Quick Facts at a Glance
- Recall Date
- September 5, 2025
- Hazard Level
- HIGH
- Brands
- BRIMONIDINE TARTRATE/TIMOLOL MALEATE OPHTHALMIC SOLUTION, Apotex Corp.
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- PREGNANT, GENERAL, ELDERLY
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- BRIMONIDINE TARTRATE/TIMOLOL MALEATE OPHTHALMIC SOLUTION, Apotex Corp.
- Product type
- Ophthalmic Solution
- Model numbers
- a) lot VE0614 exp. date 12/2025 UPC: 01 00360505058914 (5 mL), b) lot VE0616 exp. date 12/2025 UPC: 01 0 3060505058921 (10 mL)
- UPC codes
- 60505-0589, 60505-0589-1, 60505-0589-2, 60505-0589-3, 0036050505, 6050505892
- Sizes
- 5 mL, 10 mL
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
September 5, 2025
Reported by FDA DRUG
October 8, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
What You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact Apotex Corp. or your healthcare provider for guidance. Notification method: Letter
About This Product
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution is a prescription eye drop used to reduce intraocular pressure in glaucoma or ocular hypertension. Patients rely on timely dosing, often daily.
Why This Is Dangerous
A lack of sterility could expose patients to eye infections or other complications. Improper sealing led to weight loss anomalies noted in packaging; while weight loss is not a typical indicator of sterility, the primary concern is sterility.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Consumers may face vision risks and require medical evaluation if exposed to non-sterile drops. Replacements or refunds may be issued through manufacturer channels.
Practical Guidance
How to identify if yours is affected
- Check NDC 60505-0589-1 for 5 mL bottles
- Check NDC 60505-0589-2 for 10 mL bottles
- Look for lot VE0614 or VE0616 and expiration 12/2025
- Verify product meets packaging seals at top and seal integrity on bottle
Where to find product info
FDA recall page D-0676-2025 and Apotex Corp. communications
What timeline to expect
Refunds or replacements typically processed within 4-8 weeks after submission
If the manufacturer is unresponsive
- Document all communications
- Escalate to consumer protection offices
- File a complaint with FDA if there is continued inaction
How to prevent similar issues
- Check for proper bottle sealing during purchase
- Avoid bottles with damaged seals
- Verify NDC numbers on label before use
- Ask for patient information leaflet at dispensing
Documentation advice
Keep recall notice, receipts, serial numbers, and photos of packaging
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Product Details
Brand: BRIMONIDINE TARTRATE/TIMOLOL MALEATE OPHTHALMIC SOLUTION. Manufacturer: Apotex Inc., Richmond Hill, Ontario, Canada. For: Apotex Corp., Weston, FL. NDC 60505-0589-1 (5 mL) and 60505-0589-2 (10 mL). Lot numbers VE0614 and VE0616. Expiration 12/2025 for both lots. Distribution: Nationwide in the United States. Quantity: 151,034 bottles.
Reported Incidents
No injuries or incidents have been reported in the provided data.
Key Facts
- Lot VE0614 (5 mL) and VE0616 (10 mL)
- Exp. 12/2025 for both lots
- Nationwide distribution in the US
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Safety Guide
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