Class IIOngoing

Ciprofloxacin Ophthalmic Solution USP recall

FDA recall D-0282-2025 · initiated Mar 11, 2025

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was 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

Details

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
Recalling company: Fdc Ltd
Classification: Class II
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: Nationwide in the U.S
Initiated: Mar 11, 2025
FDA report date: Mar 26, 2025

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0282-2025 ↗

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