Lupin Pharmaceuticals Inc. recalls Moxifloxacin Ophthalmic Solution USP, 0.5%, 3 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454
Lupin Pharmaceuticals recalls certain moxifloxacin eye drops due to impurities. Affected lots from July 2018 to December 2020 may pose health risks. Consumers should check product details and contact Lupin for guidance.
Lower-risk recall
Failed Impurities/Degradation Specifications: Expansion of July 2018 and February 2019 recall due to high out-of-specification for impurities.
Contact the company & request your remedy
What happened, in plain English
Lupin Pharmaceuticals is recalling specific batches of moxifloxacin eye drops (0.5% solution) because they contain impurities that could be harmful. This recall follows previous issues with the product's quality specifications. Read more at govinfonow.com/recall/39151-lupin-moxifloxacin-eye-drops-recall-impurities-may-cause-harm.
Source Summary by GovInfoNow · govinfonow.com/recall/39151-lupin-moxifloxacin-eye-drops-recall-impurities-may-cause-harm · Updated October 5, 2026 · FDA enforcement record: FDA #D-0517-2019
Cite this page
“Lupin Moxifloxacin Eye Drops Recall: Impurities May Cause Harm.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/39151-lupin-moxifloxacin-eye-drops-recall-impurities-may-cause-harm. Based on FDA recall #D-0517-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0517-2019%22&limit=1).
Why it’s dangerous
The eye drops contain impurities that exceed safe levels, which could potentially cause harm if used. This issue was detected through quality testing and led to multiple recalls over time.
Who’s affected
Prescription eye drop users who purchased the recalled batches from July 2018 to December 2020. People with eye conditions requiring moxifloxacin are most at risk.
How to tell if you have this one
Check the product label for the batch number (e.g., H701618) and expiration date. The product is a 3 mL bottle of moxifloxacin ophthalmic solution, 0.5%, prescription-only, with NDC 68180-422-01.
- Brand
Lupin- Category
Drug
What to do — step by step
Check Product Details
Look for the batch number and expiration date on the label to determine if the product is recalled.
Questions people ask
Why is this product being recalled?
The product contains impurities that exceed safe levels, which was detected through quality testing and led to multiple recalls.
How can I tell if I have the recalled product?
Check the product label for the batch number (e.g., H701618) and expiration date. The product is a 3 mL bottle of moxifloxacin ophthalmic solution, 0.5%, prescription-only, with NDC 68180-422-01.
What should I do if I have the recalled product?
The recall does not specify a remedy, so contact Lupin Pharmaceuticals for guidance.
Contact Lupin
We’ve drafted a message you can send Lupin to request your refund or repair — edit it as you like.
Subject: Recall D-0517-2019 — Lupin Lupin Hello, I own a Lupin that is covered by recall D-0517-2019 from Lupin. 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-0517-2019 (February 26, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0517-2019 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.