FDAClass IIIMay 29, 2024

Xelpros recall: Particulate Matter

Xelpros (latanoprost ophthalmic emulsion) 0.005%, 125mcg/2.5mL, 2.5 mL bottle, Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd., India., NDC…

Why was Xelpros recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: HAD3383A, Exp 8/31/2024

Product
Xelpros (latanoprost ophthalmic emulsion) 0.005%, 125mcg/2.5mL, 2.5 mL bottle, Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd., India., NDC…
Recalling firm
SUN PHARMACEUTICAL INDUSTRIES INC
Quantity
35,069 bottles
Distribution
TX, PA
Recall date
May 29, 2024
Classification
Class III
Status
Ongoing
Agency
FDA (drug)
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