Class IIOngoing

CIPROFLOXACIN OPHTH SOLUTION recall

FDA recall D-0364-2025 · initiated Jan 31, 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 OPHTH SOLUTION, 0.3% 5mL bottle, Rx Only, Generic for CILOXAN, Packaged and Distributed by: DIRECT Rx, NDC 61919-795-05.
Recalling company: Direct Rx
Classification: Class II
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: Physicians and medical facilities in 5 states: AL, CA, FL, GA, ID
Initiated: Jan 31, 2025
FDA report date: Apr 23, 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-0364-2025 ↗

← All drug recalls