Xelpros (latanoprost ophthalmic emulsion) 0.005% recall
FDA recall D-0502-2024 · initiated Apr 22, 2024
SUN PHARMACEUTICAL INDUSTRIES INC recalled Xelpros (latanoprost ophthalmic emulsion) 0.005% in Apr 2024 — an FDA Class III recall (D-0502-2024) because Failed Release Testing: Out of specification for particulate matter test.
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was recalled
Failed Release Testing: Out of specification for particulate matter test.
Something got into the product
A physical or chemical contaminant was found — glass or metal fragments, or a solvent that should not be there.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 35,069 bottles
Details
- Product
- Xelpros (latanoprost ophthalmic emulsion) 0.005%, 125mcg/2.5mL, 2.5 mL bottle, Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd., India., NDC 47335-317-90
- Recalling company
- Sun Pharm Industries
- Classification
- Class III
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- TX, PA
- Initiated
- Apr 22, 2024
- FDA report date
- May 29, 2024
This recall is linked to a product we cover: Xelpros →
Frequently asked
- Was Xelpros (latanoprost ophthalmic emulsion) 0.005% recalled?
- SUN PHARMACEUTICAL INDUSTRIES INC recalled Xelpros (latanoprost ophthalmic emulsion) 0.005% in Apr 2024 — an FDA Class III recall (D-0502-2024) because Failed Release Testing: Out of specification for particulate matter test. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was Xelpros (latanoprost ophthalmic emulsion) 0.005% recalled?
- Per the FDA enforcement record, the reason for recall D-0502-2024 was: Failed Release Testing: Out of specification for particulate matter test.
- Is a recalled Xelpros (latanoprost ophthalmic emulsion) 0.005% dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Xelpros (latanoprost ophthalmic emulsion) 0.005% are affected?
- Distributed: TX, PA. The recall covers these lots — Lot #: HAD3383A, Exp 8/31/2024. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0502-2024.