Actavis Levofloxacin Eye Drops Recall: Impurities Risk Eye Injury
Actavis recalls 0.5% Levofloxacin Ophthalmic Solution bottles with impurities that could cause eye injury. Return or stop using affected lots.
Use caution until it’s fixed
Failed Impurities/ Degradation Specifications: OOS for related compound (levofloxacin n-oxide) at the 18 month stability time point.
Contact the company
What happened, in plain English
Actavis is recalling 0.5% Levofloxacin Ophthalmic Solution eye drops due to impurities that may cause eye injury. This recall affects specific lots manufactured by Hi-Tech Pharmacal. Read more at govinfonow.com/recall/42045-actavis-levofloxacin-eye-drops-recall-impurities-risk-eye-injury.
Source Summary by GovInfoNow · govinfonow.com/recall/42045-actavis-levofloxacin-eye-drops-recall-impurities-risk-eye-injury · Updated October 8, 2026 · FDA enforcement record: FDA #D-0514-2017
Cite this page
“Actavis Levofloxacin Eye Drops Recall: Impurities Risk Eye Injury.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/42045-actavis-levofloxacin-eye-drops-recall-impurities-risk-eye-injury. Based on FDA recall #D-0514-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0514-2017%22&limit=1).
Why it’s dangerous
The eye drops contain impurities that could cause eye injury if used. The impurities were detected at the 18-month stability point, meaning the product may degrade over time.
Who’s affected
People with prescriptions for this eye drop medication are affected. Those using the recalled lots are most at risk.
How to tell if you have this one
Check for the product name 'Levofloxacin Ophthalmic Solution, 0.5%, Sterile, 5mL bottles'. Look for lot numbers 348748 (exp 11/30/2017), 350578 (exp 3/31/2018), or 633467 (exp 3/31/2017).
- Brand
Actavis- Category
Drug
What to do — step by step
Check Product Lot Number
Look for lot numbers 348748, 350578, or 633467 on the bottle.
Stop Using if Affected
If you have the recalled lot numbers, stop using the eye drops immediately.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 11 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0514-2017 (February 7, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0514-2017 to see it in context.
- Plain-language summary written by qwen3:4b on October 8, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.