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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Topical Products

Apotex Ophthalmic Solutions Recalled for Potential Sterility Concerns

Agency Publication Date: September 30, 2025
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Summary

Apotex Corp. is recalling 644,502 bottles of Brimonidine Tartrate/Timolol Maleate and Ketorolac Tromethamine eye drops because some bottles may not be properly sealed. This improper sealing can lead to the medicine losing its sterility or leaking, which was noticed during testing as an unusual loss of weight in the bottles. The recall affects several lots of prescription eye drops used to treat eye pressure and inflammation.

Risk

If an eye drop solution is not sterile, it can become contaminated with bacteria or other germs. Using contaminated eye drops directly on the eye can lead to serious eye infections, which could potentially cause permanent vision loss or other severe health complications.

What You Should Do

  1. Check your eye drop bottles and outer cartons for the following lot numbers and NDC codes: Brimonidine/Timolol (NDC 60505-0589-1 and 60505-0589-2) lots VE0614 and VE0616; or Ketorolac Tromethamine (NDC 60505-1003-1) batches VA0444, VA4608, and TZ7016.
  2. If you have health concerns or are unsure if you should continue your treatment, contact your healthcare provider or pharmacist for guidance.
  3. Return any unused product to the place of purchase for a refund, throw it away, or contact Apotex Corp. directly for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 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
๐Ÿ—‘๏ธ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: Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%
Variants: 5 mL, 10 mL, Ophthalmic Solution
UPC Codes:
00360505058914
0360505058921
Lot Numbers:
VE0614 (Exp 12/2025)
VE0616 (Exp 12/2025)
NDC:
60505-0589-1
60505-0589-2

Manufactured by Apotex Inc., Richmond Hill, Ontario, Canada.

Product: Ketorolac Tromethamine Ophthalmic Solution, 0.5%
Variants: 5 mL, Ophthalmic Solution
UPC Codes:
0360505100316
360505100316
Lot Numbers:
VA0444 (Exp 01/2026)
VA4608 (Exp 01/2026)
TZ7016 (Exp 12/2025)
NDC:
60505-1003-1

Manufactured by Apotex Inc., Richmond Hill, Ontario, Canada.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97561
Status: Active
Manufacturer: Apotex Corp.
Sold By: pharmacies; hospitals
Manufactured In: Canada, United States
Units Affected: 2 products (151,034 bottles; 493,468 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 ยท 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.