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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.: Gatifloxacin Ophthalmic Solution Recalled Due to Missing Bottle Labels

Agency Publication Date: July 16, 2019
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Summary

Lupin Pharmaceuticals Inc. has recalled 17,238 bottles of Gatifloxacin Ophthalmic Solution 0.5% because some bottles were distributed without any labeling. This prescription eye medication is used to treat bacterial infections in the eye and was sold in 2.5 mL sterile bottles nationwide across the United States and Puerto Rico. The recall specifically affects product lot H805157 with an expiration date of May 2020. Consumers should immediately check their medication to ensure the bottle is properly labeled to prevent misuse.

Risk

A missing label prevents patients from identifying the drug, understanding dosage instructions, or knowing the expiration date, which could lead to using the wrong medication or an ineffective treatment. Using an unidentified medication for an eye infection poses a significant risk of delayed recovery or potential adverse reactions if the product is confused with other eye drops.

What You Should Do

  1. Check your Gatifloxacin Ophthalmic Solution 0.5% (2.5 mL bottle) to see if it has a label attached to the bottle itself.
  2. Verify if your medication belongs to Lot H805157 with an expiration date of May 2020 (Exp. 05/2020) and NDC 68180-435-01.
  3. If you find a bottle that is missing its label, or if you are unsure if you have the correct medication, do not use the product.
  4. Contact your healthcare provider or pharmacist immediately for guidance on how to manage your condition if your medication is part of this recall.
  5. Return any unlabeled or affected product to the pharmacy where you purchased it for a refund and contact Lupin Pharmaceuticals Inc. for further instructions.
  6. For additional 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

Healthcare consultation and pharmacy refund

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

Affected Products

Product: Gatifloxacin Ophthalmic Solution 0.5% (2.5 mL Bottle)
Model:
NDC 68180-435-01
Recall #: D-1490-2019
Lot Numbers:
H805157 (Exp. 05/2020)
Date Ranges: Expiration Date: 05/2020

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 83333
Status: Resolved
Manufacturer: Lupin Pharmaceuticals Inc.
Sold By: pharmacies
Manufactured In: India, United States
Units Affected: 17,238 bottles
Distributed To: Nationwide
Agency Last Updated: July 17, 2019

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.