Sun Pharmaceutical Xelpros Ophthalmic Emulsion Recall: Particulate Matter Risk
Sun Pharmaceutical recalls Xelpros (latanoprost) 0.005% ophthalmic emulsion due to particulate matter test failure. This may cause eye irritation or injury. Affected units have specific NDC and lot numbers.
Lower-risk recall
Failed Release Testing: Out of specification for particulate matter test.
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What happened, in plain English
Sun Pharmaceutical is recalling Xelpros eye drops because they failed a test for tiny particles. This could cause eye irritation or injury if used. The recall affects specific batches with a known lot number and expiration date. Read more at govinfonow.com/recall/32720-sun-pharmaceutical-xelpros-ophthalmic-emulsion-recall-particulate-matter-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/32720-sun-pharmaceutical-xelpros-ophthalmic-emulsion-recall-particulate-matter-risk · Updated August 17, 2026 · FDA enforcement record: FDA #D-0502-2024
Cite this page
“Sun Pharmaceutical Xelpros Ophthalmic Emulsion Recall: Particulate Matter Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32720-sun-pharmaceutical-xelpros-ophthalmic-emulsion-recall-particulate-matter-risk. Based on FDA recall #D-0502-2024 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0502-2024%22&limit=1).
Why it’s dangerous
The eye drops failed a test for tiny particles. These particles could enter the eye during use, causing irritation or injury. The risk is low but requires careful handling.
Who’s affected
Prescription users of Xelpros eye drops with the specific NDC 47335-317-90 and lot number HAD3383A are affected. People with this batch may experience eye irritation or injury.
How to tell if you have this one
Check for the NDC code 47335-317-90 and lot number HAD3383A on the bottle. The product expires August 31, 2024. This recall applies only to prescription eye drops.
- Brand
Sun Pharmaceutical- Category
Drug
What to do — step by step
Check Product Details
Look for NDC 47335-317-90 and lot number HAD3383A on the bottle label.
Where it went and when
Where it was distributed
Distributed in Pennsylvania and Texas.
FDA distribution: “TX, PA” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Pennsylvania, Texas.
Recall timeline
FDA published this recall 37 days after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
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-0502-2024 (April 22, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0502-2024 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.