Lupin Pharmaceuticals Inc. recalls Moxifloxacin Ophthalmic Solution USP, 0.5%, 5 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals Inc.
Lupin Pharmaceuticals recalls 0.5% moxifloxacin eye drops due to impurities detected in stability testing. Affected lots may cause eye injury if used. Contact for return instructions.
Lower-risk recall
Failed Impurities/Degradation Specifications: An out-of-specification result in the related substance test during three month long-term stability study.
Contact the company & request your remedy
What happened, in plain English
Lupin Pharmaceuticals is recalling a specific eye drop product because testing found impurities that could cause eye injury. This recall affects people who have the 5 mL bottle with the lot number H800393. Read more at govinfonow.com/recall/39844-lupin-moxifloxacin-eye-drops-recall-impurities-risk-eye-injury.
Source Summary by GovInfoNow · govinfonow.com/recall/39844-lupin-moxifloxacin-eye-drops-recall-impurities-risk-eye-injury · Updated October 6, 2026 · FDA enforcement record: FDA #D-1050-2018
Cite this page
“Lupin Moxifloxacin Eye Drops Recall: Impurities Risk Eye Injury.” GovInfoNow, updated October 6, 2026. https://govinfonow.com/recall/39844-lupin-moxifloxacin-eye-drops-recall-impurities-risk-eye-injury. Based on FDA recall #D-1050-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1050-2018%22&limit=1).
Why it’s dangerous
The eye drops failed stability testing, showing impurities that could cause eye injury if used. This happened during a three-month test, meaning the product may not be safe over time.
Who’s affected
People with a prescription for the 0.5% moxifloxacin eye drops (5 mL bottle) from Lupin Pharmaceuticals. Those who have the lot number H800393 are most at risk.
How to tell if you have this one
Check for the 5 mL bottle labeled 'Moxifloxacin Ophthalmic Solution USP 0.5%', with lot number H800393. The product was manufactured in Baltimore, Maryland and expires January 2020.
- Brand
Lupin Pharmaceuticals- Category
Drug
What to do — step by step
Check Product Details
Look for the 5 mL bottle with lot number H800393 on the label.
Questions people ask
Is this product safe to use?
The recall indicates impurities detected in stability testing, so it is not safe to use. The product should be returned.
How do I know if I have the recalled product?
Check for the 5 mL bottle labeled 'Moxifloxacin Ophthalmic Solution USP 0.5%' with lot number H800393.
What should I do if I have this product?
The recall does not specify a remedy, so contact Lupin Pharmaceuticals for 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-1050-2018 — Lupin Pharmaceuticals Lupin Pharmaceuticals Hello, I own a Lupin Pharmaceuticals that is covered by recall D-1050-2018 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.
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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-1050-2018 (July 26, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1050-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 6, 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.