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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 Tartrate Eye Drops Recalled for Potential Lack of Sterility

Agency Publication Date: March 3, 2023
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Summary

Apotex Corp. is voluntarily recalling 67,056 bottles of Brimonidine Tartrate Ophthalmic Solution 0.15%, a prescription eye drop (Brimonidine Tartrate) used to lower eye pressure in patients with glaucoma or ocular hypertension. The recall was issued because cracks were discovered in the bottle caps, which could allow contaminants into the bottle and compromise the sterility of the medicine. No injuries or adverse events related to this issue have been reported to date.

Risk

A cracked bottle cap could compromise the sterile seal of the eye drops, allowing bacteria or other contaminants to enter the solution. Using non-sterile eye medication poses a serious risk of eye infections and other related health complications.

What You Should Do

  1. This recall affects Brimonidine Tartrate Ophthalmic Solution 0.15% packaged in 5 mL (NDC 60505-0564-1), 10 mL (NDC 60505-0564-2), and 15 mL (NDC 60505-0564-3) dropper bottles.
  2. Check your medication bottle and outer carton for lot numbers TJ9848, TJ9849, TK0258, TK5341, TK0261, or TK0262 with expiration dates of February 2024 or April 2024.
  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 Apotex Corp. for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) if you have additional questions or wish to report a concern.

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 Ophthalmic Solution 0.15% (5 mL)
Variants: 5 mL dropper bottle, Rx Only
UPC Codes:
360505056415
Lot Numbers:
TJ9848 (Exp. 02/2024)
TJ9849 (Exp. 02/2024)
TK0258 (Exp. 04/2024)
TK5341 (Exp. 04/2024)
NDC:
60505-0564-1

Manufactured by Apotex Inc. Toronto, Ontario Canada.

Product: Brimonidine Tartrate Ophthalmic Solution 0.15% (10 mL)
Variants: 10 mL dropper bottle, Rx Only
UPC Codes:
360505056422
Lot Numbers:
TK0261 (Exp. 04/2024)
NDC:
60505-0564-2

Manufactured by Apotex Inc. Toronto, Ontario Canada.

Product: Brimonidine Tartrate Ophthalmic Solution 0.15% (15 mL)
Variants: 15 mL dropper bottle, Rx Only
UPC Codes:
360505056439
Lot Numbers:
TK0262 (Exp. 04/2024)
NDC:
60505-0564-3

Manufactured by Apotex Inc. Toronto, Ontario Canada.

Product Images

Image 1 โ€“ Labeling,  Brimonidine Tartrate Ophthalmic Solution, 0.15%, Bottle Label

Image 1 โ€“ Labeling, Brimonidine Tartrate Ophthalmic Solution, 0.15%, Bottle Label

Image 2 โ€“ Labeling,  Brimonidine Tartrate Ophthalmic Solution, 0.15%, Carton Label

Image 2 โ€“ Labeling, Brimonidine Tartrate Ophthalmic Solution, 0.15%, Carton Label

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 91803
Status: Resolved
Manufacturer: Apotex Corp.
Sold By: Pharmacies nationwide
Manufactured In: Canada, United States
Units Affected: 67,056 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 FDA Press Release 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.