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Drug recall · FDA · Published February 1, 2019

Lupin Pharmaceuticals Inc. recalls Moxifloxacin Ophthalmic Solution USP, 0.5%, 3 mL dropper 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 from 2019-2020 may cause eye injury if used.

🇺🇸 FDA recall #D-0484-2019DrugLupin Pharmaceuticals ›
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Contact the company & request your remedy

Recalling firmLupin Pharmaceuticals Inc.111 S Calvert St Fl 21ST, N/A · Baltimore, MD 21202-6174
No email on file for this recall — reach the company by phone or its official page instead.No email on file — write to the address above instead.
✎ GovInfoNow plain-language explainer

What happened, in plain English

Lupin Pharmaceuticals is recalling certain moxifloxacin eye drops because tests found impurities that could harm your eyes. This recall affects patients who have been prescribed these drops with specific lot numbers and expiration dates. Read more at govinfonow.com/recall/39219-lupin-moxifloxacin-eye-drops-recall-impurities-risk-eye-injury.

Source Summary by GovInfoNow · govinfonow.com/recall/39219-lupin-moxifloxacin-eye-drops-recall-impurities-risk-eye-injury · Updated October 5, 2026 · FDA enforcement record: FDA #D-0484-2019

Cite this page

“Lupin Moxifloxacin Eye Drops Recall: Impurities Risk Eye Injury.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/39219-lupin-moxifloxacin-eye-drops-recall-impurities-risk-eye-injury. Based on FDA recall #D-0484-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0484-2019%22&limit=1).

Why it’s dangerous

The eye drops failed stability testing, showing impurities that could potentially cause eye injury if used. This issue was detected during a long-term stability study where the product was supposed to remain safe over time.

Who’s affected

Patients prescribed the recalled moxifloxacin eye drops by a doctor. Those with the specific lot numbers (H705562, H705563) or expiration dates (11/2019, 01/2020) are most at risk.

How to tell if you have this one

Check the product label for the lot number (H705562 or H705563) and expiration date (11/2019 or 01/2020). The product is a 3 mL dropper bottle with a prescription label.

  • Brand
    Lupin Pharmaceuticals
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Look for the lot number (H705562 or H705563) and expiration date (11/2019 or 01/2020) on the bottle.

✎ GovInfoNow

Questions people ask

Why is this product being recalled?

The product failed stability testing, showing impurities that could cause eye injury if used.

What should I do if I have this product?

Check the lot number and expiration date. If it matches the recalled lots, contact your doctor for a replacement.

Is there a fix for this issue?

The recall does not include a fix; affected patients should get a new prescription from their doctor.

Take action

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-0484-2019 — Lupin Pharmaceuticals Lupin Pharmaceuticals

Hello,

I own a Lupin Pharmaceuticals that is covered by recall D-0484-2019 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.

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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-0484-2019 (February 1, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0484-2019 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA