Class IIIOngoing

Xelpros (latanoprost ophthalmic emulsion) 0.005% recall

FDA recall D-0502-2024 · initiated Apr 22, 2024

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.

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 →

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0502-2024 ↗

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