Sun Pharma Cequa Ophthalmic Solution Recall: Subpotent Risk
Sun Pharma recalls Cequa (cyclosporine ophthalmic solution) 0.09% due to subpotent results. This may affect medication effectiveness. Check NDC 47335-506-96, lots 10026/10027, expiring 09/2023.
Lower-risk recall
Subpotent: Out of Specification result observed for low assay
Contact the company
What happened, in plain English
Sun Pharma is recalling Cequa ophthalmic solution vials because they tested lower than expected. This could mean the medication isn't as strong as it should be, which might not work well for eye conditions. Read more at govinfonow.com/recall/33134-sun-pharma-cequa-ophthalmic-solution-recall-subpotent-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/33134-sun-pharma-cequa-ophthalmic-solution-recall-subpotent-risk · Updated August 17, 2026 · FDA enforcement record: FDA #D-1172-2023
Cite this page
“Sun Pharma Cequa Ophthalmic Solution Recall: Subpotent Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/33134-sun-pharma-cequa-ophthalmic-solution-recall-subpotent-risk. Based on FDA recall #D-1172-2023 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1172-2023%22&limit=1).
Why it’s dangerous
The medication tested lower than the required strength (subpotent). This means it might not be effective for treating eye conditions like uveitis. However, the risk of serious harm is low since it's a prescription drug used carefully.
Who’s affected
People with prescriptions for Cequa ophthalmic solution who received vials with NDC 47335-506-96, lots 10026 or 10027, expiring September 2023. Those with eye conditions requiring immunosuppressant treatment are most at risk.
How to tell if you have this one
Check the NDC code 47335-506-96 on the vial packaging. Look for lot numbers 10026 or 10027. The expiration date is September 2023.
- Brand
Sun Pharma- Category
Drug
What to do — step by step
Check Medication Details
Look for NDC 47335-506-96, lot numbers 10026 or 10027, and expiration date September 2023 on the vial packaging.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide wide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 5 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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-1172-2023 (September 7, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1172-2023 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 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.