Multi-event September 2025 FDA Recall Brimonidine Tartrate/timolol Maleate Ophthalmic Solution by Apotex Corp.
This Multi-event Class II drug recall was voluntarily initiated by Apotex Corp. on September 5, 2025 for the product Brimonidine Tartrate/timolol Maleate Ophthalmic Solution. The FDA reported the reason for recall as lack of assurance of sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns. The product was distributed Nationwide and the recall is currently ongoing.
Reported Recall Events
Recall Number: D-0677-2025
Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
09-05-2025
10-08-2025
493,468 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Apotex Corp.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the US
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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., Weston, FL 33326, NDC 60505-1003-1.
Batch or Lot Expiration Information
Batch# VA0444, exp. date 01/2026
Batch# VA4608, exp. date 01/2026
Batch# TZ7016, exp. date 12/2025 UPC on Bottles: (01)0(03)60505100316 UPC on Cartons: 360505100316
Affected Packages Involved in this Recall
Recall Number: D-0676-2025
Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
09-05-2025
10-08-2025
151,034 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Apotex Corp.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the US
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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)
