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% vials due to subpotent strength and particulates. This affects patients using the medication for eye conditions. Contact Sun Pharma for details.
Lower-risk recall
Subpotent and Presence of Particulates .
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What happened, in plain English
Sun Pharma is recalling Cequa ophthalmic solution vials because they may have reduced potency and contain particles. This could affect the effectiveness of the medication and cause eye irritation or injury. Read more at govinfonow.com/recall/36153-sun-pharma-cequa-ophthalmic-solution-recall-subpotent-and-particulates-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/36153-sun-pharma-cequa-ophthalmic-solution-recall-subpotent-and-particulates-risk · Updated October 4, 2026 · FDA enforcement record: FDA #D-0391-2021
Cite this page
“Sun Pharma Cequa Ophthalmic Solution Recall: Subpotent and Particulates Risk.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36153-sun-pharma-cequa-ophthalmic-solution-recall-subpotent-and-particulates-risk. Based on FDA recall #D-0391-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0391-2021%22&limit=1).
Why it’s dangerous
The medication may not work as intended due to reduced potency, and particles could cause eye irritation or injury when applied. This is a risk for patients using the product for conditions like uveitis or post-surgical eye care.
Who’s affected
Patients prescribed Cequa for eye conditions who have the specific vial packaging described. Those with compromised immune systems or severe eye conditions may be at higher risk.
How to tell if you have this one
Check for vials labeled 'Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouches x 10 single-use vials (0.25 mL each))'. The product was manufactured with Lot # 10009 (exp. 03/2022) or Lot # 10006 (exp. 01/2022).
- Brand
Sun Pharma- Category
Drug
What to do — step by step
Check Product Details
Look for the specific vial packaging and lot numbers mentioned in the recall notice.
Questions people ask
Is this product safe to use?
The recall states the product may have reduced potency and particles, but it is not safe to use without checking the recall details.
How do I know if I have the recalled product?
Check for vials labeled 'Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouches x 10 single-use vials (0.25 mL each))' with Lot # 10009 (exp. 03/2022) or Lot # 10006 (exp. 01/2022).
What should I do if I have the recalled product?
The recall does not specify a remedy, so contact Sun Pharma directly for guidance.
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-0391-2021 — Sun Pharma Sun Pharma Hello, I own a Sun Pharma that is covered by recall D-0391-2021 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-0391-2021 (May 7, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0391-2021 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.