SUN PHARMACEUTICAL INDUSTRIES INC recalls Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouches x 10 single-use vials (0.25 mL each)),
Sun Pharma recalls Cequa (cyclosporine ophthalmic solution) 0.09% due to subpotent risk. This medication is for prescription use only and may not be as effective as intended.
Lower-risk recall
Subpotent
Contact the company & request your remedy
What happened, in plain English
Sun Pharma is recalling Cequa (cyclosporine ophthalmic solution) 0.09% because it may not be as effective as intended. This recall affects prescription-only medication that could lead to reduced treatment efficacy. Read more at govinfonow.com/recall/36500-sun-pharma-cequa-ophthalmic-solution-0-09-recall-subpotent-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/36500-sun-pharma-cequa-ophthalmic-solution-0-09-recall-subpotent-risk · Updated October 4, 2026 · FDA enforcement record: FDA #D-0289-2021
Cite this page
“Sun Pharma Cequa Ophthalmic Solution 0.09% Recall: Subpotent Risk.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36500-sun-pharma-cequa-ophthalmic-solution-0-09-recall-subpotent-risk. Based on FDA recall #D-0289-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0289-2021%22&limit=1).
Why it’s dangerous
Subpotent means the medication may not contain enough active ingredient to be effective. This could result in reduced treatment efficacy for patients using it for eye conditions.
Who’s affected
Prescription patients using Cequa for eye conditions. Those with specific medical conditions requiring precise dosing may be at higher risk.
How to tell if you have this one
Check for Cequa (cyclosporine ophthalmic solution) 0.09% 60 single-use vials (6 pouches x 10 vials). The product was manufactured by Laboratoire Unither in France with NDC 47335-506-96 and lot 10007, expiring 01/2022.
- Brand
Sun Pharma- Category
Drug
What to do — step by step
Check Product Details
Verify the product label for Cequa 0.09% 60 single-use vials with NDC 47335-506-96 and lot 10007.
Questions people ask
Is this product safe to use?
The recall is due to subpotent risk, meaning it may not be as effective as intended. It is not unsafe but could lead to reduced treatment efficacy.
What should I do if I have this product?
The recall does not specify a remedy, so check with your healthcare provider for guidance on whether to continue using it.
How can I confirm if I have the recalled product?
Look for the NDC code 47335-506-96 and lot number 10007 on the product label.
Contact Sun Pharma
We’ve drafted a message you can send Sun Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-0289-2021 — Sun Pharma Sun Pharma Hello, I own a Sun Pharma that is covered by recall D-0289-2021 from Sun Pharma. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0289-2021 (February 22, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0289-2021 to see it in context.
- Plain-language summary written by qwen3:4b on October 4, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.