Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Moxifloxacin Ophthalmic Solution USP Recalled by Lupin Pharmaceuticals Inc. Due to Failed Impurities/Degradation Specifications: An out-of-specification result in the...
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
Moxifloxacin Ophthalmic Solution USP, 0.5%, 5 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775, INDIA, NDC 68180-422-01
Quantity: 13,896 bottles
Why Was This Recalled?
Failed Impurities/Degradation Specifications: An out-of-specification result in the related substance test during three month long-term stability study.
Where Was This Sold?
Product was distributed throughout the United 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