Medications & Supplements/Prescription Drugs

Ciprofloxacin Ophthalmic Solution Recalled for Defective Container

Agency Publication Date: August 1, 2024

Summary

FDC Limited is recalling approximately 66,528 bottles of Ciprofloxacin ophthalmic solution (0.3% as base), an antibiotic eye drop, because the bottles are defective. A spike from the cap can become stuck inside the nozzle, making it impossible to get the medicine out of the bottle. The affected bottles were distributed nationwide by Leading Pharma LLC in 2.5 mL and 10 mL sizes.

Risk

The defective container prevents patients from accessing their prescribed medication. If a patient cannot administer these antibiotic eye drops, their eye infection may go untreated, potentially leading to worsening symptoms or further complications.

What You Should Do

The recalled products are Ciprofloxacin ophthalmic solution USP, 0.3% as base, packaged in 2.5 mL bottles (NDC 69315-308-02) and 10 mL bottles (NDC 69315-308-10).
Check your medication for lot number 084C040 (Exp 02/28/2026) on 10 mL bottles or lot number 084A024 (Exp 12/31/2025) on 2.5 mL bottles.
If you find that the solution will not come out of the bottle, do not attempt to puncture the nozzle or force the medication out.
If you have health concerns about missed doses, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact FDC Limited for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

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% as base (10 mL)

Variants: 0.3% strength, 10 mL bottle

Lot Numbers:

084C040 (Exp 02/28/2026)

NDC:

69315-308-10

Distributed by Leading Pharma LLC

Product: Ciprofloxacin ophthalmic solution USP, 0.3% as base (2.5 mL)

Variants: 0.3% strength, 2.5 mL bottle

Lot Numbers:

084A024 (Exp 12/31/2025)

NDC:

69315-308-02

Distributed by Leading Pharma LLC

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 95027

Status: Active

Manufacturer: FDC Limited

Sold By: Leading Pharma LLC; Retail Pharmacies

Manufactured In: India

Units Affected: 66,528 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

The recalled products are Ciprofloxacin ophthalmic solution USP, 0.3% as base, packaged in 2.5 mL bottles (NDC 69315-308-02) and 10 mL bottles (NDC 69315-308-10).

Check your medication for lot number 084C040 (Exp 02/28/2026) on 10 mL bottles or lot number 084A024 (Exp 12/31/2025) on 2.5 mL bottles.

If you find that the solution will not come out of the bottle, do not attempt to puncture the nozzle or force the medication out.

If you have health concerns about missed doses, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact FDC Limited for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

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% as base (10 mL)

Variants: 0.3% strength, 10 mL bottle

Lot Numbers:

084C040 (Exp 02/28/2026)

NDC:

69315-308-10

Distributed by Leading Pharma LLC

Product: Ciprofloxacin ophthalmic solution USP, 0.3% as base (2.5 mL)

Variants: 0.3% strength, 2.5 mL bottle

Lot Numbers:

084A024 (Exp 12/31/2025)

NDC:

69315-308-02

Distributed by Leading Pharma LLC