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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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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Lupin Pharmaceuticals Inc.: Moxifloxacin Ophthalmic Solution Recalled for Failed Impurity Specifications

Agency Publication Date: August 1, 2018
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Summary

Lupin Pharmaceuticals Inc. has recalled 13,896 bottles of Moxifloxacin Ophthalmic Solution USP, 0.5% (generic Vigamox), a prescription antibiotic eye drop used to treat bacterial infections. The recall was initiated because long-term stability testing showed the medicine exceeded allowed levels for impurities and degradation products after three months of storage. Consumers who have this medication should contact their doctor or pharmacist for guidance on continuing treatment with a different batch.

Risk

The presence of impurities or degradation products that exceed safety specifications can reduce the effectiveness of the antibiotic and potentially cause irritation or other adverse reactions when applied to the eye.

What You Should Do

  1. Check your prescription bottle of Moxifloxacin Ophthalmic Solution USP, 0.5% (5 mL bottle) for NDC 68180-422-01.
  2. Locate the lot number and expiration date printed on the bottle; this recall specifically affects Lot H800393 with an expiration date of 01/2020.
  3. Contact your healthcare provider or pharmacist immediately to discuss your treatment and obtain a replacement prescription if you have the affected lot.
  4. Return any unused product from the affected lot to your pharmacy for a refund and further instructions.
  5. Contact Lupin Pharmaceuticals Inc. at their Baltimore headquarters or through your dispensing pharmacy if you have additional questions regarding this voluntary recall.
  6. For further consumer safety questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Drug Recall Refund/Guidance

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Moxifloxacin Ophthalmic Solution USP, 0.5% (5 mL bottle)
Model:
NDC 68180-422-01
Recall #: D-1050-2018
Lot Numbers:
H800393 (Exp. 01/2020)
Date Ranges: Expiration 01/2020

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 80668
Status: Resolved
Manufacturer: Lupin Pharmaceuticals Inc.
Sold By: Pharmacies
Manufactured In: India, United States
Units Affected: 13,896 bottles
Distributed To: Nationwide
Agency Last Updated: August 27, 2018

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.