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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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High RiskFDA Drug
Medications & Supplements/Prescription Drugs

Sun Pharmaceutical Industries, Inc.: BromSite Ophthalmic Solution Recalled Due to Lack of Sterility Assurance

Agency Publication Date: January 30, 2019
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Summary

Sun Pharmaceutical Industries, Inc. is recalling 69,840 bottles of BromSite (bromfenac ophthalmic solution) 0.075%, a prescription eye drop used to treat inflammation. The recall was initiated because the product may lack sterility assurance, meaning the medicine inside the bottle could be contaminated with microorganisms. While no specific injuries or infections have been reported in this notice, using non-sterile eye drops can lead to serious eye infections.

Risk

If an eye drop is not sterile, it can introduce bacteria or other contaminants directly into the eye, potentially causing sight-threatening infections or severe inflammation. Because these drops are often used after eye surgery, the risk of a serious complication from a non-sterile product is significantly higher.

What You Should Do

  1. Check your BromSite (bromfenac ophthalmic solution) 0.075%, 5 mL bottle for the NDC number 49708-754-41 and lot number V18E01 with an expiration date of 05/2020.
  2. If you identify an affected bottle, stop using the medication immediately to avoid the risk of infection.
  3. Contact your healthcare provider or pharmacist for guidance on a replacement prescription or alternative treatment.
  4. Return any unused product to your pharmacy for a refund and contact Sun Pharmaceutical Industries, Inc. at 1-800-406-7984 for further instructions.
  5. For additional information, 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

Contact healthcare provider and return product

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

Affected Products

Product: BromSite (bromfenac ophthalmic solution) 0.075% (5 mL)
Model:
NDC 49708-754-41
Lot Numbers:
V18E01 (Exp. 05/2020)
Date Ranges: Expiration 05/2020

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 81958
Status: Resolved
Manufacturer: Sun Pharmaceutical Industries, Inc.
Sold By: Pharmacies
Manufactured In: United States
Units Affected: 69840 bottles
Distributed To: Nationwide

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.