Quick Facts at a Glance
- Recall Date
- September 5, 2025
- Hazard Level
- HIGH
- Brands
- Apotex, Ketorolac Tromethamine
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
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
- Apotex, Ketorolac Tromethamine
- Product type
- Ophthalmic Solution
- Model numbers
- VA0444, VA4608, TZ7016
- UPC codes
- 60505-1003, 60505-1003-1, 60505-1003-2, 6050510031, 3605051003
- Sizes
- 5 mL
- Sold at
- Multiple Retailers
- 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
Ketorolac Tromethamine Ophthalmic Solution is a sterile eye drop used to treat eye pain and inflammation. The product is sold as a prescription medicine and distributed nationwide.
Why This Is Dangerous
A lack of sterility can allow microbial contamination, potentially causing eye infections or other complications in patients.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Patients with affected bottles may be exposed to contaminated solution. The risk is primarily eye infection which could require medical treatment.
Practical Guidance
How to identify if yours is affected
- Verify NDC 60505-1003-1 on the product packaging.
- Check batch numbers VA0444, VA4608, TZ7016.
- Confirm expiry: VA0444/VA4608 expire 01/2026; TZ7016 expire 12/2025.
- Look for UPCs on bottles and cartons: Bottles 360505100316; Bottle UPC variant (01)0(03)60505100316.
Where to find product info
Review the FDA recall page for D-0677-2025 and Apotex recall notice for batch and disposal instructions.
What timeline to expect
No specific refund or replacement timeline is provided in the recall notice. Follow official guidance for disposal or replacement; expect updates from
If the manufacturer is unresponsive
- Contact Apotex via the recall notice.
- Consult your pharmacy or healthcare provider for guidance.
- If needed, file a consumer complaint with the FDA.
How to prevent similar issues
- Buy medications only from reputable pharmacies and verify packaging integrity before use.
- Check NDC and batch numbers when acquiring prescription eye drops.
- Inspect bottles for signs of leakage or damaged seals before use.
Documentation advice
Keep the recall letter, product packaging, batch numbers, and purchase receipts. Document all communications with the manufacturer and healthcare providers.
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Product Details
Product: Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 5 mL. NDC 60505-1003-1. Manufactured by Apotex Inc., Richmond Hill, Ontario, Canada. Manufactured for Apotex Corp., Weston, FL 33326. Batch numbers: VA0444, VA4608, TZ7016. Expiry: VA0444/VA4608 01/2026; TZ7016 12/2025. UPC: Bottles 360505100316; Bottles UPC on bottle: (01)0(03)60505100316. Quantity: 493,468 bottles. Distribution: Nationwide in the United States. Sold as Rx Only.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Batch VA0444 VA4608 TZ7016
- Distributed nationwide in the U.S.
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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