Sun Pharma Cequa Ophthalmic Solution Recall: Subpotent Drug and Particulate Matter Risk
Sun Pharma recalls Cequa (cyclosporine ophthalmic solution) 0.09% due to subpotent drug levels and particulate matter. Affected units have NDC 47335-506-96, lots 10014/10016, expiring 08/2022. Consumers should contact Sun Pharma for details.
Lower-risk recall
Subpotent Drug and Presence of Particulate Matter: low out-of-specification results obtained for assay and the presence of particulate matter.
Contact the company
What happened, in plain English
Sun Pharma is recalling Cequa (cyclosporine ophthalmic solution) 0.09% because lab tests found the drug strength was too low and there were particles in the solution. This could lead to ineffective treatment or eye irritation for people using the medication. Read more at govinfonow.com/recall/35026-sun-pharma-cequa-ophthalmic-solution-recall-subpotent-drug-and-particulate.
Source Summary by GovInfoNow · govinfonow.com/recall/35026-sun-pharma-cequa-ophthalmic-solution-recall-subpotent-drug-and-particulate · Updated August 18, 2026 · FDA enforcement record: FDA #D-0770-2022
Cite this page
“Sun Pharma Cequa Ophthalmic Solution Recall: Subpotent Drug and Particulate Matter Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35026-sun-pharma-cequa-ophthalmic-solution-recall-subpotent-drug-and-particulate. Based on FDA recall #D-0770-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0770-2022%22&limit=1).
Why it’s dangerous
The medication contains less active drug than intended, which might not work well for treating eye inflammation. Particulate matter could cause eye irritation or block the medication's effectiveness.
Who’s affected
People using Cequa for eye conditions, especially those with autoimmune diseases requiring immunosuppressants. Those with sensitive eyes may experience irritation or ineffective treatment.
How to tell if you have this one
Check for the product name 'Cequa' (0.09% cyclosporine ophthalmic solution) in 6 pouches with 10 single-use vials per box. The NDC code is 47335-506-96, and affected lots are 10014 or 10016, expiring in August 2022.
- Brand
Sun Pharma- Category
Drug
What to do — step by step
Check Product Details
Look for the NDC code 47335-506-96 on the box, and check the lot number (10014 or 10016) and expiration date (08/2022).
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide 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 16 months after the firm started it.
- Firm started the recall
- Published in FDA’s Enforcement Report
- FDA classified it Class III
- 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-0770-2022 (April 1, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0770-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 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.