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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/Prescription Drugs

Apotex Brimonidine/Timolol Ophthalmic Solution Recalled for Sterility Concerns

Agency Publication Date: March 16, 2026
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Summary

Apotex Corp. is recalling 107,136 vials of Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%, a prescription eye drop used to treat glaucoma. This recall was initiated due to a lack of assurance of sterility for certain batches. Consumers who have this medication should check their packaging for specific lot numbers and expiration dates. It is important to consult with a doctor or pharmacist before stopping use or disposing of this medication to ensure your eye condition remains properly managed.

Risk

If an ophthalmic solution is not sterile, it may contain microorganisms that can cause serious eye infections or other complications when applied directly to the eye.

What You Should Do

  1. Check your 5 mL eye drop vials for the product name Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5% and NDC number 60505-0589-1.
  2. Verify if your product belongs to lot VJ8599 (Expiration 09/30/2026) or lot VL1668 (Expiration 01/31/2027).
  3. 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.
  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% (5 mL)
Variants: Rx Only, Sterile
Lot Numbers:
VJ8599 (Exp Date 09/30/2026)
VL1668 (Exp Date 01/31/2027)
NDC:
60505-0589-1

Manufactured for Apotex Corp., Weston, FL

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98536
Status: Active
Manufacturer: Apotex Corp.
Sold By: Wholesalers; Retail Pharmacies
Manufactured In: United States
Units Affected: 107,136 vials
Distributed To: Nationwide
Agency Last Updated: April 1, 2026

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.