Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Gatifloxacin Ophthalmic Solution Recalled by Lupin Pharmaceuticals Inc. Due to Failed Stability Specifications: Out-of-specification results observed in a...
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 Lupin Pharmaceuticals Inc. directly.
Affected Products
Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 68180-435-01.
Quantity: 50,832 bottles
Why Was This Recalled?
Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Lupin Pharmaceuticals Inc.
Lupin Pharmaceuticals Inc. has 119 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report