Brimonidine Tartrate/timolol Maleate Ophthalmic Solution
FDA Recall NDC 60505-0589
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 3 recorded enforcement report(s) associated with Brimonidine Tartrate/timolol Maleate Ophthalmic Solution (NDC 60505-0589). A significant event, classified as Class II, was initiated on Mar 05, 2026 by Apotex Corp.. The reported reason for this action was: "Lack of Assurance of Sterility"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Lack of Assurance of Sterility
Mar 05, 2026
Mar 25, 2026
107,136 vials
Recall Profile & Regulatory Data
Event ID
98536
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Apotex Corp.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S. Nationwide
Product Description
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.
Batch or Lot Expiration Information
Lot# Lots VJ8599, Exp Date 09/30/2026 & VL1668, Exp Date 01/31/2027
Affected Packages Involved in this Recall
60505-0589-1Product
60505-0589-2Product
60505-0589-3Product
September 2025 Class II Recall: Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
Recall Number
Class II Ongoing
Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
Sep 05, 2025
Oct 08, 2025
151,034 bottles
Recall Profile & Regulatory Data
Event ID
97561
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Apotex Corp.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the US
Product Description
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 5H2, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0589-1 (5 mL), NDC 60505-0589-2 (10 mL).
Batch or Lot Expiration Information
Lot# a)
Lot# VE0614 exp. date 12/2025 UPC:(01)00360505058914 (5 mL) b)
Lot# VE0616 exp. date 12/2025 UPC:(01)0(03)60505058921 (10 mL)
Affected Packages Involved in this Recall
60505-0589-1Product
60505-0589-2Product
60505-0589-3Product
0036050505Product
6050505892Product
Class II Ongoing
Lack of Assurance of Sterility
May 28, 2025
Jul 02, 2025
6,288 Bottles
Recall Profile & Regulatory Data
Event ID
96954
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Apotex Corp.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US Nationwide.
Product Description
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: Apotex Corp., Weston, FL 33326, NDC 60505-0589-3
Batch or Lot Expiration Information
Batch# Batch VC6058, Exp Date: 10/31/2025
Affected Packages Involved in this Recall
60505-0589-1Product
60505-0589-2Product
60505-0589-3Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
