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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: February 8, 2019
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Summary

Lupin Pharmaceuticals is recalling 43,860 bottles of Moxifloxacin Ophthalmic Solution USP, 0.5% (3 mL), a prescription antibiotic eye drop used to treat bacterial infections. The recall was initiated because long-term stability testing showed the product did not meet purity and degradation specifications at the three-month mark. This means the medication may contain higher levels of impurities than allowed by safety standards. Consumers should contact their healthcare provider or pharmacist regarding the continued use of this product and return any remaining medication to their pharmacy.

Risk

The presence of impurities or degradation products beyond specified limits can reduce the effectiveness of the antibiotic treatment or potentially cause unexpected irritation or adverse reactions in the eye.

What You Should Do

  1. Check your prescription bottle for 'Moxifloxacin Ophthalmic Solution USP, 0.5%, 3 mL' with NDC 68180-422-01.
  2. Verify if your bottle belongs to one of the affected lot numbers and expiration dates: Lot H705562 or H705563 with expiration date 11/2019, or Lot H800616 with expiration date 01/2020.
  3. Contact your healthcare provider or pharmacist immediately for guidance on whether you should continue using the medication or switch to a different supply.
  4. Return any unused product from these specific lots to the pharmacy where you purchased it for a refund.
  5. Contact Lupin Pharmaceuticals at 1-888-723-3332 or visit www.fda.gov/safety/recalls for more information regarding this recall.
  6. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

๐Ÿ’ฐFull Refund

Drug Recall Remedy

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% (3 mL dropper bottle)
Model:
NDC 68180-422-01
Recall #: D-0484-2019
Lot Numbers:
H705562 (Exp. 11/2019)
H705563 (Exp. 11/2019)
H800616 (Exp. 01/2020)
Date Ranges: Expiration 11/2019, Expiration 01/2020

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 82037
Status: Resolved
Manufacturer: Lupin Pharmaceuticals Inc.
Sold By: wholesalers; drug chains; mail order pharmacies; supermarkets
Manufactured In: United States, India
Units Affected: 43,860 3ml bottles
Distributed To: Nationwide

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.