Medications & Supplements/Prescription Drugs

Ciprofloxacin Eye Drops Recalled for Defective Dispensing Bottle

Agency Publication Date: March 17, 2025

Summary

Leading Pharma LLC is recalling 90,960 bottles of Ciprofloxacin Ophthalmic Solution USP, 0.3% (ciprofloxacin) because of a manufacturing defect in the container. The spike of the cap can become lodged inside the nozzle, preventing the medication from being dispensed from the bottle. If you are using this medication, contact your healthcare provider or pharmacist for guidance regarding your treatment.

Risk

The defective container makes it impossible to access the eye drops, which can lead to a delay in treating eye infections. This delay could result in the worsening of the patient's condition while they are unable to administer their prescribed treatment.

What You Should Do

This recall affects Ciprofloxacin Ophthalmic Solution USP, 0.3% distributed by Leading Pharma LLC, packaged in 5 mL bottles.
Identify the affected product by looking for lot number 084A067 with an expiration date of 12/31/2025. The carton will display NDC 69315-308-05.
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 the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 for more information about this recall.

Your Remedy Options

You have 2 options:

Option 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

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% (5 mL)

Variants: 0.3% as base, 5 mL bottle

Lot Numbers:

084A067 (Exp 12/31/2025)

NDC:

69315-308-05

Distributed by Leading Pharma LLC.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 96495

Status: Active

Manufacturer: FDC Limited

Sold By: Retail Pharmacies; Healthcare Providers

Manufactured In: India

Units Affected: 90960 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 · 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.

Summary

What You Should Do

This recall affects Ciprofloxacin Ophthalmic Solution USP, 0.3% distributed by Leading Pharma LLC, packaged in 5 mL bottles.

Identify the affected product by looking for lot number 084A067 with an expiration date of 12/31/2025. The carton will display NDC 69315-308-05.

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 the manufacturer for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 for more information about this recall.