CLASS II ONGOING Drug recall · Reported 2 Jul 2025 · FDA Enforcement Report
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5% recalled
Apotex is recalling Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, distributed nationwide in the US. The recall was initiated on 28 May 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0496-2025
- FDA event ID
- 96954
- Recalling firm
- Apotex, Weston, FL
- Manufacturer
- Apotex Corp.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 28 May 2025
- FDA classified
- 25 Jun 2025
- Reported
- 2 Jul 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Eye Drops
Timeline
| 28 May 2025 | Recall initiated by company | |
| 25 Jun 2025 | Classified by FDA | +28 days |
| 2 Jul 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
US Nationwide.
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility
Which lots are affected?
Batch VC6058, Exp Date: 10/31/2025
Where was it sold?
US Nationwide.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 96954This product is part of a recall event; the main page for the event is Ketorolac Tromethamine Ophthalmic Solution recalled by Apotex.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Ketorolac Tromethamine Ophthalmic Solution recalled by ApotexKetorolac Tromethamine | Apotex | Sterility | Nationwide | |
| CLASS II | Azelastine HCl Ophthalmic Solution recalled by ApotexAzelastine Hydrochloride | Apotex | Sterility | Nationwide |
More recalls from Apotex
All 75| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg recalled | Apotex | Potency & Assay | Nationwide |
| Drug | CLASS II | Desmopressin Nasal Spray, USP, 10 mcg/ bottle (50 doses) recalled | Apotex | Other | Nationwide |
| Drug | CLASS II | Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%* recalledBrimonidine Tartrate/timolol Maleate Ophthalmic Solution | Apotex | Sterility | Nationwide |
| Drug | CLASS II | Ketorolac Tromethamine Ophthalmic Solution recalled by ApotexKetorolac Tromethamine | Apotex | Sterility | Nationwide |
| Drug | CLASS II | Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution recalledBrimonidine Tartrate/timolol Maleate Ophthalmic Solution | Apotex | Sterility | Nationwide |
Other Brimonidine recalls
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%* recalledBrimonidine Tartrate/timolol Maleate Ophthalmic Solution | Apotex | Sterility | Nationwide |
| Drug | CLASS II | Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution recalledBrimonidine Tartrate/timolol Maleate Ophthalmic Solution | Apotex | Sterility | Nationwide |
| Drug | CLASS II | Brimonidine Tartrate Ophthalmic Solution recalled by ApotexBrimonidine Tartrate | Apotex | Sterility | Nationwide |
| Drug | CLASS III | Brimonidine Tartrate Opthalmic Solution recalledBrimonidine Tartrate | Somerset Therapeutics | Potency & Assay | Nationwide |
| Drug | CLASS III | Brimonidine Tartrate Opthalmic Solution recalledBrimonidine Tartrate | Somerset Therapeutics | Potency & Assay | Nationwide |