Lupin Pharmaceuticals Inc. recalls Gatifloxacin Ophthalmic Solution 0.5%, For Use in the Eyes Only, Rx Only, Sterile, 2.5 mL Bottle, Manufactured for:
Lupin Pharmaceuticals recalls 2.5mL Gatifloxacin eye drops due to missing labels. Product complaints report missing bottle labels. Consumers should check for label issues before use.
Lower-risk recall
Labeling: Missing label; Product complaints reported missing bottle label.
Contact the company & request your remedy
What happened, in plain English
Lupin Pharmaceuticals is recalling Gatifloxacin Ophthalmic Solution 2.5mL bottles because they have missing labels. This could lead to incorrect use if the label is not present, but the recall does not mention any injuries or immediate safety risks. Read more at govinfonow.com/recall/38328-lupin-gatifloxacin-eye-drops-recall-missing-label-hazard.
Source Summary by GovInfoNow · govinfonow.com/recall/38328-lupin-gatifloxacin-eye-drops-recall-missing-label-hazard · Updated October 5, 2026 · FDA enforcement record: FDA #D-1490-2019
Cite this page
“Lupin Gatifloxacin Eye Drops Recall: Missing Label Hazard.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/38328-lupin-gatifloxacin-eye-drops-recall-missing-label-hazard. Based on FDA recall #D-1490-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1490-2019%22&limit=1).
Why it’s dangerous
The missing label means the bottle may not be correctly identified as a prescription eye drop. This could lead to incorrect use if the label is not present, but the recall does not mention any injuries or immediate safety risks.
Who’s affected
People who have the 2.5mL Gatifloxacin eye drop bottles with the missing label. Those using prescription eye drops for eye conditions are most at risk if the label is missing.
How to tell if you have this one
Check for the missing label on the bottle. The product is a 2.5mL bottle of Gatifloxacin Ophthalmic Solution 0.5% for eye use only, manufactured by Lupin Pharmaceuticals.
- Brand
Lupin Pharmaceuticals- Category
Drug
What to do — step by step
Check Label
Look for the missing label on the bottle. If the label is missing, stop using the product.
Questions people ask
Is this product safe to use if the label is missing?
The recall states that missing labels have been reported, but it does not specify if the product is safe to use without the label.
How can I tell if I have the recalled product?
Check for the missing label on the 2.5mL Gatifloxacin Ophthalmic Solution 0.5% bottle manufactured by Lupin Pharmaceuticals.
What should I do if I have the missing label?
The recall does not specify a remedy for missing labels, so check with the manufacturer for further instructions.
Contact Lupin Pharmaceuticals
We’ve drafted a message you can send Lupin Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-1490-2019 — Lupin Pharmaceuticals Lupin Pharmaceuticals Hello, I own a Lupin Pharmaceuticals that is covered by recall D-1490-2019 from Lupin Pharmaceuticals. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Similar recalls
Keep exploring
From people who’ve dealt with this
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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-1490-2019 (July 11, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1490-2019 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 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.