CIPROFLOXACIN OPHTH SOLUTION recall
FDA recall D-0364-2025 · initiated Jan 31, 2025
Direct Rx recalled CIPROFLOXACIN OPHTH SOLUTION in Jan 2025 — an FDA Class II recall (D-0364-2025) because 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.
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
Labelling, packaging or a product mix-up
The wrong information — or the wrong medicine — ended up in the pack. A mix-up is a manufacturing failure that can still be dangerous to swallow.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 477 bottles.
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
Frequently asked
- Was CIPROFLOXACIN OPHTH SOLUTION recalled?
- Direct Rx recalled CIPROFLOXACIN OPHTH SOLUTION in Jan 2025 — an FDA Class II recall (D-0364-2025) because 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. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was CIPROFLOXACIN OPHTH SOLUTION recalled?
- Per the FDA enforcement record, the reason for recall D-0364-2025 was: 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
- Is a recalled CIPROFLOXACIN OPHTH SOLUTION dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of CIPROFLOXACIN OPHTH SOLUTION are affected?
- Distributed: Physicians and medical facilities in 5 states: AL, CA, FL, GA, ID. The recall covers these lots — Lot 11SE2402, Exp Date: 11/30/2025 Lot 14NO2406, Exp Date: 12/31/2025 Lot 29OC2420, Exp Date: 11/30/2025 Lot 30SE2412, Exp Date: 11/30/2025. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0364-2025.