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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

SUN PHARMACEUTICAL INDUSTRIES INC: Cequa (cyclosporine ophthalmic solution) Recalled for Subpotency and Particles

Agency Publication Date: May 20, 2021
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Summary

Sun Pharmaceutical Industries Inc. is recalling two lots of Cequa (cyclosporine ophthalmic solution) 0.09%, which is used to treat chronic dry eye. The medication is being recalled because it may be subpotent, meaning it is not as strong as it should be, and because visible particles were found in the solution. You can identify the affected products by checking for NDC 47335-506-96 and specific lot numbers 10006 and 10009 on the packaging of the 60 single-use vial boxes.

Risk

A subpotent medication may not effectively treat your dry eye condition as intended by your doctor. Additionally, the presence of particles in an eye solution can cause irritation or injury to the surface of the eye upon application.

What You Should Do

  1. Check your medication packaging for Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (NDC 47335-506-96).
  2. Look for lot number 10006 with an expiration date of January 2022 (01/2022) or lot number 10009 with an expiration date of March 2022 (03/2022).
  3. If your medication matches these lot numbers, contact your healthcare provider or pharmacist for guidance on how to continue your treatment and return any unused vials to the pharmacy for a refund.
  4. Contact Sun Pharmaceutical Industries Inc. at 1-800-406-7984 for further instructions regarding this recall.
  5. For additional questions, call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

💰Full Refund

Healthcare guidance and refund

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

Affected Products

Product: Cequa (cyclosporine ophthalmic solution) 0.09% (60 Single-Use Vials)
Model:
NDC 47335-506-96
Lot Numbers:
10006 (Exp. 01/2022)
10009 (Exp. 03/2022)
Date Ranges: Expiration date 01/2022, Expiration date 03/2022

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 87922
Status: Resolved
Manufacturer: SUN PHARMACEUTICAL INDUSTRIES INC
Sold By: Pharmacies
Manufactured In: France, United States
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 · 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.