Medications & Supplements/Prescription Drugs

Apotex Eye Drops Recalled for Lack of Sterility Assurance

Agency Publication Date: June 25, 2025

Summary

Apotex Corp. is voluntarily recalling approximately 199,584 bottles of three different prescription eye drop solutions: Ketorolac Tromethamine (0.5%), Azelastine HCl (0.05%), and Brimonidine Tartrate/Timolol Maleate (0.2%/0.5%). The recall was initiated because the company cannot guarantee the sterility of these medications. These products were distributed nationwide in the United States and consumers are advised to contact their healthcare provider or pharmacist regarding their treatment.

Risk

If an eye drop solution is not sterile, it can introduce bacteria or other contaminants directly into the eye, potentially causing serious infections or vision-threatening complications. No injuries or adverse events have been reported to date.

What You Should Do

This recall affects three prescription eye drop products: Ketorolac Tromethamine Ophthalmic Solution 0.5% (10 mL), Azelastine HCl Ophthalmic Solution 0.05% (6 mL), and Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5% (15 mL).
Identify if your product is affected by checking the NDC and Batch codes on the packaging: Ketorolac Tromethamine (NDC 60505-1003-2, Batch TZ1236, Exp 11/30/2025), Azelastine HCl (NDC 60505-0578-4, Batch VD1654, Exp 06/30/2027), or Brimonidine/Timolol (NDC 60505-0589-3, Batch VC6058, Exp 10/31/2025).
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Ketorolac Tromethamine Ophthalmic Solution, 0.5% (10 mL)

Variants: 0.5%, 10 mL

Lot Numbers:

TZ1236 (Exp 11/30/2025)

NDC:

60505-1003-2

Quantity: 87,840 bottles

Product: Azelastine HCl Ophthalmic Solution, USP, 0.05% (6 mL)

Variants: 0.05%, 6 mL

Lot Numbers:

VD1654 (Exp 06/30/2027)

NDC:

60505-0578-4

Quantity: 105,456 Bottles

Product: Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5% (15 mL)

Variants: 0.2%/0.5%, 15 mL

Lot Numbers:

VC6058 (Exp 10/31/2025)

NDC:

60505-0589-3

Quantity: 6,288 Bottles

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 96954

Status: Active

Manufacturer: Apotex Corp.

Sold By: Pharmacies; Hospitals; Healthcare Providers

Manufactured In: Canada

Units Affected: 3 products (87,840 bottles; 105,456 Bottles; 6,288 Bottles)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects three prescription eye drop products: Ketorolac Tromethamine Ophthalmic Solution 0.5% (10 mL), Azelastine HCl Ophthalmic Solution 0.05% (6 mL), and Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5% (15 mL).

Identify if your product is affected by checking the NDC and Batch codes on the packaging: Ketorolac Tromethamine (NDC 60505-1003-2, Batch TZ1236, Exp 11/30/2025), Azelastine HCl (NDC 60505-0578-4, Batch VD1654, Exp 06/30/2027), or Brimonidine/Timolol (NDC 60505-0589-3, Batch VC6058, Exp 10/31/2025).

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Ketorolac Tromethamine Ophthalmic Solution, 0.5% (10 mL)

Variants: 0.5%, 10 mL

Lot Numbers:

TZ1236 (Exp 11/30/2025)

NDC:

60505-1003-2

Quantity: 87,840 bottles

Product: Azelastine HCl Ophthalmic Solution, USP, 0.05% (6 mL)

Variants: 0.05%, 6 mL

Lot Numbers:

VD1654 (Exp 06/30/2027)

NDC:

60505-0578-4

Quantity: 105,456 Bottles

Product: Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5% (15 mL)

Variants: 0.2%/0.5%, 15 mL

Lot Numbers:

VC6058 (Exp 10/31/2025)

NDC:

60505-0589-3

Quantity: 6,288 Bottles