FDC Limited recalls Ciprofloxacin Ophthalmic Solution: Cap stuck in nozzle

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Contact the company & request your remedy

Recalling firmFDC LimitedB-8 MIDC Industrial Area, Waluj District · Aurangabad, Maharashtra State, N/A

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

FDC Limited is recalling 5mL Ciprofloxacin Ophthalmic Solution bottles because the cap spike gets lodged in the nozzle, making it impossible to get the solution out. This affects patients who need this prescription eye drop medication.

Why it’s dangerous

The cap spike gets stuck in the nozzle of the bottle, preventing the solution from being dispensed. This means patients cannot use the medication properly as it's designed for eye drops.

Who’s affected

Patients with a prescription for this eye drop medication are affected. Those who have the specific bottle packaging with the NDC 69315-308-05 lot numbers are most at risk.

How to tell if you have this one

Check for 5mL bottles labeled 'Ciprofloxacin Ophthalmic Solution USP 0.3% Sterile' with NDC 69315-308-05 and lot numbers 083L111 or 084A032.

Brand
FDC Limited
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Bottle Packaging
Look for NDC 69318-308-05 and lot numbers 083L111 or 084A032 on the bottle label.

✎ GovInfoNow

Questions people ask

Is this product safe to use?

No, the cap spike gets stuck in the nozzle, making it impossible to dispense the solution. Do not use this product.

How do I know if I have the recalled product?

Check for 5mL bottles with NDC 69315-308-05 and lot numbers 083L111 or 084A032.

What should I do if I have the recalled product?

The recall does not specify a remedy, so contact your healthcare provider for guidance.

Take action

Contact FDC Limited

We’ve drafted a message you can send FDC Limited to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall D-0182-2025 — FDC Limited FDC Limited

Hello,

I own a FDC Limited that is covered by recall D-0182-2025 from FDC Limited.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0182-2025 (December 16, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0182-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

FDC Limited recalls Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, Sterile, package in 5 mL bottles, Rx Only, Distributed by: Leading

Lower-risk recall