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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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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Timolol Maleate Ophthalmic Solution Recalled for Potential Potency Loss

Agency Publication Date: December 28, 2022
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Summary

Apotex Corp. is voluntarily recalling 22,027 bottles of Timolol Maleate Ophthalmic Solution, USP 0.5% (2.5 mL size). The recall was issued because the medication failed stability tests due to liquid weight loss from the container, which can result in the medicine being stronger or weaker than intended. This prescription drug is typically used to lower pressure in the eyes for patients with conditions like glaucoma.

Risk

The drug may have lost its required potency over time because of excessive evaporation from the bottle. If the medication is not at the correct strength, it may not effectively treat high eye pressure, potentially leading to a worsening of the patient's vision or eye health.

What You Should Do

  1. This recall affects 2.5 mL bottles of Timolol Maleate Ophthalmic Solution, USP 0.5% identified by NDC 60505-1005-4 and lot number TA4844 with an expiration date of 03/2023.
  2. If you have health concerns regarding your eye treatment, contact your healthcare provider or pharmacist immediately.
  3. Return any unused product to the pharmacy or 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.

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: Timolol Maleate Ophthalmic Solution, USP 0.5% (2.5 mL)
Variants: USP 0.5%, 2.5 mL, Rx Only
Lot Numbers:
TA4844 (Exp 03/2023)
NDC:
60505-1005-4

Recall Number: D-0093-2023

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 91353
Status: Resolved
Manufacturer: Apotex Corp.
Sold By: Pharmacies
Manufactured In: United States, Canada
Units Affected: 22,027 bottles
Distributed To: Nationwide

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.