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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Moxifloxacin Ophthalmic Solution Recalled for Failed Impurity Specifications

Agency Publication Date: February 14, 2022
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Summary

Aurobindo Pharma USA Inc. is recalling 115,776 bottles of Moxifloxacin Ophthalmic Solution, USP 0.5% (3 mL). This prescription antibiotic eye drop is being recalled because testing revealed that the product failed to meet standard specifications for impurities or degradation. No incidents or injuries have been reported to date, but patients should consult with a healthcare professional regarding their treatment.

Risk

The presence of impurities or degradation products beyond approved limits can reduce the medication's effectiveness or potentially cause unexpected side effects during use. No injuries have been reported in connection with this specific recall.

What You Should Do

  1. This recall affects sterile Moxifloxacin Ophthalmic Solution, USP 0.5% w/v, packaged in 3 mL bottles (NDC 65862-840-03).
  2. Check the bottle or outer carton for lot numbers CMF210001, CMF210003, or CMF210004, all with an expiration date of June 2023 (6/2023).
  3. If you have health concerns regarding this medication, contact your healthcare provider or pharmacist.
  4. Return any unused product to the place of purchase for a refund, throw it away, or contact Aurobindo Pharma USA Inc. for further instructions.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Moxifloxacin Ophthalmic Solution, USP 0.5% w/v (3 mL bottle)by Aurobindo Pharma USA, Inc.
Variants: 0.5% w/v, 3 mL bottle, Sterile, Rx Only
Lot Numbers:
CMF210001 (Exp 6/2023)
CMF210003 (Exp 6/2023)
CMF210004 (Exp 6/2023)
NDC:
65862-840-03

Distributed by Aurobindo Pharma USA, Inc., East Windsor, NJ 08520.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 89423
Status: Resolved
Manufacturer: Aurobindo Pharma USA Inc.
Sold By: pharmacies
Manufactured In: India, United States
Units Affected: 115776 bottles
Distributed To: Nationwide
Agency Last Updated: August 1, 2023

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.