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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 Bottle Nozzle

Agency Publication Date: May 5, 2025
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Summary

FDC Limited is recalling approximately 60,428 bottles of Timolol Maleate Ophthalmic Solution USP, 0.5% (10mL), a prescription medication used to treat high pressure in the eye. The recall was initiated because the spike inside the bottle cap can become stuck in the nozzle, preventing the solution from being dispensed. This defect may cause patients to miss their prescribed doses.

Risk

If the nozzle is blocked, the patient cannot dispense the medication, which can lead to poorly controlled eye pressure and potential progression of eye conditions like glaucoma. No injuries have been reported to date.

What You Should Do

  1. The recalled product is Timolol Maleate Ophthalmic Solution USP, 0.5%, sold in 10mL bottles with NDC 64980-514-01 and Lot Number 083I098 (Expiration Date 08/31/2025).
  2. If you have health concerns regarding missed doses or your eye condition, 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 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% (10mL)by Rising Pharmaceuticals
Variants: 0.5% Strength, 10mL Bottle, Sterile
Lot Numbers:
083I098 (Exp. 08/31/2025)
NDC:
64980-514-01

Distributed by Rising Pharmaceuticals Inc, New Jersey. Manufactured by FDC Limited, Waluj, Aurangabad, India.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96740
Status: Active
Manufacturer: FDC Limited
Sold By: Pharmacies
Manufactured In: India
Units Affected: 60428 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.