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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

Leading Pharma Ciprofloxacin Eye Drops Recalled for Defective Bottles

Agency Publication Date: January 3, 2025
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Summary

This recall affects approximately 136,181 bottles of Leading Pharma Ciprofloxacin Ophthalmic Solution USP (0.3%), an antibiotic eye drop used to treat bacterial eye infections. The 5 mL bottles are being recalled because of a mechanical defect where the cap spike becomes stuck in the bottle's nozzle, making it impossible to dispense the medication. If you cannot get the solution out of the bottle, your infection may go untreated, potentially leading to worsening symptoms.

Risk

The defective container prevents the medication from being administered as prescribed. A delay or interruption in treating a bacterial eye infection can cause the condition to worsen, potentially leading to more severe ocular symptoms or complications.

What You Should Do

  1. This recall affects Leading Pharma Ciprofloxacin Ophthalmic Solution USP (0.3% as base), sterile eye drops packaged in 5 mL bottles with NDC 69315-308-05.
  2. Check your bottle or carton for lot numbers 083L111 (Exp. 11/30/2025) or 084A032 (Exp. 12/31/2025).
  3. If you have health concerns about an untreated infection, contact your healthcare provider or pharmacist immediately.
  4. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer, FDC Limited, for further instructions.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information.

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: Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, Sterile (5 mL)by Leading Pharma
Variants: 0.3%, 5 mL Bottle
Lot Numbers:
083L111 (Exp. 11/30/2025)
084A032 (Exp. 12/31/2025)
NDC:
69315-308-05

Distributed by Leading Pharma LLC, Fairfield, NJ.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96014
Status: Active
Manufacturer: FDC Limited
Manufactured In: India
Units Affected: 136,181 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.