--- title: "Apotex Corp. Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Apotex Corp. recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/apotex-corp/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Apotex Corp. recall records **14** reported ongoing 19 records in this archive. Latest source date Aug 13, 2026. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Aug 13, 2026 FDA drug enforcement ### [Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg, 30 count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp.,...](https://isitonrecall.com/recall/fda-drug-d-0804-2026-paxil-cr-paroxetine-extended-release-tablets-37-5mg-30-count-bottle-rx-only-manufactured-by-apotex-i/) Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria Class II Reported ongoing Distribution: US Nationwide. [Official source for Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg, 30 count bottle, Rx only, Manufactured by...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0804-2026%22) Apr 8, 2026 FDA drug enforcement ### [Desmopressin Nasal Spray, USP, 10 mcg/0.1 mL, 5 mL bottle (50 doses), Rx only, Mfg by: Apotek inc., Toronto, Ontario, Canada, M9L 1T9, Mfg for: Apotek Corp., Weston, FL 33326, N...](https://isitonrecall.com/recall/fda-drug-d-0510-2026-desmopressin-nasal-spray-usp-10-mcg-0-1-ml-5-ml-bottle-50-doses-rx-only-mfg-by-apotek-inc-toronto-on/) Defective container: defect in a batch of bottle caps, specifically involving dislodged or missing cap liners. Class II Reported ongoing Distribution: U.S.A. Nationwide [Official source for Desmopressin Nasal Spray, USP, 10 mcg/0.1 mL, 5 mL bottle (50 doses), Rx only, Mfg by: Apotek inc...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0510-2026%22) Mar 5, 2026 FDA drug enforcement ### [Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%\*, 5 mL, Rx Only, Sterile, Apotex Corp. Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0589-1.](https://isitonrecall.com/recall/fda-drug-d-0407-2026-brimonidine-tartrate-timolol-maleate-ophthalmic-solution-0-2-0-5-5-ml-rx-only-sterile-apotex-corp-ma/) Lack of Assurance of Sterility Class II Reported ongoing Distribution: U.S. Nationwide [Official source for Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%\*, 5 mL, Rx Only, Sterile, Apot...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0407-2026%22) Sep 5, 2025 FDA drug enforcement ### [Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, a) 5 mL and b) 10 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Richmond Hill, Ontario, Canada, L4C 5H...](https://isitonrecall.com/recall/fda-drug-d-0676-2025-brimonidine-tartrate-timolol-maleate-ophthalmic-solution-0-2-0-5-a-5-ml-and-b-10-ml-rx-only-sterile/) Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns Class II Reported ongoing Distribution: Nationwide in the US [Official source for Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, a) 5 mL and b) 10 mL, Rx Onl...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0676-2025%22) Sep 5, 2025 FDA drug enforcement ### [Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 5 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Richmond Hill, Ontario, Canada, L4C 5H2, Manufactured for: Apotex Corp., ...](https://isitonrecall.com/recall/fda-drug-d-0677-2025-ketorolac-tromethamine-ophthalmic-solution-0-5-5-ml-rx-only-sterile-manufactured-by-apotex-inc-richm/) Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns Class II Reported ongoing Distribution: Nationwide in the US [Official source for Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 5 mL, Rx Only, Sterile, Manufactured by: Apotex...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0677-2025%22) May 28, 2025 FDA drug enforcement ### [Lacosamide Oral Solution, USP, 10 mg/mL, 200 mL, Rx Only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston FL 33326, NDC 60...](https://isitonrecall.com/recall/fda-drug-d-0457-2025-lacosamide-oral-solution-usp-10-mg-ml-200-ml-rx-only-manufactured-by-apotex-inc-toronto-ontario-cana/) Defective Container: This recall is being initiated due to a leaking unit stored horizontally. Class II Reported ongoing Distribution: US Nationwide. [Official source for Lacosamide Oral Solution, USP, 10 mg/mL, 200 mL, Rx Only, Manufactured by: Apotex Inc., Toronto, ...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0457-2025%22) May 28, 2025 FDA drug enforcement ### [Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 10 mL, Rx Only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9, Manufactured for: Apotex Corp., Weston, FL 333...](https://isitonrecall.com/recall/fda-drug-d-0494-2025-ketorolac-tromethamine-ophthalmic-solution-0-5-10-ml-rx-only-manufactured-by-apotex-inc-toronto-onta/) Lack of Assurance of Sterility Class II Reported ongoing Distribution: US Nationwide. [Official source for Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 10 mL, Rx Only, Manufactured by: Apotex Inc., T...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0494-2025%22) May 28, 2025 FDA drug enforcement ### [Azelastine HCl Ophthalmic Solution, USP, 0.05%, 6 mL, Rx Only, Sterile, Mfg. by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9, Mfg. for: Apotex Corp., Weston, FL 33326, NDC 60...](https://isitonrecall.com/recall/fda-drug-d-0495-2025-azelastine-hcl-ophthalmic-solution-usp-0-05-6-ml-rx-only-sterile-mfg-by-apotex-inc-toronto-ontario-c/) Lack of Assurance of Sterility Class II Reported ongoing Distribution: US Nationwide. [Official source for Azelastine HCl Ophthalmic Solution, USP, 0.05%, 6 mL, Rx Only, Sterile, Mfg. by: Apotex Inc., Tor...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0495-2025%22) May 28, 2025 FDA drug enforcement ### [Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, 15 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9, Manufactured for: ...](https://isitonrecall.com/recall/fda-drug-d-0496-2025-brimonidine-tartrate-timolol-maleate-ophthalmic-solution-0-2-0-5-15-ml-rx-only-sterile-manufactured/) Lack of Assurance of Sterility Class II Reported ongoing Distribution: US Nationwide. [Official source for Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, 15 mL, Rx Only, Sterile, Man...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0496-2025%22) Feb 9, 2024 FDA drug enforcement ### [Fluticasone Propionate Nasal Spray USP 50mcg, 120 Metered Sprays - 16 g net fill, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9, Manufactured for: Apotex...](https://isitonrecall.com/recall/fda-drug-d-0326-2024-fluticasone-propionate-nasal-spray-usp-50mcg-120-metered-sprays-16-g-net-fill-rx-only-manufactured-b/) CGMP Deviations: potential presence of Burkholderia cepacia complex Class II Reported ongoing Distribution: Nationwide in the USA [Official source for Fluticasone Propionate Nasal Spray USP 50mcg, 120 Metered Sprays - 16 g net fill, Rx Only, Manufa...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0326-2024%22) Nov 1, 2023 FDA drug enforcement ### [Paroxetine Hydrochloride Tablets USP, RX only, 10 mg a) 30-count bottle, NDC#: 60505-0097-1; b) 100-count bottle, NDC#: 60505-0097-2; c) 1000-count bottle, NDC#: 60505-0097-4, M...](https://isitonrecall.com/recall/fda-drug-d-0119-2024-paroxetine-hydrochloride-tablets-usp-rx-only-10-mg-a-30-count-bottle-ndc-60505-0097-1-b-100-count-bo/) Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine Class II Reported ongoing Distribution: Nationwide [Official source for Paroxetine Hydrochloride Tablets USP, RX only, 10 mg a) 30-count bottle, NDC#: 60505-0097-1; b) 1...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0119-2024%22) Nov 1, 2023 FDA drug enforcement ### [Paroxetine Hydrochloride Tablets USP, RX only, 20 mg, a) 100-count bottle, NDC#:60505-0083-2; b) 1000-count bottle, NDC#: 60505-0083-4 Manufactured by: Apotex Inc., Toronto, Ont...](https://isitonrecall.com/recall/fda-drug-d-0120-2024-paroxetine-hydrochloride-tablets-usp-rx-only-20-mg-a-100-count-bottle-ndc-60505-0083-2-b-1000-count/) Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine Class II Reported ongoing Distribution: Nationwide [Official source for Paroxetine Hydrochloride Tablets USP, RX only, 20 mg, a) 100-count bottle, NDC#:60505-0083-2; b) ...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0120-2024%22) Nov 1, 2023 FDA drug enforcement ### [Paroxetine Hydrochloride Tablets USP, RX only, 30 mg, a)30-count bottle, NDC#: 60505-0084-1, b)100-count bottle, NDC#:60505-0084-2, c)1000-count bottle, NDC#: 60505-0084-4, Manu...](https://isitonrecall.com/recall/fda-drug-d-0121-2024-paroxetine-hydrochloride-tablets-usp-rx-only-30-mg-a-30-count-bottle-ndc-60505-0084-1-b-100-count-bo/) Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine Class II Reported ongoing Distribution: Nationwide [Official source for Paroxetine Hydrochloride Tablets USP, RX only, 30 mg, a)30-count bottle, NDC#: 60505-0084-1, b)10...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0121-2024%22) Nov 1, 2023 FDA drug enforcement ### [Paroxetine Hydrochloride Tablets USP, RX only, 40 mg, 1000-count bottle, NDC#:60505-0101-4 Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apot...](https://isitonrecall.com/recall/fda-drug-d-0122-2024-paroxetine-hydrochloride-tablets-usp-rx-only-40-mg-1000-count-bottle-ndc-60505-0101-4-manufactured-b/) Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine Class II Reported ongoing Distribution: Nationwide [Official source for Paroxetine Hydrochloride Tablets USP, RX only, 40 mg, 1000-count bottle, NDC#:60505-0101-4 Manufa...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0122-2024%22) Apr 26, 2023 FDA drug enforcement ### [Calcitonin Salmon (synthetic origin) Nasal Spray, 2200 USP Calcitonin Salmon Units/mL, 200 USP Calcitonin Salmon Units/spray, 3.7 mL bottle, Rx only, Manufactured by: Apotex Cor...](https://isitonrecall.com/recall/fda-drug-d-0568-2023-calcitonin-salmon-synthetic-origin-nasal-spray-2200-usp-calcitonin-salmon-units-ml-200-usp-calcitoni/) Presence of Foreign Substance: Glass splinter particle entrapped inside the pump ball seat rendered the pump inoperable. Class II Reported completed Distribution: Nationwide throughout the United States [Official source for Calcitonin Salmon (synthetic origin) Nasal Spray, 2200 USP Calcitonin Salmon Units/mL, 200 USP Ca...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0568-2023%22) Mar 1, 2023 FDA drug enforcement ### [Brimonidine Tartrate Ophthalmic Solution 0.15%, Rx Only, Packaged as: a) 5 mL dropper bottle, NDC 60505-0564-1, UPC 3 60505 05641 5; b) 10 mL dropper bottle NDC 60505-0564-2, UP...](https://isitonrecall.com/recall/fda-drug-d-0433-2023-brimonidine-tartrate-ophthalmic-solution-0-15-rx-only-packaged-as-a-5-ml-dropper-bottle-ndc-60505-05/) 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. Class II Reported completed Distribution: Nationwide in the USA [Official source for Brimonidine Tartrate Ophthalmic Solution 0.15%, Rx Only, Packaged as: a) 5 mL dropper bottle, NDC...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0433-2023%22) Dec 21, 2022 FDA drug enforcement ### [Timolol Maleate Ophthalmic Solution, USP 0.5%, 2.5 mL, Rx Only, Mfg by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Mfg for: Apotex Corp. Weston, FL 33326, NDC 60505-1005-4](https://isitonrecall.com/recall/fda-drug-d-0093-2023-timolol-maleate-ophthalmic-solution-usp-0-5-2-5-ml-rx-only-mfg-by-apotex-inc-toronto-ontario-canada/) 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. Class III Reported terminated Distribution: USA Nationwide [Official source for Timolol Maleate Ophthalmic Solution, USP 0.5%, 2.5 mL, Rx Only, Mfg by: Apotex Inc. Toronto, Onta...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0093-2023%22) Jul 7, 2022 FDA drug enforcement ### [Aripiprazole Tablets, USP 20 mg, packaged in a) 1,000-count bottle (NDC 60505-2676-8, UPC 3 60505 26768 2), b) 30-count bottle (NDC 60505-2676-3, UPC 3 60505 26763 7), Rx only, ...](https://isitonrecall.com/recall/fda-drug-d-1285-2022-aripiprazole-tablets-usp-20-mg-packaged-in-a-1-000-count-bottle-ndc-60505-2676-8-upc-3-60505-26768-2/) Failed dissolution specifications: OOS for dissolution at the 12-month stability time point. Class II Reported terminated Distribution: USA Nationwide [Official source for Aripiprazole Tablets, USP 20 mg, packaged in a) 1,000-count bottle (NDC 60505-2676-8, UPC 3 60505...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-1285-2022%22) May 3, 2022 FDA drug enforcement ### [Sirolimus Oral Solution, 1 mg/mL, 60 mL bottle, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326, NDC 6...](https://isitonrecall.com/recall/fda-drug-d-0881-2022-sirolimus-oral-solution-1-mg-ml-60-ml-bottle-rx-only-manufactured-by-apotex-inc-toronto-ontario-cana/) Failed Dissolution Specifications: Sirolimus Oral Solution recalled due to lot RZ1598 exceeded the specification limit at the 14-month timepoint. Class III Reported terminated Distribution: Nationwide in the USA [Official source for Sirolimus Oral Solution, 1 mg/mL, 60 mL bottle, Rx Only, Manufactured by: Apotex Inc. Toronto, On...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0881-2022%22) ## Reasons in these listed records - Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria - Defective container: defect in a batch of bottle caps, specifically involving dislodged or missing cap liners. - Lack of Assurance of Sterility - Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns These examples come from this result page and are not a ranking of every recall reason. ## Checking Apotex Corp. ### Is there a recall on apotex corp. right now? This archive contains 19 records, including 14 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search Apotex Corp.](https://isitonrecall.com/check/?q=Apotex%20Corp.) 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