Class III โ€” Low Risk

Low risk โ€” use of or exposure to this product is not likely to cause adverse health consequences.

Xelpros (latanoprost ophthalmic emulsion) 0.005% Recalled by SUN PHARMACEUTICAL INDUSTRIES INC Due to Failed Release Testing: Out of specification for particulate...

Date: April 22, 2024
Company: SUN PHARMACEUTICAL INDUSTRIES INC
Status: Ongoing
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact SUN PHARMACEUTICAL INDUSTRIES INC directly.

Affected Products

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

Quantity: 35,069 bottles

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed to 2 states: PA, TX

Affected (2 states)Not affected

About SUN PHARMACEUTICAL INDUSTRIES INC

SUN PHARMACEUTICAL INDUSTRIES INC has 86 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report