CLASS II ONGOING Drug recall · Reported 15 Jan 2025 · FDA Enforcement Report
Ciprofloxacin Ophthalmic Solution USP, 3% as base, Sterile, package recalled
FDC is recalling Ciprofloxacin Ophthalmic Solution USP, 3% as base, Sterile, package, distributed nationwide in the US. The recall was initiated on 16 Dec 2024 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0182-2025
- FDA event ID
- 96014
- Recalling firm
- FDC, Aurangabad, Maharashtra State
- Brand
- Ciprofloxacin
- Manufacturer
- Leading Pharma, LLC
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 16 Dec 2024
- FDA classified
- 3 Jan 2025
- Reported
- 15 Jan 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Antibiotics
Timeline
| 16 Dec 2024 | Recall initiated by company | |
| 3 Jan 2025 | Classified by FDA | +18 days |
| 15 Jan 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Defective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, Sterile, package in 5 mL bottles, Rx Only, Distributed by: Leading Pharma LLC, Fairfield, NJ. Manufactured by: FDC Limited, Maharashtra, India, NDC 69315-308-05
Where it was distributed
Nationwide
Questions about this recall
Is Ciprofloxacin Ophthalmic Solution USP, 3% as base, Sterile, package recalled?
Yes. FDC recalled Ciprofloxacin Ophthalmic Solution USP, 3% as base, Sterile, package on 16 Dec 2024. The recall is Class II and its status is Ongoing. Recall number D-0182-2025.
Why was it recalled?
Defective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
Which lots are affected?
Lot: 083L111, Exp. 11/30/2025; 084A032, Exp. 12/31/2025
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from FDC
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Timolol Maleate Ophthalmic Solution USP, 5%, Sterile recalled by FDCTimolol Maleate | FDC | Sterility | Nationwide |
| Drug | CLASS II | Timolol Maleate Ophthalmic Solution USP, 5%, Sterile recalled by FDCTimolol Maleate | FDC | Sterility | Nationwide |
| Drug | CLASS II | Ciprofloxacin Ophthalmic Solution USP, 3% as base, package recalledCiprofloxacin | FDC | Packaging Defects | Nationwide |
| Drug | CLASS II | Timolol Maleate Ophthalmic Solution USP, 5%, Sterile recalled by FDCTimolol Maleate | FDC | Sterility | NJ |
| Drug | CLASS II | Timolol Maleate Ophthalmic Solution USP, 25%, Sterile recalled by FDCTimolol Maleate | FDC | Sterility | NJ |
Other Ciprofloxacin recalls
All 13| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Ciprofloxacin 3% and Dexamethasone 1% Otic Suspension recalled by SandozCiprofloxacin And Dexamethasone | Sandoz | Temperature Abuse | CA |
| Drug | CLASS II | Ciprofloxacin Ophthalmic Solution USP, 3% as base, package recalledCiprofloxacin | FDC | Packaging Defects | Nationwide |
| Drug | CLASS II | Ciprofloxacin ophthalmic solution USP, 3% as base recalled by FDCCiprofloxacin | FDC | Packaging Defects | Nationwide |
| Drug | CLASS II | Ciprofloxacin Ophthalmic Solution recalled by Mckesson Medical-SurgicalCiprofloxacin Hydrochloride | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Altaire Ciprofloxacin Ophthalmic Solution recalledCiprofloxacin Hcl Ophthalmic | Altaire Pharmaceuticals | Sterility | Nationwide |