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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 Being Subpotent

Agency Publication Date: February 26, 2021
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Summary

SUN PHARMACEUTICAL INDUSTRIES INC is recalling 37,400 cartons of Cequa (cyclosporine ophthalmic solution) 0.09%, a prescription eye drop used to treat dry eyes. The recall was initiated because the medication was found to be subpotent, meaning it may not contain the full strength of the active ingredient required to effectively treat your condition. This recall affects the 60-count boxes of single-use vials, specifically Lot 10007 with an expiration date of January 2022.

Risk

A subpotent drug may result in decreased effectiveness of the treatment. If the medication does not provide the intended therapeutic dose, the patient's dry eye symptoms may not be properly managed, potentially leading to continued discomfort or eye irritation.

What You Should Do

  1. Check your Cequa (cyclosporine ophthalmic solution) 0.09% packaging for Lot 10007 and an expiration date of 01/2022. The lot information is located on the carton of 60 single-use vials (NDC 47335-506-96).
  2. Contact your healthcare provider or pharmacist immediately to discuss if you have been using the affected medication and to obtain a replacement prescription.
  3. Return any unused vials or cartons from Lot 10007 to your pharmacy for a refund and contact Sun Pharmaceutical Industries Inc for further instructions regarding the return process.
  4. Contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional questions.

Your Remedy Options

💰Full Refund

Contact healthcare provider or pharmacist and return for 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 (6 pouches x 10 single-use vials (0.25 mL each))
Model:
NDC 47335-506-96
Lot Numbers:
10007 (Exp 01/2022)
Date Ranges: Exp 01/2022

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 87349
Status: Resolved
Manufacturer: SUN PHARMACEUTICAL INDUSTRIES INC
Sold By: Pharmacies
Manufactured In: France, United States
Units Affected: 37,400 cartons/60 vials per carton
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.