CLASS II ONGOING Drug recall · Reported 26 Mar 2025 · FDA Enforcement Report
Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, package recalled
FDC is recalling Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, package, distributed nationwide in the US. The recall was initiated on 11 Mar 2025 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-0282-2025
- FDA event ID
- 96495
- Recalling firm
- FDC, Aurangabad, Maharashtra State, N/A
- Brand
- Ciprofloxacin
- Manufacturer
- Leading Pharma, LLC
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 11 Mar 2025
- FDA classified
- 17 Mar 2025
- Reported
- 26 Mar 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Antibiotics
Timeline
| 11 Mar 2025 | Recall initiated by company | |
| 17 Mar 2025 | Classified by FDA | +6 days |
| 26 Mar 2025 | Published in enforcement report | +9 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
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, 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 in the U.S
Questions about this recall
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: 084A067, Exp 12/31/2025
Where was it sold?
Nationwide in the U.S
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 26 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, 0.5%, Sterile recalled by FDCTimolol Maleate | FDC | Other | Nationwide |
| Drug | CLASS II | Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile recalled by FDCTimolol Maleate | FDC | Other | Nationwide |
| Drug | CLASS II | Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile recalled by FDCTimolol Maleate | FDC | Other | NJ |
| Drug | CLASS II | Ciprofloxacin Ophthalmic Solution USP, 0.3% as base recalled by FDCCiprofloxacin | FDC | Packaging Defects | Nationwide |
| Drug | CLASS II | Timolol Maleate Ophthalmic Solution USP, 0.25%, Sterile recalled by FDCTimolol Maleate | FDC | Other | NJ |
Other Ciprofloxacin recalls
All 19| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension recalledCiprofloxacin And Dexamethasone | Sandoz | Temperature Abuse | CA |
| Drug | CLASS II | Ciprofloxacin Ophthalmic Solution USP, 0.3% as base recalled by FDCCiprofloxacin | FDC | Packaging Defects | Nationwide |
| Drug | CLASS II | Ciprofloxacin ophthalmic solution USP, 0.3% as base recalled by FDCCiprofloxacin | FDC | Packaging Defects | Nationwide |
| Drug | CLASS II | Ciprofloxacin Ophthalmic Solution, USP 0.3% (Ciprofloxacin HCl) recalled | Akorn | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Ciprofloxacin Ophthalmic Solution recalled by Mckesson Medical-SurgicalCiprofloxacin Hydrochloride | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |