FDA Drug recall D-0282-2025
Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, package in 5 mL bottles, Rx Only, Distributed by: Leading Pharma LLC, Fairfield, NJ. M…
- FDA Drug
- Class II
- ongoing
- Published 2025-03-26
On 2025-03-26 the FDA classified a Class II recall of Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, package in 5 mL bottles, Rx Only, Distributed by: Leading Pharma LLC, Fairfield, NJ. M… by Fdc, citing 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.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0282-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-03-11 |
| Published | 2025-03-26 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Fdc |
| Distribution | US |
Product
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
Reason
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
Identifiers
| ndc | 69315-308-02 |
|---|---|
| ndc | 69315-308-05 |
| ndc | 69315-308-10 |
| code_info | Lot: 084A067, Exp 12/31/2025 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0282-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.