Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Gatifloxacin Ophthalmic Solution 0.5% Recalled by Mylan Pharmaceuticals Inc. Due to Failed Impurities/Degradation Specifications:OOS for unknown impurity.
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Mylan Pharmaceuticals Inc. directly.
Affected Products
Gatifloxacin Ophthalmic Solution 0.5%, 2.5 mL per bottle, Rx Only, Mfd. for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505. Made in India. NDC: 0378-5431-35
Quantity: 13,157 5 mL bottles
Why Was This Recalled?
Failed Impurities/Degradation Specifications:OOS for unknown impurity.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Mylan Pharmaceuticals Inc.
Mylan Pharmaceuticals Inc. has 71 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report