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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

Timolol Maleate Ophthalmic Solution Recalled for Defective Container

Agency Publication Date: July 29, 2025
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Summary

FDC Limited is recalling approximately 154,176 bottles of Timolol Maleate Ophthalmic Solution USP, 0.5% (5mL) because of a container defect. The spike inside the bottle cap can become lodged in the nozzle, making it impossible for the medication to be dispensed. If you use this medication to manage eye pressure, please contact your healthcare provider or pharmacist to arrange for a replacement, as the bottle may be unusable.

Risk

The defective cap spike can block the bottle's nozzle, preventing users from administering their prescribed eye drops. This could lead to a interruption in treatment for conditions like glaucoma, potentially resulting in increased eye pressure.

What You Should Do

  1. This recall affects 5mL bottles of Timolol Maleate Ophthalmic Solution USP, 0.5% sold under NDC 64980-514-05, specifically lot number 083L061 with an expiration date of 11/2025.
  2. If you have health concerns about your eye treatment or have experienced difficulty dispensing this medication, contact your healthcare provider or pharmacist immediately.
  3. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer, FDC Limited, 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: Timolol Maleate Ophthalmic Solution USP, 0.5% (5mL)
Variants: Sterile, Rx Only
Lot Numbers:
083L061 (Exp 11/2025)
NDC:
64980-514-05

Distributed by Rising Pharmaceuticals Inc; Manufactured by FDC Limited.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97219
Status: Active
Manufacturer: FDC Limited
Sold By: Rising Pharmaceuticals Inc
Manufactured In: India
Units Affected: 154,176 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.