Class III — Low Risk

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: Out of specification test results...

Date: February 1, 2019
Company: Lupin Pharmaceuticals Inc.
Status: Terminated
Source: FDA (Drug)

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%, 3 mL dropper bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 Manufactured by: lupin Limited Pithampur (M.P.) 454 775 India. NDC 68180-422-01

Quantity: 43,860 3ml bottles

Why Was This Recalled?

Failed Impurities/Degradation Specifications: Out of specification test results in related substance at three-month long term stability study was obtained.

Where Was This Sold?

Product was distributed by 5 wholesalers, 6 drug chains, 4 mail order pharmacies and 1 mail order pharmacy/supermarket who may have further distribute the product 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