Mylan Pharmaceuticals Inc. recalls Gatifloxacin Ophthalmic Solution 0.5%, 2.5 mL per bottle, Rx Only, Mfd. for: Mylan Pharmaceuticals Inc., Morgantown, WV
Mylan recalls Gatifloxacin Ophthalmic Solution 0.5% due to failed impurities. This medication may contain an unknown impurity that could pose risks. Consumers should contact Mylan for details.
Recall notice
Failed Impurities/Degradation Specifications:OOS for unknown impurity.
Contact the company & request your remedy
What happened, in plain English
Mylan is recalling Gatifloxacin Ophthalmic Solution 0.5% (2.5 mL bottles) because it failed impurities tests. This could mean the medication contains an unknown impurity that might be harmful if used. Read more at govinfonow.com/recall/38019-mylan-gatifloxacin-ophthalmic-solution-recall-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/38019-mylan-gatifloxacin-ophthalmic-solution-recall-impurity-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-1848-2019
Cite this page
“Mylan Gatifloxacin Ophthalmic Solution Recall: Impurity Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/38019-mylan-gatifloxacin-ophthalmic-solution-recall-impurity-risk. Based on FDA recall #D-1848-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1848-2019%22&limit=1).
Why it’s dangerous
The medication failed impurities tests, showing an unknown impurity that could be harmful. This means the eye drop might contain a substance that could cause injury if used improperly.
Who’s affected
People with a prescription for this eye drop medication are affected. Those who have the specific lot number or batch from India are at higher risk.
How to tell if you have this one
Check for the product name 'Gatifloxacin Ophthalmic Solution 0.5%'. Look for the lot number GABH0003 and expiration date 7/2020 on the bottle.
- Brand
Mylan- Category
Drug
What to do — step by step
Check Product Details
Look for the lot number GABH0003 and expiration date 7/2020 on the bottle.
Questions people ask
Is this medication safe to use?
The recall states the medication failed impurities tests, but the exact risk is unknown. Do not use until Mylan provides further details.
What should I do if I have this medication?
Check the lot number and expiration date. If it matches GABH0003 with expiration 7/2020, contact Mylan for instructions.
How can I get a replacement?
The recall record does not mention a remedy or replacement process. Contact Mylan directly for assistance.
Contact Mylan
We’ve drafted a message you can send Mylan to request your refund or repair — edit it as you like.
Subject: Recall D-1848-2019 — Mylan Mylan Hello, I own a Mylan that is covered by recall D-1848-2019 from Mylan. 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-1848-2019 (September 6, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1848-2019 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.