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Class III · Lower riskActive recall

Xelpros

Unlikely to cause harm — often a labeling or packaging issue.

Does this affect you?
Check your lot numberLot #: HAD3383A, Exp 8/31/2024
Where it was soldTX, PA
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made bySun Pharmaceutical Ind. Ltd., India foreign manufacturer
Brand nameXELPROS
Generic nameLATANOPROST
Active ingredient(s)LATANOPROST
Distributed by / forSUN PHARMACEUTICAL INDUSTRIES INC
NDC47335-317-90
Show the full FDA record
Full product labelXelpros (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 firmSUN PHARMACEUTICAL INDUSTRIES INC
DistributionTX, PA
Quantity35,069 bottles
Recall initiated2024-04-22
Report date2024-05-29
Recall completed—
Recall numberD-0502-2024
ClassificationClass III
FDA statusOngoing
Origin on filePrinceton NJ United States

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.