Medications & Supplements/Prescription Drugs

Xelpros Ophthalmic Emulsion Recalled for Failed Particulate Matter Testing

Agency Publication Date: May 20, 2024

Summary

Sun Pharmaceutical Industries Inc is recalling 35,069 bottles of Xelpros (latanoprost ophthalmic emulsion) 0.005%, 125mcg/2.5mL. This prescription eye medication is being recalled because it failed a test for particulate matter, meaning there may be unexpected particles in the liquid. If you are using this product, you should contact your healthcare provider or pharmacist for further guidance.

Risk

The presence of unintended particulate matter in an eye medication can cause irritation or other injury to the eye upon application. No injuries or specific adverse events have been reported in the recall data.

What You Should Do

This recall affects Xelpros (latanoprost ophthalmic emulsion) 0.005%, 125mcg/2.5mL, sold in 2.5 mL bottles with NDC 47335-317-90.
Check the labeling on your prescription bottle or outer carton for lot number HAD3383A and an expiration date of 8/31/2024 to see if your medication is part of this recall.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Sun Pharmaceutical Industries Inc for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for more information.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Xelpros (latanoprost ophthalmic emulsion) 0.005%, 125mcg/2.5mL (2.5 mL bottle)

Variants: 0.005%, 125mcg/2.5mL, 2.5 mL bottle, Rx only

Lot Numbers:

HAD3383A (Exp 8/31/2024)

NDC:

47335-317-90

Recall Number: D-0502-2024; Manufactured by Sun Pharmaceutical Ind. Ltd., India.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94465

Status: Active

Manufacturer: SUN PHARMACEUTICAL INDUSTRIES INC

Manufactured In: India

Units Affected: 35,069 bottles

Distributed To: Texas, Pennsylvania

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects Xelpros (latanoprost ophthalmic emulsion) 0.005%, 125mcg/2.5mL, sold in 2.5 mL bottles with NDC 47335-317-90.

Check the labeling on your prescription bottle or outer carton for lot number HAD3383A and an expiration date of 8/31/2024 to see if your medication is part of this recall.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Sun Pharmaceutical Industries Inc for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for more information.