Aurobindo Pharma Moxifloxacin Ophthalmic Solution Recall

Why it was recalled

Failed Impurities/Degradation Specifications

Product description

Moxifloxacin Ophthalmic Solution, USP 0.5% w/v, 3 mL bottle, Sterile, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, Made in India, NDC 65862-840-03

Lot numbers, UPCs & expiration codes

Lot#: CMF210001, CMF210003, CMF210004, Exp 6/2023

Where it was sold

USA Nationwide

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-0560-2022
Classification: Class II
Status: Terminated
Recall initiated: Jan 14, 2022
FDA report date: Feb 23, 2022
Quantity: 115776 bottles
Recall type: Voluntary: Firm initiated
Recalling firm: Aurobindo Pharma USA Inc.

Original FDA data

Every field from FDA enforcement report D-0560-2022, exactly as published.

Show all FDA fields

City: East Windsor
State: NJ
Status: Terminated
Country: United States
Event ID: 89423
Address: 279 Princeton Hightstown Rd
Code information: Lot#: CMF210001, CMF210003, CMF210004, Exp 6/2023
Postal code: 08520-1401
Report date: Feb 23, 2022
Product type: Drugs
Recall number: D-0560-2022
Classification: Class II
Recalling firm: Aurobindo Pharma USA Inc.
Product quantity: 115776 bottles
Termination date: Jul 31, 2024
Reason for recall: Failed Impurities/Degradation Specifications
Voluntary / mandated: Voluntary: Firm initiated
Product description: Moxifloxacin Ophthalmic Solution, USP 0.5% w/v, 3 mL bottle, Sterile, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, Made in India, NDC 65862-840-03
Distribution pattern: USA Nationwide
Recall initiation date: Jan 14, 2022
Initial firm notification: Letter
Center classification date: Feb 14, 2022

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0560-2022, published Feb 23, 2022. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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