Reported May 29, 2024 · Ongoing

Xelpros (latanoprost ophthalmic emulsion) 0.005%, 125mcg/2.5mL, 2.5 mL bottle, Rx only, Manufactured by: Sun…

Sun Pharmaceutical Industries Inc.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: SUN PHARMACEUTICAL INDUSTRIES INC · 2 Independence Way · Princeton, NJ · 08540-6620

Is this the product you have?

  • Xelpros (latanoprost ophthalmic emulsion) 0.005%, 125mcg/2.5mL, 2.5 mL bottle, Rx only
  • Manufactured bySun Pharmaceutical Ind. Ltd., India., NDC 47335-317-90
Lot codes and dates
    • Lot #: HAD3383A
    • Exp 8/31/2024
Amount recalled
35,069 bottles

Where it was sold

Why it was recalled

Failed Release Testing: Out of specification for particulate matter test.

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Data as of Sep 19, 5:54 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.