary 2, 2021
D-0261-2021Class IEnoxaparin Sodium Injection, USP 100 mg/mL Single Dose Syringes with Automatic Safety Device For SubFebruary 2, 2021
D-0106-2021Class IIAripiprazole Tablets, USP 15 mg tablets, packaged in a) 1000 count bottle, NDC 60505-2675-8; b) 30 cNovember 11, 2020