Reported Oct 8, 2025 · Ongoing
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, a) 5 mL and b) 10 mL, Rx Only, Sterile,…
Apotex Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Apotex Corp. · 2400 N Commerce Pkwy Ste 400 · Weston, FL · 33326-3253
Is this the product you have?
- Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, a) 5 mL and b) 10 mL, Rx Only, Sterile
- Manufactured byApotex Inc., Richmond Hill, Ontario, Canada, L4C 5H2
- Manufactured for
Apotex CorpWestonFL 33326NDC 60505-0589-1 (5 mL)NDC 60505-0589-2 (10 mL)
- Lot codes and dates
- 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)
- Amount recalled
- 151,034 bottles
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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